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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02690194
• Other study ID #: IRB-P00016464
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: January 10, 2017

Study information

• Verified date: December 2018
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: January 10, 2017
• Est. primary completion date: January 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Anxiety
• Pain

Intervention

Device:
• Placebo Group
The placebo group will wear headphones and listen to nature sounds.
• 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.

Locations

Country	Name	City	State
United States	Boston Childrens Hospital - Sports Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Worley CA. 'Why won't this wound heal?' Factors affecting wound repair. Dermatol Nurs. 2004 Aug;16(4):360-1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Drink in Last Hour	Indication of if the patient has had a drink in the last hour	Pre-therapy/Pre-procedure
Secondary	Eat in Last Hour	Indication of if the patient has eaten in the last hour	Pre-therapy/Pre-procedure
Secondary	Exercise in Last Hour	Indication of if the patient has exercised in the last hour	Pre-therapy/Pre-procedure
Secondary	Injection Experiences	Indication of prior injection experiences	Pre-therapy/Pre-procedure
Secondary	Number of Injections	Average number of injections for patients that indicated that they previously have had injections	Pre-therapy/Pre-procedure