Clinical trial NCT05572294: Mindfulness and Yoga Therapy for Acute Pain in Sickle Cell Disease
Official title: Mindfulness and Yoga Therapy for Acute Pain in Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Crisis
Sickle Cell Disease
Keywords: Sickle Cell Disease
Yoga Therapy
Mindfulness
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2022-10-07
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 12 weeks
measure: Feasibility of the intervention as measured by the proportion of participants who accessed the mindfulness videos during their hospitalization
timeFrame: 12 weeks
measure: Acceptability of the intervention as measured by the proportion of participants who found the mindfulness practices enjoyable and/or helpful
timeFrame: at the time of hospital discharge, up to 6 months post-intervention
measure: Acceptability of the intervention as measured by the proportion of participants who are interested in pursuing mindfulness therapies in the future
timeFrame: at the time of hospital discharge, up to 6 months post-intervention
measure: Participant engagement as measured by the number of mindfulness videos watched by each participant during their hospitalization
timeFrame: at the time of hospital discharge, up to 6 months post-intervention
measure: 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.
timeFrame: at the time of hospital discharge, up to 6 months post-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Siayareh Rambally, M.D.
role: PRINCIPAL_INVESTIGATOR
References: