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Clinical Trials/NCT02690194
NCT02690194CompletedNot Applicable

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

Boston Children's Hospital1 site in 1 country54 target enrollmentStarted: August 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Placebo Comparator
  1. Pre-Placebo therapy
  • Blood pressure, pulse, and respiration rate
  • State-Trait Anxiety Inventory
  1. PLACEBO THERAPY SESSION
  2. Post-Placebo therapy/Pre-procedure
  • Blood pressure, pulse, and respiration rate
  • State-Trait Anxiety Inventory
  1. PROCEDURE
  2. Post-procedure -Rate pain level of procedure

Intervention: Placebo Group (Device)

Experimental (Buddhify) Group

Experimental
  1. Pre-Buddhify therapy
  • Blood pressure, pulse, and respiration rate
  • State-Trait Anxiety Inventory
  1. BUDDHIFY THERAPY SESSION
  2. Post-Buddhify therapy/Pre-procedure
  • Blood pressure, pulse, and respiration rate
  • State-Trait Anxiety Inventory
  1. PROCEDURE
  2. Post-procedure -Rate pain level of procedure

Intervention: Buddhify Therapy (Device)

Control Group

No Intervention
  1. Pre-Procedure
  • Blood pressure, pulse, and respiration rate
  • State-Trait Anxiety Inventory
  1. PROCEDURE
  2. 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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gianmichel Corrado

Gianmichel D. Corrado, MD

Boston Children's Hospital

Study Sites (1)

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