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

Not Applicable

Completed

• Conditions: Pain; Anxiety
• Interventions: Device: Placebo Group; Device: Buddhify Therapy

• Registration Number: NCT02690194
• Lead Sponsor: Boston Children's Hospital

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-02-09
• Study First Submitted QC: 2016-02-19
• Study First Posted: 2016-02-24
• Primary Completion: 2017-01-10
• Study Completion: 2017-01-10
• Results First Submitted: 2018-09-04
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-20
• Last Update Submitted: 2018-12-20
• Results First Posted: 2018-12-21
• Last Update Posted: 2018-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo Group	1. Pre-Placebo therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. PLACEBO THERAPY SESSION 3. Post-Placebo therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure
Experimental (Buddhify) Group	Buddhify Therapy	1. Pre-Buddhify therapy * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 2. BUDDHIFY THERAPY SESSION 3. Post-Buddhify therapy/Pre-procedure * Blood pressure, pulse, and respiration rate * State-Trait Anxiety Inventory 4. PROCEDURE 5. Post-procedure -Rate pain level of procedure

Primary Outcome Measures

Name	Time	Method
Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure	Pre-therapy/pre-procedure	Pre-therapy/pre-procedure stress level measured by blood pressure in mmHg
Pre-therapy/Pre-procedure Stress Level Measured by Respiratory Rate	Pre-therapy/pre-procedure	Pre-therapy/pre-procedure stress level measured by respiratory rate in breaths per minute.
Pre-therapy/Pre-procedure Stress Level Measured by Pulse	Pre-therapy/pre-procedure	Pre-therapy/pre-procedure stress level measured by pulse in beats per minute.
Pre-therapy/Pre-procedure Anxiety Level	Pre-therapy/pre-procedure	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.

Secondary Outcome Measures

Name	Time	Method
Injection Experiences	Pre-therapy/Pre-procedure	Indication of prior injection experiences
Post-therapy/Pre-procedure Change in Anxiety Level	Post-therapy/pre-procedure	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.
Drink in Last Hour	Pre-therapy/Pre-procedure	Indication of if the patient has had a drink in the last hour
Post-therapy/Pre-procedure Change in Stress Level Measured by Respiration Rate	Post-therapy/pre-procedure	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.
Perceived Pain Level of the Procedure as Assessed by the Wong-Baker FACES Pain Rating Scale	Immediately post-procedure	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).
Eat in Last Hour	Pre-therapy/Pre-procedure	Indication of if the patient has eaten in the last hour
Post-therapy/Pre-procedure Change in Stress Level Measured by Pulse	Post-therapy/pre-procedure	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.
Exercise in Last Hour	Pre-therapy/Pre-procedure	Indication of if the patient has exercised in the last hour
Post-therapy/Pre-procedure Change in Stress Level Measured by Blood Pressure	Post-therapy/Pre-procedure	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.
Number of Injections	Pre-therapy/Pre-procedure	Average number of injections for patients that indicated that they previously have had injections

Trial Locations

Locations (1)

Boston Childrens Hospital - Sports Medicine; 🇺🇸 Boston, Massachusetts, United States