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Mindfulness and Yoga Therapy for Acute Pain in Sickle Cell Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05572294
Recruitment Status : Completed
First Posted : October 7, 2022
Last Update Posted : February 13, 2023
Sponsor:
Information provided by (Responsible Party):
Siayareh Rambally, University of Texas Southwestern Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sickle Cell Crisis Sickle Cell Disease Behavioral: Mindfulness meditation, breathing exercises (including incentive spirometry), and yoga therapy Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Mindfulness and Yoga Therapy for Acute Pain in Sickle Cell Disease
Actual Study Start Date : November 10, 2022
Actual Primary Completion Date : February 2, 2023
Actual Study Completion Date : February 2, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Mindfulness and Yoga Therapy
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.


Outcome Measures
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Primary Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05572294


Locations
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United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Siayareh Rambally, M.D. University of Texas Southwestern Medical Center
More Information
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Responsible Party: Siayareh Rambally, Associate Professor, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT05572294    
Other Study ID Numbers: STU-2021-0729
First Posted: October 7, 2022    Key Record Dates
Last Update Posted: February 13, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Siayareh Rambally, University of Texas Southwestern Medical Center:
Sickle Cell Disease
Yoga Therapy
Mindfulness
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Acute Pain
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Pain
Neurologic Manifestations