Effects of Mindfulness Meditation Training on Anxiety and Sleep Quality of Patients With Hematopoietic Stem Cell Transplantation During Admission in the Laminar Flow Chamber
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Effect of the mindfulness meditation practice on the PSQI
研究概览
简要总结
In recent years, it has been widely observed that patients undergoing hematopoietic stem cell transplantation often experience elevated anxiety levels and a decline in sleep quality during their stay in the laminar flow chamber. Existing psychological support measures have proven insufficient in addressing their specific needs. Consequently, there is a pressing need to explore safe, non-pharmacological interventions suitable for this isolated clinical environment.
详细描述
In China, hematologic malignancies account for approximately 4.5% of all newly diagnosed cancers and 4.8% of cancer - related deaths. According to the 2022 National Cancer Report released by the National Cancer Center, a total of about 117,000 new cases of leukemia, lymphoma, and multiple myeloma were documented worldwide in 2022.
Hematopoietic stem cell transplantation (HSCT) has emerged as a critical therapeutic intervention for hematological malignancies and blood disorders. Patients require strict isolation in class 100 laminar airflow chambers to prevent opportunistic infections. The duration of protective isolation typically ranges from 20 to 30 days, depending on the transplant type.
Current research reveals that this necessary isolation protocol has significant psychological consequences. Approximately 58 - 72% of HSCT patients confined to sterile environments develop clinically significant anxiety and depression, mainly due to treatment - related distress and concerns about disease prognosis. These psychological comorbidities often manifest as sleep architecture disturbances. In severe cases (12 - 18% incidence), they progress to post - traumatic stress disorder (PTSD). Sleep disruption, driven by circadian misalignment, cortisol dysregulation, and rumination, compounds immune suppression and jeopardizes graft success. Therefore, the study focused on these psychological problems to improve the quality of life for patients undergoing HSCT during their stay in the Laminar Flow unit.
Mindfulness meditation is a cognitive-behavioral practice that enhances self-regulatory capacity through attentional control and emotional regulation, promoting psychophysiological homeostasis characterized by mental calmness and focused awareness. This non-invasive intervention demonstrates operational feasibility with minimal implementation barriers, owing to its non-pharmacological nature, absence of documented adverse effects, and cost-effectiveness. It improves both affective and sleep outcomes in diverse oncology populations.
In addition, in a single-arm study of 52 allogeneic hematopoietic stem cell transplantation recipients, a 15 - minute audio-guided mindfulness protocol was first piloted within laminar-airflow isolation rooms. By day +21, HADS-A scores had fallen by 3.2 points and nocturnal high-frequency HRV power rose by 21%, indicating restored parasympathetic tone.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years
- •Volunteered to join the study
排除标准
- •Patients with secondary transplantation
- •Patients with other critical illness, such as malignancy, cardiac failure, renal failure, respiratory failure, severe traum
- •Patients with mental illness or psychotherapy before admission
研究组 & 干预措施
control group
Provide routine health education and transplant care before and after admission. During pretreatment, as blood cell counts drop, offer oral, skin, and perianal care. Guide hand hygiene throughout to prevent infection. During stem cell transfusion, monitor vital signs closely. During recovery, guide patients on safety, rest, and activity. Explain HSCT-related knowledge and provide psychological and social support.
干预措施: Mindfulness Meditation Training (Behavioral)
Intervention group
Meditation training included two stages. Stage 1: 7-Day Course Goal: Build trust, explain the study, and teach meditation. Body Relaxation (5 min): Patients closed eyes and relaxed from head to toes, guided by a qualified intervener.
Breathing Adjustment (5 min): Patients focused on slow breaths and abdominal movement; if distracted, they refocused calmly.
Attention Focus (20 min): Patients imagined recovery scenes, like post-transplant renewal, guided by vivid descriptions.
Stage 2: 21-Day Self-Practice (Days 1-21 post-transplant) Patients meditated daily for one hour before sleep, guided by soothing music, and kept a log.
Nursing staff recorded sessions, addressed issues, and tracked progress.
干预措施: Mindfulness Meditation Training (Behavioral)
结局指标
主要结局
Effect of the mindfulness meditation practice on the PSQI
时间窗: Day 1; Up to 4 weeks
· Before and after the intervention, the Pittsburgh Sleep Quality Index Scale (PSQI) was used to measure the two groups. Each component was weighted equally on a 0 to 3 scale and summed to provide a one-factor global PSQI score ranging from 0 (no sleep problems) to 21 (severe sleep problems) with scores \> 5 considered indicative of 'problem sleep' according to the original validation and scoring reference
次要结局
- Effect of the mindfulness meditation practice on the SAS(Day 1; Up to 4 weeks)
研究者
Fangli Liu ,MD
Principal Investigator
Henan University
