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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety
• Intervention / Treatment: Device: Placebo Group; Device: Buddhify Therapy

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Childrens Hospital - Sports Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Group; Pre-Placebo therapyBlood pressure, pulse, and respiration rateState-Trait Anxiety Inventory; PLACEBO THERAPY SESSION; Post-Placebo therapy/Pre-procedureBlood pressure, pulse, and respiration rateState-Trait Anxiety Inventory; PROCEDURE; Post-procedure -Rate pain level of procedure	Device: Placebo Group; The placebo group will wear headphones and listen to nature sounds.
Experimental: Experimental (Buddhify) Group; Pre-Buddhify therapyBlood pressure, pulse, and respiration rateState-Trait Anxiety Inventory; BUDDHIFY THERAPY SESSION; Post-Buddhify therapy/Pre-procedureBlood pressure, pulse, and respiration rateState-Trait Anxiety Inventory; PROCEDURE; Post-procedure -Rate pain level of procedure	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.
No Intervention: Control Group; Pre-ProcedureBlood pressure, pulse, and respiration rateState-Trait Anxiety Inventory; PROCEDURE; Post-procedure -Rate pain level of procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-therapy/Pre-procedure Stress Level Measured by Blood Pressure	Pre-therapy/pre-procedure stress level measured by blood pressure in mmHg	Pre-therapy/pre-procedure
Pre-therapy/Pre-procedure Stress Level Measured by Pulse	Pre-therapy/pre-procedure stress level measured by pulse in beats per minute.	Pre-therapy/pre-procedure
Pre-therapy/Pre-procedure Stress Level Measured by Respiratory Rate	Pre-therapy/pre-procedure stress level measured by respiratory rate in breaths per minute.	Pre-therapy/pre-procedure
Pre-therapy/Pre-procedure Anxiety Level	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.	Pre-therapy/pre-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-therapy/Pre-procedure Change in Stress Level Measured by Pulse	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.	Post-therapy/pre-procedure
Post-therapy/Pre-procedure Change in Stress Level Measured by Respiration Rate	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.	Post-therapy/pre-procedure
Post-therapy/Pre-procedure Change in Anxiety Level	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.	Post-therapy/pre-procedure
Post-therapy/Pre-procedure Change in Stress Level Measured by Blood Pressure	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.	Post-therapy/Pre-procedure
Perceived Pain Level of the Procedure as Assessed by the Wong-Baker FACES Pain Rating Scale	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).	Immediately post-procedure
Drink in Last Hour	Indication of if the patient has had a drink in the last hour	Pre-therapy/Pre-procedure
Eat in Last Hour	Indication of if the patient has eaten in the last hour	Pre-therapy/Pre-procedure
Exercise in Last Hour	Indication of if the patient has exercised in the last hour	Pre-therapy/Pre-procedure
Injection Experiences	Indication of prior injection experiences	Pre-therapy/Pre-procedure
Number of Injections	Average number of injections for patients that indicated that they previously have had injections	Pre-therapy/Pre-procedure

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Gianmichel Corrado, MD, Boston Children's Hospital

Publications and helpful links

General Publications

• Heilbrunn BR, Wittern RE, Lee JB, Pham PK, Hamilton AH, Nager AL. Reducing anxiety in the pediatric emergency department: a comparative trial. J Emerg Med. 2014 Dec;47(6):623-31. doi: 10.1016/j.jemermed.2014.06.052. Epub 2014 Sep 27.
• Kiecolt-Glaser JK, Marucha PT, Malarkey WB, Mercado AM, Glaser R. Slowing of wound healing by psychological stress. Lancet. 1995 Nov 4;346(8984):1194-6. doi: 10.1016/s0140-6736(95)92899-5.
• Lim YC, Yobas P, Chen HC. Efficacy of relaxation intervention on pain, self-efficacy, and stress-related variables in patients following total knee replacement surgery. Pain Manag Nurs. 2014 Dec;15(4):888-96. doi: 10.1016/j.pmn.2014.02.001. Epub 2014 Jun 21.
• Bae H, Bae H, Min BI, Cho S. Efficacy of acupuncture in reducing preoperative anxiety: a meta-analysis. Evid Based Complement Alternat Med. 2014;2014:850367. doi: 10.1155/2014/850367. Epub 2014 Sep 2.
• Ko YL, Lin PC. The effect of using a relaxation tape on pulse, respiration, blood pressure and anxiety levels of surgical patients. J Clin Nurs. 2012 Mar;21(5-6):689-97. doi: 10.1111/j.1365-2702.2011.03818.x. Epub 2011 Nov 17.
• Ebrecht M, Hextall J, Kirtley LG, Taylor A, Dyson M, Weinman J. Perceived stress and cortisol levels predict speed of wound healing in healthy male adults. Psychoneuroendocrinology. 2004 Jul;29(6):798-809. doi: 10.1016/S0306-4530(03)00144-6.
• Worley CA. 'Why won't this wound heal?' Factors affecting wound repair. Dermatol Nurs. 2004 Aug;16(4):360-1. No abstract available.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): January 10, 2017
• Study Completion (Actual): January 10, 2017

Study Registration Dates

• First Submitted: February 9, 2016
• First Submitted That Met QC Criteria: February 19, 2016
• First Posted (Estimate): February 24, 2016

Study Record Updates

• Last Update Posted (Actual): December 21, 2018
• Last Update Submitted That Met QC Criteria: December 20, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Anxiety; Stress; Relaxation Technique; Buddhify
• Other Study ID Numbers: IRB-P00016464

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO