NCT02690194

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain
• Anxiety

Interventions

Type	Name	Description
DEVICE	Placebo Group	The placebo group will wear headphones and listen to nature sounds.
DEVICE	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.

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-01-10
• Completion: 2017-01-10
• First posted: 2016-02-24
• Last updated: 2018-12-21
• Results posted: 2018-12-21

Locations

1 site across 1 country: United States