Mindfulness and Yoga Therapy for Acute Pain in Sickle Cell Disease

NCT ID: NCT05572294

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-10
• Study Completion Date: 2023-02-02

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.

Conditions

Sickle Cell Crisis; Sickle Cell Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Mindfulness and Yoga Therapy

Participants will have access to video-guided mindfulness interventions.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Siayareh Rambally

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Siayareh Rambally, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

STU-2021-0729

Identifier Type: -

Identifier Source: org_study_id