Hematopoietic Stem Cell Transplantation (HSCT)NCT07462962
Effects of Mindfulness Meditation Training on Anxiety and Sleep Quality of Patients With Hematopoietic Stem Cell Transplantation During Admission in the Laminar Flow Chamber
An observational study of Hematopoietic Stem Cell Transplantation (HSCT) and Cancer and / or Hematological Malignancy, run by Henan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation (HSCT), Cancer and / or Hematological Malignancy
- What is being tested?
- Mindfulness Meditation Training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Age 18 years
- HSCT
- Volunteered to join the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Mindfulness Meditation Training
- Medical subject headings
- Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Meditation TrainingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mindfulness Meditation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1; Up to 4 weeks
Secondary outcomes (1)
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.
Measured: Day 1; Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Mar 2025
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell Transplantation (HSCT)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fangli Liu ,MD, Henan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462962
- Sponsor's protocol ID
- HUSOM2026-079
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mindfulness Meditation Training on Anxiety and Sleep Quality of Patients With Hematopoietic Stem Cell Transplantation During Admission in the Laminar Flow Chamber
- ClinicalTrials.gov ID
- NCT07462962
- Acronym / sponsor ID
- HUSOM2026-079
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Henan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | Behavioral: Mindfulness Meditation TrainingProvide 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. |
| Intervention group | – | Behavioral: Mindfulness Meditation TrainingMeditation 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age 18 years
- HSCT
- Volunteered to join the study
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Meditation TrainingMindfulness 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 | Behavioural | Intervention group, control group |
Primary outcome
Effect of the mindfulness meditation practice on the PSQI
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
1 secondary outcome
Effect of the mindfulness meditation practice on the SAS
Time frame: Day 1; Up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Hematopoietic Stem Cell Transplantation (HSCT)
Not yet recruiting
Impact of Closed PBSC Collection With Reduced Gas-Phase Oxygen Exposure on Graft Quality and Early Engraftment in Allo-HSCT
Allogeneic Hematopoietic Stem Cell Transplantation (HSCT), Oxygen Deficiency
Recruiting
Comprehensive Palliative Care After Stem Cell Transplantation: a Feasability Study
Hematopoietic Stem Cell Transplantation (HSCT)
Not yet recruiting
Nutritional Intervention for Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Hematopoietic Stem Cell Transplantation (HSCT), Malnutrition (Calorie)
RecruitingObservational study
Cardiovascular Complications in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation.
Cardiotoxicity, DPP3
Not yet recruiting
Effect of a Standardized Oral Care Program on Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation: A Randomized Controlled Trial(SOC-HSCT)
Oral Mucositis, Hematopoietic Stem Cell Transplantation (HSCT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic Stem Cell Transplantation (HSCT) and Cancer and / or Hematological Malignancy, run by Henan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of the mindfulness meditation practice on the PSQI (time frame: Day 1; Up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.