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

• ClinicalTrials.gov Identifier: NCT02690194
• Recruitment Status: Completed
• First Posted: February 24, 2016
• Results First Posted: December 21, 2018
• Last Update Posted: December 21, 2018
• Sponsor: Boston Children's Hospital
• Information provided by (Responsible Party): Gianmichel Corrado, Boston Children's Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain; Anxiety	Device: Placebo Group; Device: Buddhify Therapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Prospective Study Investigating the Use of Relaxation Prior to Medical Procedures
• Study Start Date: August 2015
• Actual Primary Completion Date: January 10, 2017
• Actual Study Completion Date: January 10, 2017

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo Group; Pre-Placebo therapy Blood pressure, pulse, and respiration rate State-Trait Anxiety Inventory; PLACEBO THERAPY SESSION; Post-Placebo therapy/Pre-procedure Blood pressure, pulse, and respiration rate State-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 therapy Blood pressure, pulse, and respiration rate State-Trait Anxiety Inventory; BUDDHIFY THERAPY SESSION; Post-Buddhify therapy/Pre-procedure Blood pressure, pulse, and respiration rate State-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-Procedure Blood pressure, pulse, and respiration rate State-Trait Anxiety Inventory; PROCEDURE; Post-procedure -Rate pain level of procedure

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

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

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:

Contacts and Locations

Locations

United States, Massachusetts

Boston Childrens Hospital - Sports Medicine

Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Boston Children's Hospital

Investigators

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

More Information

Publications:

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.

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.

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

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Gianmichel Corrado, Gianmichel D. Corrado, MD, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT02690194
• Other Study ID Numbers: IRB-P00016464
• First Posted: February 24, 2016
• Results First Posted: December 21, 2018
• Last Update Posted: December 21, 2018
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Gianmichel Corrado, Boston Children's Hospital:

Buddhify; Stress; Anxiety; Relaxation Technique