NCT02459847

Brief Summary

The objectives of this pilot study are to: (1) evaluate acute effects of biofeedback and mindfulness training on pain, anxiety, and stress during a hand therapy visit and (2) gain understanding of patient perceptions, preferences, and experiences with mind-body interventions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

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, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 2, 2015

Completed
Last Updated

November 17, 2021

Status Verified

November 1, 2021

Enrollment Period

9 months

First QC Date

November 7, 2014

Last Update Submit

November 9, 2021

Conditions

Arm InjuriesHand Injuries

Outcome Measures

Primary Outcomes (1)

  • Change in Salivary Cortisol throughout duration of intervention

    0, 20, 40 and 60 minutes from start of intervention session

Secondary Outcomes (6)

  • Change in State Anxiety Inventory throughout duration of intervention

    0, 20, 40 and 60 minutes from start of intervention session

  • Change in Visual Analogue Pain Scale throughout duration of intervention

    0, 20, 40 and 60 minutes from start of intervention session

  • Change from Baseline in Mindfulness Attention Awareness Scale at 2 weeks

    Baseline and 2 weeks

  • Change from Baseline in Disabilities of the Arm, Shoulder, and Hand (DASH) Outcome Measure at 2 weeks

    Baseline and 2 weeks

  • Change from Baseline in Five Facet Mindfulness Questionnaire - Short Form at 2 weeks

    Baseline and 2 weeks

  • +1 more secondary outcomes

Study Arms (2)

Mindfulness

EXPERIMENTAL

Two sessions, each lasting 60-minutes total. The first session involves standard hand therapy care for the entire session. The second session begins with the participant listening to a 19-minute audio-recorded body scan (i.e., mindfulness training), followed by standard care.

Behavioral: Mindfulness TrainingOther: Standard Care

Biofeedback

EXPERIMENTAL

Two sessions, each lasting 60-minutes total. The first session involves standard hand therapy care for the entire session. The second session begins with the participant receiving 20 minutes of visual biofeedback training using sonographic imaging (i.e., sonographic biofeedback), followed by standard care.

Behavioral: Sonographic BiofeedbackOther: Standard Care

Interventions

Mindfulness TrainingBEHAVIORAL
Mindfulness
Sonographic BiofeedbackBEHAVIORAL
Biofeedback
Standard CareOTHER
BiofeedbackMindfulness

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Referral to USC Keck Hospital Hand Clinic
  • Upper extremity pathology resulting in decreased hand use
  • Pain with activity greater than 4 out of 10
  • Scheduled to attend at least 2 therapy sessions per week
  • Speak and read English
  • Able to independently read and respond to questionnaires

You may not qualify if:

  • Cast or open wounds in the distal upper extremity
  • Bilateral upper extremity pathology involvement
  • Significant visual or hearing deficit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC Keck Hospital Hand Clinic

Los Angeles, California, 90033, United States

Location

Related Publications (3)

  • Hardison ME, Roll SC. Mindfulness Interventions in Physical Rehabilitation: A Scoping Review. Am J Occup Ther. 2016 May-Jun;70(3):7003290030p1-9. doi: 10.5014/ajot.2016.018069.

    PMID: 27089297BACKGROUND

  • Roll SC, Hardison ME, Vigen C, Black DS. Mindful Body Scans and Sonographic Biofeedback as Preparatory Activities to Address Patient Psychological States in Hand Therapy: A Pilot Study. Hand Ther. 2020 Sep;25(3):98-106. doi: 10.1177/1758998320930752. Epub 2020 Jun 9.

    PMID: 33244321RESULT

  • Takata SC, Hardison ME, Roll SC. Fostering Holistic Hand Therapy: Emergent Themes of Client Experiences of Mind-Body Interventions. OTJR (Thorofare N J). 2020 Apr;40(2):122-130. doi: 10.1177/1539449219888835. Epub 2019 Nov 25.

    PMID: 31762376RESULT

MeSH Terms

Conditions

Arm InjuriesHand Injuries

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Shawn C Roll, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 7, 2014

First Posted

June 2, 2015

Study Start

August 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

November 17, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)