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

Mindfulness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03212105
• Other study ID #: 2015P002349
• Status: Completed
• Phase: N/A
• Start date: October 14, 2016
• Est. completion date: October 2017

Study information

• Verified date: August 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mindfulness
• Orthopaedic Injury

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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

External Links

•   The video-flash mindfulness intervention