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

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.

Study Overview

• Status: Completed
• Conditions: Mindfulness; Orthopaedic Injury
• Intervention / Treatment: Behavioral: 60 Second Video; Other: Educational Brochure

Detailed Description

A cognitive behavioral therapy practice called Acceptance and Commitment Therapy (ACT) focuses on acceptance rather than control of thoughts, emotions and physical sensations, regardless of their quality. The crux of ACT is teaching patients to separate themselves from their thoughts (e.g., cognitive defusion) and thus decrease the importance placed on them. ACT has been successful in treating psychological disorders and emotional disturbances alone or when associated with physical illnesses, those that cause pain in particular. While ACT is effective, it may not be feasible for busy orthopedic practices. However, simple exercises that teach patients to deemphasize the importance they place on thoughts might be feasible in orthopedic settings where patients present with pain and strong emotions. An ACT exercise, delivered before the orthopedic appointment, has the potential to set the tone for a more positive experience for both patient and provider, by lowering a patient's pain intensity, state anxiety (e.g., anxiety symptoms in the present moment) as measured comprehensively by State-Trait Anxiety Inventory (STAI) questionnaire, distress, depression, anger, and anxiety, all four measured by 1 item emotional thermometers (visual scales used to rate different emotions). This exercise might help patients see ACT exercises as a helpful part of their recovery. Some might be motivated to learn more and to continue using them at home. This could improve their recovery from and adjustment to the medical condition.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 60 Second Video; 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; 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.
Other: Educational Pamphlet; The educational pamphlet contains information about pain and stress, which patients will be able to read within 60 seconds.	Other: Educational Brochure; The educational pamphlet will contain information about pain and stress, which patients will be able to read within 60 seconds.; Other Names: Placebo comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in State-Trait Anxiety Inventory (STAI)	The STAI questionnaire measures trait and state anxiety. The questionnaire has 20 items based on a 4-point scale. A higher score is indicative of greater anxiety.	Before intervention, immediately after intervention, and 3 months after enrollment
Change in Pain Intensity	Pain intensity as measured by ordinal rating of pain. On a scale from 0-10, where 0 is no pain and 10 is the worst pain imagined.	Before intervention, immediately after intervention, and 3 months after enrollment
Change in Distress, Anxiety, Depression, and Anger	A visual scale using 4 emotional thermometers to measure each distress, anxiety, depression, and anger. The scale is from 0-10, where 0 means experience none of the emotion and 10 is extreme.	Before intervention, immediately after intervention, and 3 months after enrollment

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital

Publications and helpful links

Helpful Links

• The video-flash mindfulness intervention

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: July 6, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 15, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2015P002349

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No