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

NCT07462962 | Completed

• 1 other identifier: HUSOM2026-079
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hematopoietic Stem Cell Transplantation (HSCT); Cancer and / or Hematological Malignancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Effect of the mindfulness meditation practice on the SAS

  Day 1; Up to 4 weeks

Study Arms (2)

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

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

Interventions

Mindfulness Meditation Training BEHAVIORAL

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; control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henan University: lead

Study Sites (1)

Henan University

Kaifeng, Henan, China

Location

MeSH Terms

Conditions

Neoplasms; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 10, 2026
• Study Start: March 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)