Sickle Cell Disease Clinical Trial
Official title:
Mindfulness and Yoga Therapy for Acute Pain in Sickle Cell Disease
Verified date | February 2023 |
Source | University of Texas Southwestern Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 39 |
Est. completion date | February 2, 2023 |
Est. primary completion date | February 2, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria: - Patients with sickle cell disease, any genotype - Adult patients at least 18 years of age - English speaking - Admitted to Clements University Hospital with an acute vaso-occlusive pain crisis Exclusion criteria: - Unable to follow simple instructions - Admitted to the intensive care unit |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Southwestern Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 12 weeks | ||
Primary | Feasibility of the intervention as measured by the proportion of participants who accessed the mindfulness videos during their hospitalization | 12 weeks | ||
Primary | 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. | at the time of hospital discharge, up to 6 months post-intervention | |
Primary | 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. | at the time of hospital discharge, up to 6 months post-intervention | |
Primary | Participant engagement as measured by the number of mindfulness videos watched by each participant during their hospitalization | at the time of hospital discharge, up to 6 months post-intervention | ||
Primary | 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 |
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