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

NCT ID: NCT02690194

Last Updated: 2018-12-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-01-10

Brief Summary

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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

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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.

Conditions

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Pain Anxiety

Keywords

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Buddhify Stress Anxiety Relaxation Technique

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo Group

1. Pre-Placebo therapy

* Blood pressure, pulse, and respiration rate
* State-Trait Anxiety Inventory
2. PLACEBO THERAPY SESSION
3. Post-Placebo therapy/Pre-procedure

* Blood pressure, pulse, and respiration rate
* State-Trait Anxiety Inventory
4. PROCEDURE
5. Post-procedure -Rate pain level of procedure

Group Type PLACEBO_COMPARATOR

Placebo Group

Intervention Type DEVICE

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

Experimental (Buddhify) Group

1. Pre-Buddhify therapy

* Blood pressure, pulse, and respiration rate
* State-Trait Anxiety Inventory
2. BUDDHIFY THERAPY SESSION
3. Post-Buddhify therapy/Pre-procedure

* Blood pressure, pulse, and respiration rate
* State-Trait Anxiety Inventory
4. PROCEDURE
5. Post-procedure -Rate pain level of procedure

Group Type EXPERIMENTAL

Buddhify Therapy

Intervention Type 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.

Control Group

1. Pre-Procedure

* Blood pressure, pulse, and respiration rate
* State-Trait Anxiety Inventory
2. PROCEDURE
3. Post-procedure -Rate pain level of procedure

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Placebo Group

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

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gianmichel Corrado

Gianmichel D. Corrado, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gianmichel Corrado, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital

Locations

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Boston Childrens Hospital - Sports Medicine

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 25254059 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22092955 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15110929 (View on PubMed)

Worley CA. 'Why won't this wound heal?' Factors affecting wound repair. Dermatol Nurs. 2004 Aug;16(4):360-1. No abstract available.

Reference Type BACKGROUND
PMID: 15471050 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24957817 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7475659 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25271180 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33904781 (View on PubMed)

Other Identifiers

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IRB-P00016464

Identifier Type: -

Identifier Source: org_study_id