A Prospective Study Investigating the Use of Relaxation Prior to Medical Procedures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Boston Children's Hospital
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 14 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Arms & Interventions
Placebo Group
- 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
Intervention: Placebo Group (Device)
Experimental (Buddhify) Group
- 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
Intervention: Buddhify Therapy (Device)
Control Group
- Pre-Procedure
- Blood pressure, pulse, and respiration rate
- State-Trait Anxiety Inventory
- PROCEDURE
- Post-procedure -Rate pain level of procedure
Outcomes
Primary Outcomes
Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure
Time Frame: 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
Time Frame: 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
Time Frame: Pre-therapy/pre-procedure
Pre-therapy/pre-procedure stress level measured by pulse in beats per minute.
Pre-therapy/Pre-procedure Anxiety Level
Time Frame: 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 Outcomes
- Eat in Last Hour(Pre-therapy/Pre-procedure)
- Post-therapy/Pre-procedure Change in Stress Level Measured by Pulse(Post-therapy/pre-procedure)
- Exercise in Last Hour(Pre-therapy/Pre-procedure)
- Number of Injections(Pre-therapy/Pre-procedure)
- Injection Experiences(Pre-therapy/Pre-procedure)
- Post-therapy/Pre-procedure Change in Anxiety Level(Post-therapy/pre-procedure)
- Drink in Last Hour(Pre-therapy/Pre-procedure)
- Post-therapy/Pre-procedure Change in Stress Level Measured by Respiration Rate(Post-therapy/pre-procedure)
- Perceived Pain Level of the Procedure as Assessed by the Wong-Baker FACES Pain Rating Scale(Immediately post-procedure)
- Post-therapy/Pre-procedure Change in Stress Level Measured by Blood Pressure(Post-therapy/Pre-procedure)
Investigators
Gianmichel Corrado
Gianmichel D. Corrado, MD
Boston Children's Hospital
