A Prospective Study Investigating the Use of Relaxation Prior to Medical Procedures.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Study Investigating the Use of Relaxation Prior to Medical Procedures

Conditions
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Pain, Anxiety

Intervention / Treatment
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* Device: Placebo Group
* Device: Buddhify Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 14 and older undergoing an invasive procedure by Dr. Gianmichel Corrado at the Division of Sports Medicine of Boston Children's Hospital. Exclusion Criteria:

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Group<br>Pre-Placebo therapy Blood pressure, pulse, and respiration rate State-Trait Anxiety Inventory PLACEBO THERAPY SESSION Post-Placebo therapy/Pre-procedure Blood pressure, pulse, and respiration rate State-Trait Anxiety Inventory PROCEDURE Post-procedure -Rate pain level of procedure | Device: Placebo Group<br>* The placebo group will wear headphones and listen to nature sounds.<br>|
| Experimental: Experimental (Buddhify) Group<br>Pre-Buddhify therapy Blood pressure, pulse, and respiration rate State-Trait Anxiety Inventory BUDDHIFY THERAPY SESSION Post-Buddhify therapy/Pre-procedure Blood pressure, pulse, and respiration rate State-Trait Anxiety Inventory PROCEDURE Post-procedure -Rate pain level of procedure | Device: Buddhify Therapy<br>* 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.<br>|
| No Intervention: Control Group<br>Pre-Procedure Blood pressure, pulse, and respiration rate State-Trait Anxiety Inventory PROCEDURE Post-procedure -Rate pain level of procedure | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Buddhify, Stress, Anxiety, Relaxation Technique