Clinical trial NCT02690194: A Prospective Study Investigating the Use of Relaxation Prior to Medical Procedures.
Official title: A Prospective Study Investigating the Use of Relaxation Prior to Medical Procedures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Anxiety
Keywords: Buddhify
Stress
Anxiety
Relaxation Technique
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2016-02-24
Enrollment: 54
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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:

Primary outcomes:
measure: Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure
timeFrame: Pre-therapy/pre-procedure
measure: Pre-therapy/Pre-procedure Stress Level Measured by Pulse
timeFrame: Pre-therapy/pre-procedure
measure: Pre-therapy/Pre-procedure Stress Level Measured by Respiratory Rate
timeFrame: Pre-therapy/pre-procedure
measure: Pre-therapy/Pre-procedure Anxiety Level
timeFrame: Pre-therapy/pre-procedure
Secondary outcomes:
measure: Post-therapy/Pre-procedure Change in Stress Level Measured by Pulse
timeFrame: Post-therapy/pre-procedure
measure: Post-therapy/Pre-procedure Change in Stress Level Measured by Respiration Rate
timeFrame: Post-therapy/pre-procedure
measure: Post-therapy/Pre-procedure Change in Anxiety Level
timeFrame: Post-therapy/pre-procedure
measure: Post-therapy/Pre-procedure Change in Stress Level Measured by Blood Pressure
timeFrame: Post-therapy/Pre-procedure
measure: Perceived Pain Level of the Procedure as Assessed by the Wong-Baker FACES Pain Rating Scale
timeFrame: Immediately post-procedure
measure: Drink in Last Hour
timeFrame: Pre-therapy/Pre-procedure
measure: Eat in Last Hour
timeFrame: Pre-therapy/Pre-procedure
measure: Exercise in Last Hour
timeFrame: Pre-therapy/Pre-procedure
measure: Injection Experiences
timeFrame: Pre-therapy/Pre-procedure
measure: Number of Injections
timeFrame: Pre-therapy/Pre-procedure
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Childrens Hospital - Sports Medicine
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Gianmichel Corrado, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Sugimoto D, Slick NR, Mendel DL, Stein CJ, Pluhar E, Fraser JL, Meehan WP 3rd, Corrado GD. Meditation Monologue can Reduce Clinical Injection-Related Anxiety: Randomized Controlled Trial. J Evid Based Integr Med. 2021 Jan-Dec;26:2515690X211006031. doi: 10.1177/2515690X211006031.