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

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.

Study Overview

• Status: Completed
• Conditions: Hematopoietic Stem Cell Transplantation (HSCT); Cancer and / or Hematological Malignancy
• Intervention / Treatment: Behavioral: Mindfulness Meditation Training

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• China
  • Henan
    • Kaifeng, Henan, China
      • Henan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

(1) Patients with secondary transplantation, (2) Patients with other critical illness, such as malignancy, cardiac failure, renal failure, respiratory failure, severe traum, (3) patients with mental illness or psychotherapy before admission.

Description

Inclusion Criteria:

• Age 18 years
• HSCT
• Volunteered to join the study

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Behavioral: Mindfulness Meditation Training; 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
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.	Behavioral: Mindfulness Meditation Training; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of the mindfulness meditation practice on the PSQI	· 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	Day 1; Up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of the mindfulness meditation practice on the SAS	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.	Day 1; Up to 4 weeks

Collaborators and Investigators

• Sponsor: Henan University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Actual): June 1, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 6, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: HUSOM2026-079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No