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The primary aim is to investigate the efficacy of Buddhify relaxation therapy in reducing the stress and anxiety levels of patients. The secondary aim is to investigate the effect of prior stress and anxiety levels on the perceived pain level of undergoing a medical procedure, reported post-procedure.
Undergoing medical procedures is reported to cause stress and anxiety among many individuals.This can trigger the sympathetic nervous response, including decreased skin temperature, increased pulse, and increased blood pressure. While evolutionary advantageous, this response has deleterious effects on the healing process. Heightened stress levels can also trigger an increased release of cortisol, a naturally produced steroid hormone known to hinder the immune response. In response to high levels of stress, a patient's tolerance for pain decreases and the perceived pain level increases.
Relaxation techniques can assist in reducing the stress and anxiety levels of a patient, which allows for lower perceived pain and more rapid healing. Many relaxation techniques exist, including acupuncture, child life intervention, breathing therapy and guided imagery. Buddhify, a mobile application, incorporates breathing therapy and audio-guided imagery into brief relaxation sessions, with the goal of reducing the stress and anxiety levels of the user. This application presents a convenient option for patients to use prior to undergoing a procedure. If proven to be effective, this application could be more widely used to help reduce the stress level, anxiety level and subsequent perceived pain level of patients, ultimately improving their healing reaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group | Placebo Comparator |
|
|
| Experimental (Buddhify) Group | Experimental |
|
|
| Control Group | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Group | Device | The placebo group will wear headphones and listen to nature sounds. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure | Pre-therapy/pre-procedure stress level measured by blood pressure in mmHg | Pre-therapy/pre-procedure |
| Pre-therapy/Pre-procedure Stress Level Measured by Pulse | Pre-therapy/pre-procedure stress level measured by pulse in beats per minute. | Pre-therapy/pre-procedure |
| Pre-therapy/Pre-procedure Stress Level Measured by Respiratory Rate | Pre-therapy/pre-procedure stress level measured by respiratory rate in breaths per minute. | Pre-therapy/pre-procedure |
| Pre-therapy/Pre-procedure Anxiety Level | Pre-therapy/pre-procedure anxiety level measure by the State-Trait Anxiety Inventory. The scale ranges from a minimum score of 40 to a maximum score of 160 with a higher score indicating higher levels of anxiety. | Pre-therapy/pre-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Post-therapy/Pre-procedure Change in Stress Level Measured by Pulse | Post-therapy/pre-procedure change in stress level measured by pulse in beats per minute. Value at prost-therapy/pre-procedure minus value at pre-therapy/pre-procedure. | Post-therapy/pre-procedure |
| Post-therapy/Pre-procedure Change in Stress Level Measured by Respiration Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gianmichel Corrado, MD | Boston Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Childrens Hospital - Sports Medicine | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25254059 | Background | Bae H, Bae H, Min BI, Cho S. Efficacy of acupuncture in reducing preoperative anxiety: a meta-analysis. Evid Based Complement Alternat Med. 2014;2014:850367. doi: 10.1155/2014/850367. Epub 2014 Sep 2. | |
| 22092955 | Background | Ko YL, Lin PC. The effect of using a relaxation tape on pulse, respiration, blood pressure and anxiety levels of surgical patients. J Clin Nurs. 2012 Mar;21(5-6):689-97. doi: 10.1111/j.1365-2702.2011.03818.x. Epub 2011 Nov 17. |
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Control group data was not analyzed for all measures
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Group |
Placebo Group: The placebo group will wear headphones and listen to nature sounds. |
| FG001 | Experimental (Buddhify) Group |
Buddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions. |
| FG002 | Control Group |
|
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
For the control group there were no post-therapy/pre-procedure data collected because there was no therapy for the control group.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Group |
Placebo Group: The placebo group will wear headphones and listen to nature sounds. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure | Pre-therapy/pre-procedure stress level measured by blood pressure in mmHg | Posted | Mean | Standard Deviation | mmHg | Pre-therapy/pre-procedure |
|
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All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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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 | Placebo Group |
Placebo Group: The placebo group will wear headphones and listen to nature sounds. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Greggory Kobelski | Boston Children's Hospital | 7812161093 | Greggory.Kobelski@childrens.harvard.edu |
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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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| Buddhify Therapy | Device | The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions. |
|
Post-therapy/pre-procedure stress level measured by respiratory rate in breaths per minute. Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure. |
| Post-therapy/pre-procedure |
| Post-therapy/Pre-procedure Change in Anxiety Level | Post-therapy/Pre-procedure change in anxiety level measure by the State-Trait Anxiety Inventory. Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure. The scale ranges from a minimum score of 40 to a maximum score of 160 with a higher score indicating higher levels of anxiety. | Post-therapy/pre-procedure |
| Post-therapy/Pre-procedure Change in Stress Level Measured by Blood Pressure | Post-therapy/pre-procedure change in stress level measured by blood pressure measured in mmHg. Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure. | Post-therapy/Pre-procedure |
| Perceived Pain Level of the Procedure as Assessed by the Wong-Baker FACES Pain Rating Scale | Perceived pain level of the procedure as assessed by the Wong-Baker FACES pain rating scale 1-10. A score of 1 indicates "no hurt" (a better outcome) while a score of 10 indicates "hurts worst" (worst outcome). | Immediately post-procedure |
| Drink in Last Hour | Indication of if the patient has had a drink in the last hour | Pre-therapy/Pre-procedure |
| Eat in Last Hour | Indication of if the patient has eaten in the last hour | Pre-therapy/Pre-procedure |
| Exercise in Last Hour | Indication of if the patient has exercised in the last hour | Pre-therapy/Pre-procedure |
| Injection Experiences | Indication of prior injection experiences | Pre-therapy/Pre-procedure |
| Number of Injections | Average number of injections for patients that indicated that they previously have had injections | Pre-therapy/Pre-procedure |
| 15110929 | Background | Ebrecht M, Hextall J, Kirtley LG, Taylor A, Dyson M, Weinman J. Perceived stress and cortisol levels predict speed of wound healing in healthy male adults. Psychoneuroendocrinology. 2004 Jul;29(6):798-809. doi: 10.1016/S0306-4530(03)00144-6. |
| 15471050 | Background | Worley CA. 'Why won't this wound heal?' Factors affecting wound repair. Dermatol Nurs. 2004 Aug;16(4):360-1. No abstract available. |
| 24957817 | Background | Lim YC, Yobas P, Chen HC. Efficacy of relaxation intervention on pain, self-efficacy, and stress-related variables in patients following total knee replacement surgery. Pain Manag Nurs. 2014 Dec;15(4):888-96. doi: 10.1016/j.pmn.2014.02.001. Epub 2014 Jun 21. |
| 7475659 | Background | Kiecolt-Glaser JK, Marucha PT, Malarkey WB, Mercado AM, Glaser R. Slowing of wound healing by psychological stress. Lancet. 1995 Nov 4;346(8984):1194-6. doi: 10.1016/s0140-6736(95)92899-5. |
| 25271180 | Background | Heilbrunn BR, Wittern RE, Lee JB, Pham PK, Hamilton AH, Nager AL. Reducing anxiety in the pediatric emergency department: a comparative trial. J Emerg Med. 2014 Dec;47(6):623-31. doi: 10.1016/j.jemermed.2014.06.052. Epub 2014 Sep 27. |
| 33904781 | Derived | Sugimoto D, Slick NR, Mendel DL, Stein CJ, Pluhar E, Fraser JL, Meehan WP 3rd, Corrado GD. Meditation Monologue can Reduce Clinical Injection-Related Anxiety: Randomized Controlled Trial. J Evid Based Integr Med. 2021 Jan-Dec;26:2515690X211006031. doi: 10.1177/2515690X211006031. |
| BG001 | Experimental (Buddhify) Group |
Buddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions. |
| BG002 | Control Group |
|
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | 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 |
|
| OG002 | Control Group |
|
|
|
| Primary | Pre-therapy/Pre-procedure Stress Level Measured by Pulse | Pre-therapy/pre-procedure stress level measured by pulse in beats per minute. | Posted | Mean | Standard Deviation | Beats per minute | Pre-therapy/pre-procedure |
|
|
|
| Primary | Pre-therapy/Pre-procedure Stress Level Measured by Respiratory Rate | Pre-therapy/pre-procedure stress level measured by respiratory rate in breaths per minute. | Posted | Mean | Standard Deviation | Breaths per minute | Pre-therapy/pre-procedure |
|
|
|
| Primary | Pre-therapy/Pre-procedure Anxiety Level | Pre-therapy/pre-procedure anxiety level measure by the State-Trait Anxiety Inventory. The scale ranges from a minimum score of 40 to a maximum score of 160 with a higher score indicating higher levels of anxiety. | Posted | Mean | Standard Deviation | score on a scale | Pre-therapy/pre-procedure |
|
|
|
| Secondary | Post-therapy/Pre-procedure Change in Stress Level Measured by Pulse | Post-therapy/pre-procedure change in stress level measured by pulse in beats per minute. Value at prost-therapy/pre-procedure minus value at pre-therapy/pre-procedure. | No data were collected for the control group in this Outcome Measure | Posted | Mean | 95% Confidence Interval | Beats per minute | Post-therapy/pre-procedure |
|
|
|
| Secondary | Post-therapy/Pre-procedure Change in Stress Level Measured by Respiration Rate | Post-therapy/pre-procedure stress level measured by respiratory rate in breaths per minute. Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure. | No data were collected for the control group in this Outcome Measure. | Posted | Mean | 95% Confidence Interval | Breaths per minute | Post-therapy/pre-procedure |
|
|
|
| Secondary | Post-therapy/Pre-procedure Change in Anxiety Level | Post-therapy/Pre-procedure change in anxiety level measure by the State-Trait Anxiety Inventory. Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure. The scale ranges from a minimum score of 40 to a maximum score of 160 with a higher score indicating higher levels of anxiety. | No data were collected for the control group in this Outcome Measure. | Posted | Mean | 95% Confidence Interval | score on a scale | Post-therapy/pre-procedure |
|
|
|
| Secondary | Post-therapy/Pre-procedure Change in Stress Level Measured by Blood Pressure | Post-therapy/pre-procedure change in stress level measured by blood pressure measured in mmHg. Value at post-therapy/pre-procedure minus value at pre-therapy/pre-procedure. | No data were collected for the control group in this Outcome Measure. | Posted | Mean | 95% Confidence Interval | mmHg | Post-therapy/Pre-procedure |
|
|
|
| Secondary | Perceived Pain Level of the Procedure as Assessed by the Wong-Baker FACES Pain Rating Scale | Perceived pain level of the procedure as assessed by the Wong-Baker FACES pain rating scale 1-10. A score of 1 indicates "no hurt" (a better outcome) while a score of 10 indicates "hurts worst" (worst outcome). | Posted | Mean | Standard Deviation | score on a scale | Immediately post-procedure |
|
|
|
| Secondary | Drink in Last Hour | Indication of if the patient has had a drink in the last hour | Posted | Count of Participants | Participants | Pre-therapy/Pre-procedure |
|
|
|
| Secondary | Eat in Last Hour | Indication of if the patient has eaten in the last hour | Posted | Count of Participants | Participants | Pre-therapy/Pre-procedure |
|
|
|
| Secondary | Exercise in Last Hour | Indication of if the patient has exercised in the last hour | Posted | Count of Participants | Participants | Pre-therapy/Pre-procedure |
|
|
|
| Secondary | Injection Experiences | Indication of prior injection experiences | Posted | Count of Participants | Participants | Pre-therapy/Pre-procedure |
|
|
|
| Secondary | Number of Injections | Average number of injections for patients that indicated that they previously have had injections | Patients that have had injections in the past | Posted | Mean | Standard Deviation | Number of injections | Pre-therapy/Pre-procedure |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Experimental (Buddhify) Group |
Buddhify Therapy: The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Control Group |
| 0 | 0 | 0 | 0 | 0 | 0 |
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| Between 18 and 65 years |
|
| >=65 years |
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| Male |
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| Data Not Collected |
|