NCT02690194

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 24, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2017

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

December 21, 2018

Completed
Last Updated

December 21, 2018

Status Verified

December 1, 2018

Enrollment Period

1.4 years

First QC Date

February 9, 2016

Results QC Date

September 4, 2018

Last Update Submit

December 20, 2018

Conditions

PainAnxiety

Keywords

BuddhifyStressAnxietyRelaxation Technique

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (10)

  • Post-therapy/Pre-procedure Change in Stress Level Measured by Pulse

    Post-therapy/pre-procedure

  • Post-therapy/Pre-procedure Change in Stress Level Measured by Respiration Rate

    Post-therapy/pre-procedure

  • Post-therapy/Pre-procedure Change in Anxiety Level

    Post-therapy/pre-procedure

  • Post-therapy/Pre-procedure Change in Stress Level Measured by Blood Pressure

    Post-therapy/Pre-procedure

  • Perceived Pain Level of the Procedure as Assessed by the Wong-Baker FACES Pain Rating Scale

    Immediately post-procedure

  • +5 more secondary outcomes

Study Arms (3)

Placebo Group

PLACEBO COMPARATOR

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

Device: Placebo Group

Experimental (Buddhify) Group

EXPERIMENTAL

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

Device: Buddhify Therapy

Control Group

NO INTERVENTION

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

Interventions

Placebo GroupDEVICE

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

Placebo Group
Buddhify TherapyDEVICE

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.

Experimental (Buddhify) Group

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 14 and older undergoing an invasive procedure by Dr. Gianmichel Corrado at the Division of Sports Medicine of Boston Children's Hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Childrens Hospital - Sports Medicine

Boston, Massachusetts, 02115, United States

Location

Related Publications (8)

  • 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.

    PMID: 25254059BACKGROUND

  • 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.

    PMID: 22092955BACKGROUND

  • 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.

    PMID: 15110929BACKGROUND

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

    PMID: 15471050BACKGROUND

  • 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.

    PMID: 24957817BACKGROUND

  • 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.

    PMID: 7475659BACKGROUND

  • 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.

    PMID: 25271180BACKGROUND

  • 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.

    PMID: 33904781DERIVED

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Results Point of Contact

Title
Greggory Kobelski
Organization
Boston Children's Hospital
Greggory.Kobelski@childrens.harvard.edu
7812161093

Study Officials

  • Gianmichel Corrado, MD

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Gianmichel D. Corrado, MD

Study Record Dates

First Submitted

February 9, 2016

First Posted

February 24, 2016

Study Start

August 1, 2015

Primary Completion

January 10, 2017

Study Completion

January 10, 2017

Last Updated

December 21, 2018

Results First Posted

December 21, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)