Examining the Influence of Guided Meditation on Diabetes-related Distress and Glycemic Control: A Randomized Controlled Trial Among Hospitalized Type 1 Adolescent Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Diabetes distress scale
研究概览
简要总结
The study aims to investigate the effects of Guided Meditation on diabetes-related distress and glycemic control in hospitalized Type 1 adolescent diabetic patients. The study will employ a randomized controlled trial design, with participants randomly assigned to either the intervention group (receiving Guided Meditation sessions) or the control group (receiving standard care). The primary outcomes measured will be diabetes-related distress levels and glycemic control (HbA1c levels).
详细描述
The researchers hypothesize that the intervention group will experience a reduction in diabetes-related distress and an improvement in glycemic control compared to the control group. The study's findings could suggest how guided meditation could help manage the emotional distress and enhance diabetes management in hospitalized Type 1 adolescent diabetic patients.
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 (Outcomes Assessor)
盲法说明
Outcomes assessor did not know which patients received the intervention and which patients did not
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescent patients aged between 12 to 18 years.
- •Confirmed diagnosis of Type 1 diabetes mellitus.
- •Hospitalized in the participating medical facility.
- •Capable of providing informed consent (for participants aged 18) or providing assent with parental/legal guardian consent (for participants aged 12 to 17).
排除标准
- •Presence of severe psychiatric disorders or cognitive impairments that may hinder participation in the guided meditation sessions.
- •Physical limitations or medical conditions that prevent the safe participation in the intervention or assessment procedures.
- •Previously engaged in regular meditation or mindfulness practices, which may confound the results.
- •Inability to communicate effectively in the language used for assessments and interventions.
结局指标
主要结局
Diabetes distress scale
时间窗: Week 1 and Week 13
Diabetes distress scale questionnaire
次要结局
- HbA1c levels(Week 1 and Week 13)
- Number of hypoglycemic and hyperglycemic episodes(Week 1, 4, 8 and 12)
研究者
Saima Abass Tahammal
Principal Investigator
Shifa International Hospital