Mindfulness and Yoga Therapy for Acute Pain in Sickle Cell Disease

• ClinicalTrials.gov Identifier: NCT05572294
• Recruitment Status: Completed
• First Posted: October 7, 2022
• Last Update Posted: February 13, 2023
• Sponsor: University of Texas Southwestern Medical Center
• Information provided by (Responsible Party): Siayareh Rambally, University of Texas Southwestern Medical Center

Tracking Information

• First Submitted Date: September 19, 2022
• First Posted Date: October 7, 2022
• Last Update Posted Date: February 13, 2023
• Actual Study Start Date: November 10, 2022
• Actual Primary Completion Date: February 2, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 26, 2022)

• 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 [ 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.
• 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.
• 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 ]

Original Primary Outcome Measures (submitted: October 5, 2022)

• 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 [ 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.
• 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.
• 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 each video completed [ Time Frame: at the time of hospital discharge, up to 6 months post-intervention ]

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Mindfulness and Yoga Therapy for Acute Pain in Sickle Cell Disease
• Official Title: Mindfulness and Yoga Therapy for Acute Pain in Sickle Cell Disease
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Sickle Cell Crisis
• Sickle Cell Disease

Intervention

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.

Study Arms

Experimental: Mindfulness and Yoga Therapy

Participants will have access to video-guided mindfulness interventions.

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 9, 2023): 39
• Original Estimated Enrollment (submitted: October 5, 2022): 50
• Actual Study Completion Date: February 2, 2023
• Actual Primary Completion Date: February 2, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05572294
• Other Study ID Numbers: STU-2021-0729
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Siayareh Rambally, University of Texas Southwestern Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Texas Southwestern Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Siayareh Rambally, M.D.; University of Texas Southwestern Medical Center

• PRS Account: University of Texas Southwestern Medical Center
• Verification Date: February 2023