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Primary dysmenorrhea is defined as lower abdominal pain that occurs during menses and is not secondary to any type of pelvic disease. It is considered the most common condition in reproductive age women. First line of treatment are non-steroidal anti-inflammatory drugs (NSAIDS), or oral contraceptives (OCC). This two forms of treatment have not demonstrated 100% efficacy, and adverse events and contraindications for both exist. Moreover, studies have demonstrated that an important women do not use, or don't like to use, pharmacological treatment. Music have demonstrated analgesic effects in different clinical contexts, and has emerged as an important form of complementary therapy in the management of pain. To the researcher's knowledge, no studies have been conducted to evaluate music's effectiveness in pain secondary to primary dysmenorrhea.
The following is the protocol for a randomized, single blinded, clinical trial, where an experimental group listened to a 30 minute song, and was compared to a control group that rest in silence for the same time and conditions. It was expected that music will produce a larger, and significant, effect on pain reduction when compared to the control silence group according to pain measured through a 10 cm Visual Analogue Scale (VAS) in young women from the School of Medicine and Health Sciences at the Universidad del Rosario, Bogota DC, Colombia. Additionally, the investigators wanted to evaluate the clinical effect of music and analgesic requirements, anxiety and vital signs were also measured.
Primary Dysmenorrhea (PD) is defined as pain in the lower abdomen, that occurs always during menses, in the absence of pelvic pathology, and lasts about 24-72 hours. It initiates during the first 24 months after menarche. Other symptoms like, emotional lability, anxiety, nausea, headache, and others may accompany the pain. It is considered the most common condition of reproductive age women, and is considered one of the most important causes for school or work absence in this population.
Music has been proposed as a complementary therapy for the management of pain, and a large body of clinical evidence supports its use on clinical context. Additionally, functional imaging research has found that music activates areas related to pain modulation and perception like the periaqueductal gray matter. Moreover music seems to modify brain activity during pain perception. Music has been shown to be effective in relieving pain secondary to surgery, in cancer related pain, and other types of pain, but it has not been studied for primary dysmenorrhea.
This randomized clinical trial was designed with the following objectives
General Objective: To evaluate the efficacy of music listening, compared to a control group that rested in silence, in the painful experience secondary to primary dysmenorrhea in women of 18 years or older from the School of Medicine and Health Sciences at the Universidad del Rosario, Bogotá DC., Colombia.
Specific Objectives:
The investigators hypothesized that listening to an instrumental song, unknown to the patient, will have a significant effect on pain relief. Additionally, investigators hypothesized that music listening will have a clinical effect big enough to also impact analgesic requirements and anxiety scores .
Primary endpoint was pain reduction from the moment before to after the intervention. Pain reduction is the better way to evaluate analgesia efficacy and was the proper approach for these protocol's main objective, which was efficacy of music on pain relief secondary to primary dysmenorrhea.
For achieving these aims and answering research questions, a randomized clinical trial was designed. As patients can't be blinded from listening or not to music, a single blinded approach was decided. Furthermore, methodology for recruitment was designed to blind patients from allocation until the day of the intervention and a speech was used to avoid patients to identify the primary endpoint. Additionally, patients were explained that two interventions were used, but it was not specified that silence group was the control group, to assure proper blinding and avoid further bias of results. Silence was decided as a control intervention as comparison with drug placebo may not be adequate due to differences in the types of intervention.
To isolate the music effects the investigators decided on using a completely new and unknown song. The song was planned and composed exclusively for the research, so all patients allocated to the music group listened to the exact same musical piece.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music group | Experimental | Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise. |
|
| Silence group | Active Comparator | Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music group | Behavioral | The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain From 1-5 Minutes Before (Baseline) to 1- 5 Minutes After the Intervention | Pain scores were measured using a visual analogue scale (VAS) of 10 cm (0 no pain at all, and 10 the worst possible pain) at each time point. Main outcome was calculated from the difference between visual analogue score at 1-5 minutes after (VAS3) minus visual analogue score at 1-5 minutes before the intervention (VAS2). | From 1-5 minutes before the intervention (baseline) to 1-5 minutes after the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Usual Pain Associated to Menses | Mean pain scores measured with a 10 cm visual analogue scale (VAS) where 0 was no pain at all and 10 the worst possible pain. Usual pain was evaluated before the intervention and was known as VAS 1. | 5-10 minutes before the intervention. |
| Actual Pain 1-5 Minutes Before the Intervention (Baseline). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan S Martin-Saavedra, MD | Universidad del Rosario | Principal Investigator |
| Angela M Ruiz-Sternberg, MD, MSc | Universidad del Rosario | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Escuela de Medicina y Ciencias de la Salud- Universidad del Rosario | Bogotá | Capital District | 111211 | Colombia |
Results fromt the research will be made available as supplemental data or digital content published with the final manuscript. Additional information like the study protocol, statistic analysis plan performed, and copy of the informed consent will be available by request to the email: juans.martin@urosario.edu.co
Complete database will be made available with publication of the manuscript. Other information will be accessible by request to the email: juans.martin@urosario.edu.co
Complete database results will be available as digital content with the final manuscript. Additional data will be given by request by email and requester will require to send a letter with signature stating the reason for requesting additional information.
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A total of 597 participants were excluded: 470 did not met inclusion criteria, 98 declined to participate, and 29 signed consent but never came for randomization and the intervention.
Patients were recruited and between September 2017 to April 2018 from the School of Medicine and Health Sciences, and the School of Mathematics and Natural Sciences from Universidad del Rosario. Assessment, data collection, and intervention occurred within the facilities of the School of Medicine and Health Sciences from Universidad del Rosario, Bogota D.C., Colombia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Music Group | Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise. Music group: The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital). |
| FG001 | Silence Group | Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise. Silence Group: Audio file that contained no sounds. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary Endpoint |
| ||||||||||||||||
| 3-6 Hours Post Intervention Outcomes |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Music Group | Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise. Music group: The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain From 1-5 Minutes Before (Baseline) to 1- 5 Minutes After the Intervention | Pain scores were measured using a visual analogue scale (VAS) of 10 cm (0 no pain at all, and 10 the worst possible pain) at each time point. Main outcome was calculated from the difference between visual analogue score at 1-5 minutes after (VAS3) minus visual analogue score at 1-5 minutes before the intervention (VAS2). | Intention to treat analysis used | Posted | Mean | Standard Deviation | cm | From 1-5 minutes before the intervention (baseline) to 1-5 minutes after the intervention. |
|
Up to 6 weeks
This is a non-pharmacological intervention, could be classified as behavior, which does not pose any physical, chemical or other type of harm that could be deadly.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Music Group | Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise. Music group: The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital). |
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Patient was not blinded given it is impossible to blind someone from listening to music.
Early termination leading to smaller number of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Juan Sebastian Martin Saavedra | Universidad del Rosario | 2672200532 | juans.martin@urosario.edu.co |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 18, 2017 | May 26, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017699 | Pelvic Pain |
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| ID | Term |
|---|---|
| C084121 | SIR1 protein, S cerevisiae |
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Single blinded, two parallel group, randomized clinical trial. The experimental group received listen to a son composed exclusively for this trial while control group rested for the same amount of time in silence.
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Computer block randomization was used to generate allocation sequence of codes. Allocation was done on the same day of the intervention, patients were given opaque envelope according to the randomization codes. The envelop contained instructions to access the allocated intervention. After baseline data collection patients entered the intervention room and opened the envelop inside while investigator waited outside. Both patients had headphones on and used the same device to access the intervention assuring blinding of the investigator. After the intervention ended, patient closed the intervention file and account to the intervention. All patients were instructed to nor reveal or comment anything about the intervention at any time after the intervention was completed.
|
|
| Silence Group | Behavioral | Audio file that contained no sounds. |
|
|
Mean pain scores measured with a 10 cm visual analogue scale (VAS) where 0 was no pain at all and 10 the worst possible pain. Actual pain was evaluated immediately before the intervention and was known as VAS 2. |
| 1-5 minutes before the intervention. |
| Actual Pain 1-5 Minutes After the Intervention. | Mean pain scores measured with a 10 cm visual analogue scale (VAS) where 0 was no pain at all and 10 the worst possible pain. Actual pain was evaluated immediately after the intervention was completed, and was known as VAS 3. | 1-5 minutes after the intervention. |
| Actual Pain 3-6 Hours After the Intervention. | Mean pain scores measured with a 10 cm visual analogue scale (VAS) where 0 was no pain at all and 10 the worst possible pain. Actual pain was evaluated 3-6 hours after the intervention was completed, and was known as VAS 4. | 3-6 hours after the intervention. |
| Anxiety Score Before the Intervention | Using a validated short spanish version of the Zung anxiety scale, anxiety was measured before the intervention. The scale was composed of 10 items. Each item had a 4 Likert point scale (0= never, 1= some times, 2= most of the time, and 3 = always). Final scores ranged from 0, minimum anxiety, and 30 maximum anxiety. | 1-5 minutes before the intervention. |
| Anxiety Score After the Intervention | Using a validated short spanish version of the Zung anxiety scale, anxiety was measured after the intervention. The scale was composed of 10 items. Each item had a 4 Likert point scale (1= never, 2= some times, 3= most of the time, and 4 = always). Scores ranged from 10, minimum anxiety, and 40 maximum anxiety. For analysis, mean quantitative scores were obtained so 1 was equivalent to minimum anxiety, and 4 to maximum anxiety. | 1-5 minutes after the intervention. |
| Anxiety Score 3-6 Hours After the Intervention | Using a validated short spanish version of the Zung anxiety scale, anxiety was measured 3-6 hours after the intervention. The scale was composed of 10 items. Each item had a 4 Likert point scale (0= never, 1= some times, 2= most of the time, and 3= always). Scores ranged from 0, minimum anxiety, and 30 maximum anxiety. | 3-6 hours after fter the intervention. |
| Analgesic Requirements Before | Before the intervention patients were asked if they wanted to use any analgesic drug or do any kind of analgesic strategy. Patients simply answered yes or no. | 1-5 minutes before the intervention the intervention. |
| Analgesic Requirements After | After the intervention patients were asked if they wanted to use any analgesic drug or do any kind of analgesic strategy. Patients simply answered yes or no. | 1-5 minutes after the intervention. |
| Analgesic Use During a Period of 3-6 Hours After the Intervention. | After the intervention, all patients had to register all analgesic drugs (e.g. ibuprofen) or strategy (e.g. local heat) that were used until last pain measurement (VAS 4, 3-6 hours after the intervention). | 3-6 hours after the intervention) |
| Systolic Blood Pressure Before the Intervention | Systolic blood pressure in mmHg measured with a calibrated digital sphygmomanometer before the intervention. | 1-5 minutes before the intervention. |
| Diastolic Blood Pressure Before the Intervention | Diastolic blood pressure in mmHg measured with a calibrated digital sphygmomanometer before the intervention. | 1-5 minutes before the intervention. |
| Heart Rate Before the Intervention | Heart rate measured in beats per minute (bpm) with a calibrated digital sphygmomanometer before the intervention. | 1-5 minutes before the intervention. |
| Mean Blood Pressure Before the Intervention | Mean blood pressure in mmHg measured with a calibrated digital sphygmomanometer before the intervention. | 1-5 minutes before the intervention. |
| Systolic Blood Pressure After the Intervention | Systolic blood pressure in mmHg measured with a calibrated digital sphygmomanometer after the intervention. | 1-5 minutes after the intervention. |
| Diastolic Blood Pressure After the Intervention | Diastolic blood pressure in mmHg measured with a calibrated digital sphygmomanometer after the intervention. | 1-5 minutes after the intervention. |
| Heart Rate After the Intervention | Heart rate in beats per minute (bpm) measured with a calibrated digital sphygmomanometer after the intervention. | 1-5 minutes after the intervention. |
| Mean Blood Pressure After the Intervention | Mean blood pressure in mmHg measured with a calibrated digital sphygmomanometer after the intervention. | 1-5 minutes after the intervention. |
| NOT COMPLETED |
|
|
| BG001 | Silence Group | Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise. Silence Group: Audio file that contained no sounds. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| University program | Count of Participants | Participants |
|
| Academic semester | Count of Participants | Participants |
|
| Presence of comorbidities | Count of Participants | Participants |
|
| History of surgeries in their lifetime | Count of Participants | Participants |
|
| Age at menarche | Mean | Standard Deviation | years |
|
| Intermenstrual time | Mean | Standard Deviation | days |
|
| Duration of menses | Mean | Standard Deviation | days |
|
| Type of menstrual pain | Count of Participants | Participants |
|
| First ever menstrual pain | Count of Participants | Participants |
|
| Menstrual pain onset | Count of Participants | Participants |
|
| Menstrual pain duration | Count of Participants | Participants |
|
| Analgesic used on last menstrual period | Count of Participants | Participants |
|
| Non-pharmacologic treatment used in last menstrual period | Count of Participants | Participants |
|
| Usual menstrual pain - Visual Analogue Scale (VAS1) | Participants were asked to indicate their usual menstrual pain in a Visual Analogue Scale ranging 0 cm (no pain at al) to 10 cm (worst pain ever) | Mean | Standard Deviation | units on a scale |
|
| Analgesia 1 | Patient were asked if they wanted to use any analgesic prior to the starting the study intervention (no analgesic given) | Count of Participants | Participants |
|
| Pain pre-intervention - Visual Analogue Scale (VAS2) | Patient's were asked to rate their pain immediately prior to starting their allocated intervention using a Visual Analogue Scale ranging 0 cm (no pain at al) to 10 cm (worst pain ever) | Mean | Standard Deviation | units on a scale |
|
| Anxiety (A1) - Abbreviated Zung anxiety scale | Patients completed the abbreviated Zung anxiety scale in spanish immediately before receiving the allocated intervention. The scale has a total of 10 questions with 4 possible answers "never", "some times", "often", and "always". Each question will have a score of minimum 0 and maximum 3. The final score ranges between 0 and 30. | Mean | Standard Deviation | units on a scale |
|
| Hours with pain | Patient were asked how many hours they have had their current menstrual pain immediately before receiving the allocated intervention | Mean | Standard Deviation | hours |
|
| Systolic blood pressure | Obtained immediately prior to receiving the allocated intervention | Measured pressures in one patient of the silence group was deleted by mistake. Only the measure prior to receiving the intervention were deleted | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure | Obtained immediately before receiving allocated intervention | Measured pressures in one patient of the silence group was deleted by mistake. Only the measure prior to receiving the intervention were deleted | Mean | Standard Deviation | mmHg |
|
| Mean arterial blood pressure | Obtained immediately prior to receiving the allocated intervention | Measured pressures in one patient of the silence group was deleted by mistake. Only the measure prior to receiving the intervention were deleted | Mean | Standard Deviation | mmHg |
|
| Heart rate | Obtained immediately prior to receiving the allocated intervention | Measured heart rate in one patient of the silence group was deleted by mistake. Only the measure prior to receiving the intervention was deleted | Mean | Standard Deviation | bpm |
|
| OG001 | Silence Group | Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise. Silence Group: Audio file that contained no sounds. |
|
|
|
| Secondary | Usual Pain Associated to Menses | Mean pain scores measured with a 10 cm visual analogue scale (VAS) where 0 was no pain at all and 10 the worst possible pain. Usual pain was evaluated before the intervention and was known as VAS 1. | Posted | Mean | Standard Deviation | cm | 5-10 minutes before the intervention. |
|
|
|
|
| Secondary | Actual Pain 1-5 Minutes Before the Intervention (Baseline). | Mean pain scores measured with a 10 cm visual analogue scale (VAS) where 0 was no pain at all and 10 the worst possible pain. Actual pain was evaluated immediately before the intervention and was known as VAS 2. | Posted | Mean | Standard Deviation | cm | 1-5 minutes before the intervention. |
|
|
|
|
| Secondary | Actual Pain 1-5 Minutes After the Intervention. | Mean pain scores measured with a 10 cm visual analogue scale (VAS) where 0 was no pain at all and 10 the worst possible pain. Actual pain was evaluated immediately after the intervention was completed, and was known as VAS 3. | Posted | Mean | Standard Deviation | units on a scale | 1-5 minutes after the intervention. |
|
|
|
|
| Secondary | Actual Pain 3-6 Hours After the Intervention. | Mean pain scores measured with a 10 cm visual analogue scale (VAS) where 0 was no pain at all and 10 the worst possible pain. Actual pain was evaluated 3-6 hours after the intervention was completed, and was known as VAS 4. | Posted | Mean | Standard Deviation | units on a scale | 3-6 hours after the intervention. |
|
|
|
|
| Secondary | Anxiety Score Before the Intervention | Using a validated short spanish version of the Zung anxiety scale, anxiety was measured before the intervention. The scale was composed of 10 items. Each item had a 4 Likert point scale (0= never, 1= some times, 2= most of the time, and 3 = always). Final scores ranged from 0, minimum anxiety, and 30 maximum anxiety. | Posted | Mean | Standard Deviation | score on a scale | 1-5 minutes before the intervention. |
|
|
|
|
| Secondary | Anxiety Score After the Intervention | Using a validated short spanish version of the Zung anxiety scale, anxiety was measured after the intervention. The scale was composed of 10 items. Each item had a 4 Likert point scale (1= never, 2= some times, 3= most of the time, and 4 = always). Scores ranged from 10, minimum anxiety, and 40 maximum anxiety. For analysis, mean quantitative scores were obtained so 1 was equivalent to minimum anxiety, and 4 to maximum anxiety. | Posted | Mean | Standard Deviation | score on a scale | 1-5 minutes after the intervention. |
|
|
|
|
| Secondary | Anxiety Score 3-6 Hours After the Intervention | Using a validated short spanish version of the Zung anxiety scale, anxiety was measured 3-6 hours after the intervention. The scale was composed of 10 items. Each item had a 4 Likert point scale (0= never, 1= some times, 2= most of the time, and 3= always). Scores ranged from 0, minimum anxiety, and 30 maximum anxiety. | Posted | Mean | Standard Deviation | score on a scale | 3-6 hours after fter the intervention. |
|
|
|
|
| Secondary | Analgesic Requirements Before | Before the intervention patients were asked if they wanted to use any analgesic drug or do any kind of analgesic strategy. Patients simply answered yes or no. | Posted | Count of Participants | Participants | 1-5 minutes before the intervention the intervention. |
|
|
|
|
| Secondary | Analgesic Requirements After | After the intervention patients were asked if they wanted to use any analgesic drug or do any kind of analgesic strategy. Patients simply answered yes or no. | Posted | Count of Participants | Participants | 1-5 minutes after the intervention. |
|
|
|
|
| Secondary | Analgesic Use During a Period of 3-6 Hours After the Intervention. | After the intervention, all patients had to register all analgesic drugs (e.g. ibuprofen) or strategy (e.g. local heat) that were used until last pain measurement (VAS 4, 3-6 hours after the intervention). | Posted | Count of Participants | Participants | 3-6 hours after the intervention) |
|
|
|
|
| Secondary | Systolic Blood Pressure Before the Intervention | Systolic blood pressure in mmHg measured with a calibrated digital sphygmomanometer before the intervention. | Posted | Mean | Standard Deviation | mmHg | 1-5 minutes before the intervention. |
|
|
|
|
| Secondary | Diastolic Blood Pressure Before the Intervention | Diastolic blood pressure in mmHg measured with a calibrated digital sphygmomanometer before the intervention. | Posted | Mean | Standard Deviation | mmHg | 1-5 minutes before the intervention. |
|
|
|
|
| Secondary | Heart Rate Before the Intervention | Heart rate measured in beats per minute (bpm) with a calibrated digital sphygmomanometer before the intervention. | Posted | Mean | Standard Deviation | bpm | 1-5 minutes before the intervention. |
|
|
|
|
| Secondary | Mean Blood Pressure Before the Intervention | Mean blood pressure in mmHg measured with a calibrated digital sphygmomanometer before the intervention. | Posted | Mean | Standard Deviation | mmHg | 1-5 minutes before the intervention. |
|
|
|
|
| Secondary | Systolic Blood Pressure After the Intervention | Systolic blood pressure in mmHg measured with a calibrated digital sphygmomanometer after the intervention. | Posted | Mean | Standard Deviation | mmHg | 1-5 minutes after the intervention. |
|
|
|
|
| Secondary | Diastolic Blood Pressure After the Intervention | Diastolic blood pressure in mmHg measured with a calibrated digital sphygmomanometer after the intervention. | Posted | Mean | Standard Deviation | mmHg | 1-5 minutes after the intervention. |
|
|
|
|
| Secondary | Heart Rate After the Intervention | Heart rate in beats per minute (bpm) measured with a calibrated digital sphygmomanometer after the intervention. | Posted | Mean | Standard Deviation | bpm | 1-5 minutes after the intervention. |
|
|
|
|
| Secondary | Mean Blood Pressure After the Intervention | Mean blood pressure in mmHg measured with a calibrated digital sphygmomanometer after the intervention. | Posted | Mean | Standard Deviation | mmHg | 1-5 minutes after the intervention. |
|
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 0 |
| 29 |
| EG001 | Silence Group | Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise. Silence Group: Audio file that contained no sounds. | 0 | 23 | 0 | 23 | 0 | 23 |
Not provided
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| Physiotherapy |
|
| Psychology |
|
| Other (Epidemiology, Gynecology, Biology) |
|
| Mixed |
|
| 1-6 months after menarche |
|
| 6-12 months after menarche |
|
| Other |
|
| Less than 24 hours before |
|
| 48-24 hours before |
|
| Other |
|
| Less than 10 hours |
|
| 48-72 hours |
|
| Other |
|
| 0.006 |
| Adjusted mean difference |
| 1.429 |
| 2-Sided |
| Superiority |
Adjusted means: music 3.131 (99% CI 2.62, 3.999) and silence 4.56 (99% CI 3.581, 5.538), F= 8.44, R-square 54.5% |
| 0.370 |
| Adjusted mean difference |
| 0.721 |
| 2-Sided |
Adjusted means: music 2.58 (99% CI 1.339, 3.829), and silence 3.305 (1.728, 4.881); F 0.827, R-square 27.2% |
| Superiority |