Mindfulness and Yoga Therapy for Acute Pain in Sickle Cell Disease

NCT05572294 | Completed

• 1 other identifier: STU-2021-0729
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Crisis; Sickle Cell Disease

Keywords

Sickle Cell Disease; Yoga Therapy; Mindfulness

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Mindfulness and Yoga Therapy

EXPERIMENTAL

Participants will have access to video-guided mindfulness interventions.

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

Interventions

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.

Mindfulness and Yoga Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to follow simple instructions
• Admitted to the intensive care unit

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Vaso-Occlusive Crises; Anemia, Sickle Cell

Interventions

Mindfulness; Breathing Exercises; Yoga

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities; Spiritual Therapies

Study Officials

• Siayareh Rambally, M.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: October 7, 2022
• Study Start: November 10, 2022
• Primary Completion: February 2, 2023
• Study Completion: February 2, 2023
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)