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Mindfulness and Yoga Therapy for Acute Pain in Sickle Cell Disease

Not Applicable
Completed
Conditions
Sickle Cell Disease
Sickle Cell Crisis
Interventions
Behavioral: Mindfulness meditation, breathing exercises (including incentive spirometry), and yoga therapy
Registration Number
NCT05572294
Lead Sponsor
University of Texas Southwestern Medical Center
Brief Summary

Patients with sickle cell disease suffer from acute and chronic pain that diminishes their quality of life. The purpose of this study is to assess the feasibility and acceptability of mindfulness meditation, breathing exercises, and gentle yoga therapy as supportive measures for the management of acute vaso-occlusive pain crises in the inpatient setting.

Detailed Description

This is a prospective single arm study of mindfulness interventions for sickle cell patients admitted with an acute vaso-occlusive pain crisis. Patients will be accrued over a consecutive 12 week period. All genotypes of sickle cell disease will be eligible for enrollment.

After providing informed consent, the patients will have access to 4 videos on their hospital room television. The videos contain guided mindfulness meditation, breathing exercises (including the use of an incentive spirometer), and gentle yoga therapy that can be performed in the supine position from a hospital bed. Videos vary in length from 5-12 minutes. Participants will have the ability to watch the videos as many times as they choose. They may also turn off the video at any time.

The primary outcome is feasibility and acceptability of the intervention. We will record objective data on how many videos are watched by each participant, as well as the percentage of each video completed. We will obtain information about the participants' perception of the intervention through a post-intervention survey and interview.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
39
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Mindfulness and Yoga TherapyMindfulness meditation, breathing exercises (including incentive spirometry), and yoga therapyParticipants will have access to video-guided mindfulness interventions.
Primary Outcome Measures
NameTimeMethod
Feasibility of the intervention as measured by the proportion of participants who accessed the mindfulness videos during their hospitalization12 weeks
Acceptability of the intervention as measured by the proportion of participants who found the mindfulness practices enjoyable and/or helpfulat the time of hospital discharge, up to 6 months post-intervention

This data will be collected via a post-intervention survey and interview. The survey will contain simple questions with yes/no answer options. The interview will be conducted by a study member, either in-person or by telephone.

Acceptability of the intervention as measured by the proportion of participants who are interested in pursuing mindfulness therapies in the futureat the time of hospital discharge, up to 6 months post-intervention

This data will be collected via a post-intervention survey and interview. The survey will contain simple questions with yes/no answer options. The interview will be conducted by a study member, either in-person or by telephone.

Feasibility of the intervention as measured by the proportion of sickle cell patients admitted over a consecutive 12 week time period who agree to participate in the study12 weeks
Participant engagement as measured by the number of mindfulness videos watched by each participant during their hospitalizationat the time of hospital discharge, up to 6 months post-intervention
Participant engagement as measured by the percentage of videos completed. A video is considered completed if the participant watches more than 85% of the video.at the time of hospital discharge, up to 6 months post-intervention
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

University of Texas Southwestern Medical Center

🇺🇸

Dallas, Texas, United States

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