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临床试验/NCT07462962
NCT07462962已完成不适用

Effects of Mindfulness Meditation Training on Anxiety and Sleep Quality of Patients With Hematopoietic Stem Cell Transplantation During Admission in the Laminar Flow Chamber

Henan University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年3月1日最近更新:
干预措施

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

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

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

Fangli Liu ,MD

Principal Investigator

Henan University

研究点 (1)

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