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NCT05556057 | Recruiting | Spinal Cord Injuries

Feasibility of Mindfulness Meditation Training and Home Practice in Persons With Spinal Cord Injury
Sponsor:

The University of Texas Health Science Center, Houston

Information provided by (Responsible Party):

Radha Korupalu

Brief Summary:

The purpose of this study is to evaluate the feasibility and acceptability of a 6-week app-guided Mindfulness meditation training (MM) intervention and health education (active control) condition in people with spinal cord injury (SCI) who have chronic pain and to examine the feasibility of data collection procedures

Condition or disease

Spinal Cord Injuries

Intervention/treatment

mindfulness meditation(MM)

Health Education (active control)

Phase

Not Applicable

Detailed Description:

Our multidisciplinary, interinstitutional team of investigators proposes to randomize 60 SCI patients experiencing chronic pain to practice audio-guided MM for ≥ 10 minutes daily for 6 weeks using the free app "Mindfulness Coach" developed by the Department of Veteran Affairs, or to listen or view health education presentations (active control) ≥ 10 minutes daily for 6 weeks on the free TED app (active control). Primary outcomes are the feasibility and acceptability of proposed interventions in people with SCI and chronic pain. Secondary outcomes include the feasibility of collecting patient-reported outcomes of pain, anxiety, depression, mindfulness, quality of life, stress, fatigue and sleep disturbance.}}

Study Type : Interventional
Estimated Enrollment : 60 participants
Masking : Single
Primary Purpose : Other
Official Title : Feasibility of Mindfulness Meditation Training and Home Practice in Persons With Spinal Cord Injury: A Pilot Study
Actual Study Start Date : December 6, 2022
Estimated Primary Completion Date : July 15, 2024
Estimated Study Completion Date : October 30, 2024
Arm Intervention/treatment

Experimental: mindfulness meditation(MM)

Other: mindfulness meditation(MM)

Active Comparator: Health Education

Other: Health Education (active control)
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Traumatic SCI of at least 6 months duration
  • Chronic pain [defined as pain lasting at least 3 months with a pain intensity rating of 4 or higher on a 10-point visual analog scale]
  • Understand spoken and written English sufficiently to provide informed consent
  • participate in the intervention and complete study surveys
Exclusion Criteria
  • Lack of daily access to the internet using a smart phone or smart tablet
  • Cognitive impairment (determined by their inability to demonstrate comprehension of informed consent by correctly answering 4 out of 5 questions pertaining to the study)
  • Significant visual/hearing impairment that does not allow use of the MM app's audiovisual presentations or health education presentations on Ted-talk
  • Use of any kind of meditation more than once a week in the last 3 months
  • Inability to provide or obtain an email address for communication with study staff
Feasibility of Mindfulness Meditation Training and Home Practice in Persons With Spinal Cord Injury

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Feasibility of Mindfulness Meditation Training and Home Practice in Persons With Spinal Cord Injury

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Locations

Recruiting

United States, Texas

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

Recruiting

United States, Texas

TIRR Memorial Hermann

Houston, Texas, United States, 77030