A 60-seconds Personalized Mindfulness Video Exercise for Patients With Orthopedic Illness

NCT03212105 | Completed

• 1 other identifier: 2015P002349
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine within a randomized controlled trial the feasibility of a 60-second acceptance based mindfulness exercise for patients with musculoskeletal pain versus usual medical care. Feasibility will be evaluated as the number of individuals approached who agree to participate and the number of individuals who drop out prior to completion of post intervention questionnaires. The investigators aim to determine the usefulness and acceptability of the 60-second acceptance based mindfulness exercise for patients with musculoskeletal pain as compared to usual medical care. Usefulness and acceptability will be assessed with the Client Satisfaction Scale-3 (CSQ-3). The investigators also aim to determine whether participating in a personalized 60-second acceptance based mindfulness exercise (e.g., intervention) is associated with significantly more improvement in patients' ratings of state anxiety and pain intensity (co-primary outcomes), and to determine if Distress, Anxiety, Depression and Anger (secondary outcomes) decrease compared to a brief educational pamphlet (e.g., control). The investigators also aim to determine whether any improvements observed will maintain within a 3 month follow up.

Conditions

Orthopaedic Injury; Mindfulness

Outcome Measures

Primary Outcomes (1)

• Client Satisfaction Scale-3 (CSQ-3)

  The client satisfaction scale-3 (CSQ-3) is a 3 question instrument to measure satisfaction with health and human services. Responses are based on a 4-point scale. The score range is from 3-12, where higher values indicate higher satisfaction.

  Day 1 after completing 60-second intervention

Secondary Outcomes (3)

• Change in State-Trait Anxiety Inventory (STAI)

  Before intervention, immediately after intervention, and 3 months after enrollment

• Change in Pain Intensity

  Before intervention, immediately after intervention, and 3 months after enrollment

• Change in Distress, Anxiety, Depression, and Anger

  Before intervention, immediately after intervention, and 3 months after enrollment

Study Arms (2)

60 Second Video

ACTIVE COMPARATOR

The mindfulness intervention is a video-flash found at http://www.pixelthoughts.co. In this exercise patients are asked to write down a concern or worry, and watch it get put into perspective within a 60 seconds time frame.

Behavioral: 60 Second Video

Educational Pamphlet

OTHER

The educational pamphlet contains information about pain and stress, which patients will be able to read within 60 seconds.

Other: Educational Brochure

Interventions

60 Second Video BEHAVIORAL

The mindfulness intervention will be a video-flash found at http://www.pixelthoughts.co. In this exercise patients are asked to write down a concern or worry, and watch it get put into perspective within a 60 seconds time frame.

60 Second Video

Educational Brochure OTHER

The educational pamphlet will contain information about pain and stress, which patients will be able to read within 60 seconds.

Also known as: Placebo comparator

Educational Pamphlet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients presenting to Hand and Upper Extremity Service at Massachusetts General Hospital
• English fluency and literacy

You may not qualify if:

• Pregnant women
• Significant Axis I or II psychopathology that would interfere with participation in the study
• Age \< 18 years old

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Links

• The video-flash mindfulness intervention

MeSH Terms

Interventions

Videotape Recording

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Ana-Maria Vranceanu, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: July 11, 2017
• Study Start: October 14, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: August 17, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)