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临床试验/NCT05572294
NCT05572294已完成不适用

Mindfulness and Yoga Therapy for Acute Pain in Sickle Cell Disease

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2022年11月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
39
试验地点
2
主要终点
Feasibility of the intervention as measured by the proportion of participants who accessed the mindfulness videos during their hospitalization

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Feasibility of the intervention as measured by the proportion of participants who accessed the mindfulness videos during their hospitalization

时间窗: 12 weeks

Acceptability of the intervention as measured by the proportion of participants who found the mindfulness practices enjoyable and/or helpful

时间窗: 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

时间窗: 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.

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

时间窗: 12 weeks

Participant engagement as measured by the number of mindfulness videos watched by each participant during their hospitalization

时间窗: 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.

时间窗: at the time of hospital discharge, up to 6 months post-intervention

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Siayareh Rambally

Associate Professor

University of Texas Southwestern Medical Center

研究点 (2)

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