Henan University
Kaifeng, Henan, China
NCT Number: NCT07462962
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.
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Observational
Kaifeng, Henan, China
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.
A subsequent feasibility trial (n = 60) confirmed that four sessions of online mindfulness-based stress reduction (MBSR) were well accepted in autologous HSCT patients (completion rate 88%), yielding a 2.4 - point improvement in the PSQI total score. No adverse events were reported. For cancer patients, mindfulness intervention can not only effectively improve their mental health and quality of life.
Notwithstanding these well - established benefits, the therapeutic utility of MBIs in HSCT recipients remains underexplored, particularly in terms of anxiety modulation and sleep quality improvement during protective isolation. To address this evidence gap, the investigator implemented a structured mindfulness meditation protocol for HSCT patients, with the dual primary endpoints of anxiety and sleep quality.
This study therefore aims to test the hypothesis that a mindfulness meditation intervention can effectively reduce anxiety - related symptoms and improve sleep quality in patients undergoing HSCT during their hospitalization in the laminar flow chamber. Specifically, the investigator will evaluate its efficacy in decreasing state anxiety and enhancing perceived sleep quality throughout this critical period. By examining these outcomes, this research seeks to provide an evidence - based psychological support strategy, ultimately empowering HSCT patients to better manage in - hospital distress and improve their overall well - being.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 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
Time frame: Day 1; Up to 4 weeks
Before and after the intervention, the Zung Self - rating Anxiety Scale (SAS) was used to measure the two groups.
It was comprised of 20 items rated on a 4 - point Likert scale (1 = rarely to 4 = always), generating total scores ranging from 20 to 80.
Henan University
Other
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