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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03212105
Enrollment
125
Registered
2017-07-11
Start date
2016-10-14
Completion date
2017-10-31
Last updated
2018-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mindfulness, Orthopaedic Injury

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.

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.

Interventions

BEHAVIORAL60 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.

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

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Client Satisfaction Scale-3 (CSQ-3)Day 1 after completing 60-second interventionThe 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.

Secondary

MeasureTime frameDescription
Change in State-Trait Anxiety Inventory (STAI)Before intervention, immediately after intervention, and 3 months after enrollmentThe 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.
Change in Pain IntensityBefore intervention, immediately after intervention, and 3 months after enrollmentPain 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.
Change in Distress, Anxiety, Depression, and AngerBefore intervention, immediately after intervention, and 3 months after enrollmentA 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026