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.

Study Overview

• Status: Completed
• Conditions: Sickle Cell Disease; Sickle Cell Crisis
• Intervention / Treatment: Behavioral: Mindfulness meditation, breathing exercises (including incentive spirometry), and yoga therapy

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
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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		12 weeks
Feasibility of the intervention as measured by the proportion of participants who accessed the mindfulness videos during their hospitalization		12 weeks
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.	at the time of hospital discharge, up to 6 months post-intervention
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.	at the time of hospital discharge, up to 6 months post-intervention
Participant engagement as measured by the number of mindfulness videos watched by each participant during their hospitalization		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.		at the time of hospital discharge, up to 6 months post-intervention

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 10, 2022
• Primary Completion (ACTUAL): February 2, 2023
• Study Completion (ACTUAL): February 2, 2023

Study Registration Dates

• First Submitted: September 19, 2022
• First Submitted That Met QC Criteria: October 5, 2022
• First Posted (ACTUAL): October 7, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 13, 2023
• Last Update Submitted That Met QC Criteria: February 9, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Mindfulness; Sickle Cell Disease; Yoga Therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Acute Pain; Anemia, Sickle Cell
• Other Study ID Numbers: STU-2021-0729

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No