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| Name | Class |
|---|---|
| Clínica UC San Carlos de Apoquindo. | UNKNOWN |
| Hospital Provicial Dr. Rafael Avaria Valenzuela | UNKNOWN |
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This study will evaluate the efficacy of music (a very well selected list of songs)on improving the tolerance to the colonoscopy. The patients will be randomly assigned to receive music or not. The authors hypothesis is that music is able to improve the tolerance to colonoscopy evaluated as a reduction on the level of anxiety, on the intensity of pain experimented during the procedure and a reduction of the administered dose of midazolam during the colonoscopy.
To select the music that will be administered on this trial we will performed as the first part of the study, a two fase pilot study. In the first part, five song belonging to different musical styles (Rock, Bosa Nova, Classical Music, Popular chilean music and New age) will be heard by 40 persons and the main emotion produced by every song will be registered (chosen among a previously defined list of emotions) and then rated using a visual analog scale. Thus, we will be able to select the musical style that with more frequency produce "tranquility and/or peace". Once this musical style will be selected we generate a set of songs belonging to this style. This set of songs will be validated using again a similar methodology in the second part of the pilot study to be sure that is able to produce the same emotion that the song previously evaluated. The validated set of songs will be the music that will be administered to the patients participating on a multicentric randomized controlled trial where the effect of the selected music over the tolerance to colonoscopy will be evaluated measuring the level of anxiety, the administered dose of midazolam and the intensity of pain experimented during the procedure among another variables on the experimental and the control groups, including 150 patients on each arm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music | Experimental | A previously defined list of songs will be administered by headphones to these patients during the colonoscopy. |
|
| Control | Sham Comparator | These patients will receive an MP3 device (and headphones) which will be functioning but without volume. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music | Other | A previously defined list of songs will be administered by headphones to these patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The administered dose of midazolam | The accumulated dose of midazolam administered during the procedure will be registered and compared between both arms. | After colonoscopy is finished. |
| Level of anxiety | We will use a self-adminsitered questonary (STAI) | rigth before colonoscopy and after it at the moment of discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of vital signs | Heart rate and blood pressure will be measured right before the colonoscopy, five and ten minutes after its start. | Rigth before and during the colonoscopy |
| Colonoscopy time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlos E Benítez, M.D. | Contact | 56-02-3543820 | 3880 | cbenitez@med.puc.cl |
| Name | Affiliation | Role |
|---|---|---|
| Carlos E Benítez, M.D. | Gastroenterology Department. Pontificia Universidad Católica de Chile | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Provicial Dr. Rafael Avaria Valenzuela | Recruiting | Curanilahue | Biobio | 444444 | Chile |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17999189 | Background | Leung FW. Methods of reducing discomfort during colonoscopy. Dig Dis Sci. 2008 Jun;53(6):1462-7. doi: 10.1007/s10620-007-0025-9. | |
| 20452299 | Background | Costa A, Montalbano LM, Orlando A, Ingoglia C, Linea C, Giunta M, Mancuso A, Mocciaro F, Bellingardo R, Tine F, D'Amico G. Music for colonoscopy: A single-blind randomized controlled trial. Dig Liver Dis. 2010 Dec;42(12):871-6. doi: 10.1016/j.dld.2010.03.016. Epub 2010 May 7. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| No music | Other | No music will be administered by the headphones connected to the MP3 device. |
|
The time elapsed since the beginning of the colonoscopy until its end.
| During the colonoscopy |
| Patient's global evaluation of the procedure | After the procedure the patient will evaluate the procedure as : a)Very Bad, b)Bad, c)Good, d)Very Good. | after the colonoscopy at the moment of discharge. |
| Time since the beginning of the procedure until the discharge | The time elapsed since the beginning of the procedure until the discharge. | since the beginning of the procedure until the discharge. |
| How difficult the colonoscopy was? | At the end of the colonoscopy the endocopist will be asking about how difficult the procedure was, choosing one of the following alternatives: a)Less than usual, b) as usual, c) more than usual, d) much more than usual. | After the procedure. |
| Adverse effects | Every unexpected and adverse effect will be registered. | Since the begining of the procedure until the discharge. |
| The level of pain | Using a Visual Analog Scale, the intensity of pain experimented during the colonoscopy will be evaluated after the procedure on both arms. | After colonoscopy at the moment of discharge |
| Willing of repeating the procedure. | After the procedure the patient will be asked about the willingness of repeating the procedure if necesary, choosing one of the following ones: a) Absolutely no, b) Possibly no, c) Possibly yes, d) Absolutely yes. | After colonoscopy at the moment of discharge |
| Centro Médico UC San Joaquín | Recruiting | Santiago | RM | 8320000 | Chile |
|
| Hospital Clínico. Pontificia Universidad Católica de Chile | Recruiting | Santiago | RM | 8330024 | Chile |
|
| Clínica UC San Carlos de Apoquindo | Recruiting | Santiago | Santiago Metropolitan | 8320000 | Chile |
|
| 17143946 | Background | Bechtold ML, Perez RA, Puli SR, Marshall JB. Effect of music on patients undergoing outpatient colonoscopy. World J Gastroenterol. 2006 Dec 7;12(45):7309-12. doi: 10.3748/wjg.v12.i45.7309. |
| 16567885 | Background | Harikumar R, Raj M, Paul A, Harish K, Kumar SK, Sandesh K, Asharaf S, Thomas V. Listening to music decreases need for sedative medication during colonoscopy: a randomized, controlled trial. Indian J Gastroenterol. 2006 Jan-Feb;25(1):3-5. |
| 17167846 | Background | Ovayolu N, Ucan O, Pehlivan S, Pehlivan Y, Buyukhatipoglu H, Savas MC, Gulsen MT. Listening to Turkish classical music decreases patients' anxiety, pain, dissatisfaction and the dose of sedative and analgesic drugs during colonoscopy: a prospective randomized controlled trial. World J Gastroenterol. 2006 Dec 14;12(46):7532-6. doi: 10.3748/wjg.v12.i46.7532. |
| 18785289 | Background | Tam WW, Wong EL, Twinn SF. Effect of music on procedure time and sedation during colonoscopy: a meta-analysis. World J Gastroenterol. 2008 Sep 14;14(34):5336-43. doi: 10.3748/wjg.14.5336. |
| 18483858 | Background | Bechtold ML, Puli SR, Othman MO, Bartalos CR, Marshall JB, Roy PK. Effect of music on patients undergoing colonoscopy: a meta-analysis of randomized controlled trials. Dig Dis Sci. 2009 Jan;54(1):19-24. doi: 10.1007/s10620-008-0312-0. Epub 2008 May 16. |
| 17554644 | Background | Rudin D, Kiss A, Wetz RV, Sottile VM. Music in the endoscopy suite: a meta-analysis of randomized controlled studies. Endoscopy. 2007 Jun;39(6):507-10. doi: 10.1055/s-2007-966362. |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |