The Effect of Mindfulness_Based Intervention on Sleep Quality, Emotional Symptoms, and Emotion Regulation Among Saudi Patients Receiving Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index
研究概览
简要总结
This study aims to evaluate whether an MBI improves sleep quality, emotional symptoms (depression, anxiety, stress), emotion regulation, and trait mindfulness among adults with ESRD on HD. A randomized two-arm pre-post design was conducted with N = 38 patients at Dr. Soliman Fakeeh Hospital (DSFH), Saudi Arabia (n = 19 intervention; n = 19 control). The intervention comprised 30-minute guided sessions, 3 times a week for 5 weeks during HD sessions. The control group received the study intervention after the study. Outcomes were assessed at baseline and post-intervention using the Pittsburgh Sleep Quality Index (PSQI), Depression Anxiety Stress Scale-21 (DASS-21), Emotion Regulation Questionnaire (ERQ), and Mindful Attention Awareness Scale (MAAS).
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being aged 18 or above
- •having a history of maintenance dialysis for three months
- •having the capacity to self-report
排除标准
- •Having acute psychiatric illness or substantial cognitive dysfunction
- •Involving in frequent meditation or yoga practice.
研究组 & 干预措施
Mindfulness-based Intervention
The intervention was a structured audio-based MBI program over a five-week period during regular hemodialysis procedure. The program, delivered using validated audio recordings, drew on the principles of mindfulness-based stress reduction (MBSR) and was tailored to the needs of hemodialysis patients. The intervention group participated in daily 30-minute sessions of guided MBI three times a week for five weeks. These sessions took place during the dialysis sessions to improve the feasibility and avoid placing further burdens on participants. The mindfulness intervention involved a number of key elements, such as focusing on the breathing, body scanning, awareness of the present moment and nonreactive monitoring of thoughts and feelings. Participants were advised to become mindful of their thoughts, feelings, and sensations, without trying to change them. The program also taught acceptance-based approaches and cognitive diffusion from negative thoughts.
干预措施: Mindfulness-Based Intervention (Behavioral)
Control Group
The control arm participants received no additional psychological or behavioural intervention during the trial
结局指标
主要结局
Pittsburgh Sleep Quality Index
时间窗: From enrollment to the end of intervention at 5 weeks
It is used to gain a broad understanding of sleep architecture over the previous 30 days. This 19-item self-report questionnaire assesses seven components of sleep: sleep quality; sleep latency (time to fall asleep); sleep duration; sleep efficiency (time asleep, relative to total time in bed); sleep disturbances; use of sleeping medication; and daytime dysfunction (Buysse et al., 1989). The score for each component ranges from 0 to 3. Added together, the scores of the seven components produce a Global Sleep Quality Score, ranging from 0 to 21.
Depression, Anxiety, and Stress Scale (DASS-21)
时间窗: From enrollment to the end of intervention at 5 weeks
The DASS-21 was used to assess the psychological distress of having end-stage renal disease. This scale includes three 7-item subscales that distinguish between the key elements of depression (e.g., dysphoria, hopelessness), anxiety (e.g., autonomic arousal, skeletal muscle effects) and stress (e.g., irritability, impatience). Respondents are asked to respond on a 4-point Likert scale according to how they have felt in the last week. As a shortened form of the original 42-item DASS, the scores of each of the three DASS-21 subscales are doubled to reflect ratings for the standard severity levels (from "Normal" to "Extremely Severe")
次要结局
- The Emotion Regulation Questionnaire (ERQ)(From enrollment to the end of intervention at 5 weeks)
- Mindful Attention Awareness Scale (MAAS)(From enrollment to the end of intervention at 5 weeks)
研究者
Hossam Najjem Alhawatmeh
Associate Professor
Jordan University of Science and Technology