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Mindfulness and Yoga Therapy for Acute Pain in Sickle Cell Disease

Primary Purpose

Sickle Cell Crisis, Sickle Cell Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness meditation, breathing exercises (including incentive spirometry), and yoga therapy
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sickle Cell Crisis focused on measuring Sickle Cell Disease, Yoga Therapy, Mindfulness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mindfulness and Yoga Therapy

Arm Description

Participants will have access to video-guided mindfulness interventions.

Outcomes

Primary Outcome Measures

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
Feasibility of the intervention as measured by the proportion of participants who accessed the mindfulness videos during their hospitalization
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.
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.
Participant engagement as measured by the number of mindfulness videos watched by each participant during their hospitalization
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.

Secondary Outcome Measures

Full Information

First Posted
September 19, 2022
Last Updated
February 9, 2023
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05572294
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 10, 2022 (Actual)
Primary Completion Date
February 2, 2023 (Actual)
Study Completion Date
February 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Crisis, Sickle Cell Disease
Keywords
Sickle Cell Disease, Yoga Therapy, Mindfulness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness and Yoga Therapy
Arm Type
Experimental
Arm Description
Participants will have access to video-guided mindfulness interventions.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness meditation, breathing exercises (including incentive spirometry), and yoga therapy
Intervention Description
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 Outcome Measure Information:
Title
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
Title
Feasibility of the intervention as measured by the proportion of participants who accessed the mindfulness videos during their hospitalization
Time Frame
12 weeks
Title
Acceptability of the intervention as measured by the proportion of participants who found the mindfulness practices enjoyable and/or helpful
Description
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.
Time Frame
at the time of hospital discharge, up to 6 months post-intervention
Title
Acceptability of the intervention as measured by the proportion of participants who are interested in pursuing mindfulness therapies in the future
Description
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.
Time Frame
at the time of hospital discharge, up to 6 months post-intervention
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Siayareh Rambally, M.D.
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Mindfulness and Yoga Therapy for Acute Pain in Sickle Cell Disease

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