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Completed

NCT Number: NCT02690194

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

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.

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Key information

Conditions

Pain Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Childrens Hospital - Sports Medicine

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo Group

Device

The placebo group will wear headphones and listen to nature sounds.

Buddhify Therapy

Device

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.

Primary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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

  1. Post-therapy/Pre-procedure Change in Stress Level Measured by Pulse

    Time frame: 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.

  2. Post-therapy/Pre-procedure Change in Stress Level Measured by Respiration Rate

    Time frame: 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.

  3. Post-therapy/Pre-procedure Change in Anxiety Level

    Time frame: 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.

  4. Post-therapy/Pre-procedure Change in Stress Level Measured by Blood Pressure

    Time frame: 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.

  5. Perceived Pain Level of the Procedure as Assessed by the Wong-Baker FACES Pain Rating Scale

    Time frame: 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).

  6. Drink in Last Hour

    Time frame: Pre-therapy/Pre-procedure

    Indication of if the patient has had a drink in the last hour

  7. Eat in Last Hour

    Time frame: Pre-therapy/Pre-procedure

    Indication of if the patient has eaten in the last hour

  8. Exercise in Last Hour

    Time frame: Pre-therapy/Pre-procedure

    Indication of if the patient has exercised in the last hour

  9. Injection Experiences

    Time frame: Pre-therapy/Pre-procedure

    Indication of prior injection experiences

  10. Number of Injections

    Time frame: Pre-therapy/Pre-procedure

    Average number of injections for patients that indicated that they previously have had injections

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 24, 2016
Registry last updated
Dec 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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