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临床试验/NCT07271706
NCT07271706尚未招募不适用

The Effect of Laughter Yoga on Self-management and Comfort in Type 2 Diabetes Patients

Bozok University0 个研究点目标入组 80 人开始时间: 2025年12月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
主要终点
Diabetes Self-Management Score (Diabetes Self-Management Questionnaire - DSMQ)

研究概览

简要总结

The purpose of this study is to examine the effect of laughter yoga on self-management skills and comfort levels in patients with Type 2 diabetes.

详细描述

Diabetes is a major global health problem affecting more than 537 million adults worldwide, a number expected to rise substantially in the coming decades. Type 2 diabetes, the most prevalent form, requires consistent self-management to maintain glycemic control and prevent complications. However, individuals living with chronic illness often experience ongoing physiological fatigue and emotional stress, which can reduce self-efficacy and hinder engagement in self-management behaviors. Comfort, identified as an important psychological resource, plays a supportive role in sustaining these behaviors.

Katharine Kolcaba's Comfort Theory proposes that health behaviors can be positively influenced by enhancing individuals' physical, psychospiritual, sociocultural, and environmental comfort. Laughter Yoga-a mind-body intervention combining intentional laughter with breathing and relaxation techniques-has been shown to reduce stress, improve mood, and increase parasympathetic activity. Previous studies involving individuals with Type 2 diabetes have reported reductions in HbA1c, decreased stress levels, and improved quality of life following Laughter Yoga interventions. However, limited research has simultaneously examined its effects on both self-management behaviors and comfort levels.

This study aims to evaluate the effects of Laughter Yoga on self-management behaviors and comfort levels among individuals with Type 2 diabetes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

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

入选标准

  • Diagnosis of Type 2 diabetes
  • Age 18 years or older
  • Willingness to participate in the Laughter Yoga intervention
  • Ability to read and comprehend Turkish

排除标准

  • Diagnosis of Type 1 diabetes
  • Participation in individual psychotherapy or group-based psychological intervention programs
  • Experience of a recent loss within the past month (e.g., death, divorce)
  • Presence of any psychiatric diagnosis
  • Use of psychiatric medication
  • Severe visual or hearing impairment preventing active participation in the intervention
  • Pregnancy or breastfeeding
  • Limitations in reading or comprehending Turkish

结局指标

主要结局

Diabetes Self-Management Score (Diabetes Self-Management Questionnaire - DSMQ)

时间窗: Baseline (Day 0) and Week 4

The Diabetes Self-Management Questionnaire (DSMQ), originally developed by Schmitt et al. (2013), will be used to evaluate diabetes self-management behaviors. The DSMQ consists of 16 items and four subscales: Glucose Management Dietary Control Physical Activity Health-Care Use Items are rated on a 4-point Likert scale (0-3). Seven items are scored positively, and nine items are reverse-scored. Total scores are calculated by dividing the raw score by the maximum possible score and multiplying by 10. The resulting values range from 0 to 10, with higher scores indicating better diabetes self-management.

Comfort Level Score (General Comfort Questionnaire - Short Form)

时间窗: Baseline (Day 0) and Week 4

The General Comfort Questionnaire - Short Form, developed by Kolcaba (2006), will be used to assess comfort levels across physical, psychospiritual, environmental, and social domains. The scale consists of 28 items and three subscales: Relief Ease Transcendence Items are rated on a 6-point Likert scale (1-6). Negative items are reverse-scored. The total comfort score ranges from 1 to 6, with higher scores indicating greater comfort.

次要结局

未报告次要终点

研究者

发起方
Bozok University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Betül Bal

Lecturer Doctor

Bozok University

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