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Completed

NCT Number: NCT05572294

Mindfulness and Yoga Therapy for Acute Pain in Sickle Cell Disease

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.

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Key information

Conditions

Sickle Cell Crisis Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Sickle Cell Disease Vaso-Occlusive Crises

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness meditation, breathing exercises (including incentive spirometry), and yoga therapy

Behavioral

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.

Primary outcomes

  1. 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

  2. Feasibility of the intervention as measured by the proportion of participants who accessed the mindfulness videos during their hospitalization

    Time frame: 12 weeks

  3. Acceptability of the intervention as measured by the proportion of participants who found the mindfulness practices enjoyable and/or helpful

    Time frame: at 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.

  4. Acceptability of the intervention as measured by the proportion of participants who are interested in pursuing mindfulness therapies in the future

    Time frame: at 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.

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 7, 2022
Registry last updated
Feb 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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