An interventional study of Mindfulness meditation, breathing exercises (including incentive spirometry), and yoga therapy in Sickle Cell Crisis and Sickle Cell Disease, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-13.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Supportive care
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.
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.
1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.
This study's enrollment of 39 is close to the median of 40 across 750 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
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Exclusion criteria:
Participants will have access to video-guided mindfulness interventions.
Behavioral: Mindfulness meditation, breathing exercises (including incentive spirometry), and yoga therapy
Sickle cell patients admitted with a vaso-occlusive pain crisis over a consecutive 12-week period will be offered participation in the study. After providing informed consent, participants will have access to 4 videos containing guided mindfulness meditation, breathing exercises, and gentle yoga therapy. The videos are 5-12 minutes long and taught by a physical therapist who is also certified in yoga therapy. Participants may turn off the video at any time. Participants will have access to the videos for the duration of their hospitalization, and they may watch the videos as many times as they desire.
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 study
Time frame: 12 weeks
Feasibility of the intervention as measured by the proportion of participants who accessed the mindfulness videos during their hospitalization
Time frame: 12 weeks
Acceptability of the intervention as measured by the proportion of participants who found the mindfulness practices enjoyable and/or helpful
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.
Time frame: at the time of hospital discharge, up to 6 months post-intervention
Acceptability of the intervention as measured by the proportion of participants who are interested in pursuing mindfulness therapies in the future
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.
Time frame: at the time of hospital discharge, up to 6 months post-intervention
Participant engagement as measured by the number of mindfulness videos watched by each participant during their hospitalization
Time frame: at 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.
Time frame: at the time of hospital discharge, up to 6 months post-intervention
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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University of Texas Southwestern Medical Center