Effect of a Simplified Mindfulness Intervention on Health-related Quality of Life in Patients Undergoing Hematopoietic Stem Cell Transplantation: A Prospective Single-Center Randomized Controlled Trial

NCT ID: NCT07127562

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 148 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-07
• Study Completion Date: 2027-06-30

Brief Summary

This study aims to evaluate the impact of a simplified mindfulness intervention (daily mindfulness breathing and body scanning) during hospitalization in the transplant ward on health-related quality of life in hematopoietic stem cell transplantation patients.

Detailed Description

All patients undergo standardized HSCT treatment, which does not interfere with the management of their underlying conditions. Patients are randomly assigned to either the 'Mindfulness Intervention Group' or the 'Conventional Support Group' based on age (whether over 40) and transplant type (autologous or allogeneic), in a 1:1 ratio. The study period is at least 21 days, during which patients are hospitalized in the transplant ward.

Conditions

Hematopoietic Stem Cell Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Mindfulness intervention group

1. Mindfulness intervention group: Intermittent period: from the first day to at least the 21st day, and up to the 28th day, continuous implementation

Content of intervention (daily completion):

1. Mindfulness breathing exercise (10 minutes) Content: Close your eyes to perceive the breath coming in and out, pay attention to the present moment, without judgment; Tools: Chinese voice-guided audio (nurses check room or patients scan code to play); Time: to be completed between 9am and 10am;

2. Body Scan Exercise (15 minutes) Content: gradually perceive the tension, pain or relaxation of each part of the body from head to toe; Tools: Chinese audio guidance, which can be played during the infusion or before going to bed; Time: between 7-8pm;

Group Type: EXPERIMENTAL

Mindfulness intervention

Intervention Type: BEHAVIORAL

Intermittent period: from the first day to at least the 21st day, and up to the 28th day, continuous implementation

Content of intervention (daily completion):

1. Mindfulness breathing exercise (10 minutes) Content: Close your eyes to perceive the breath coming in and out, pay attention to the present moment, without judgment; Tools: Chinese voice-guided audio (nurses check room or patients scan code to play); Time: to be completed between 9am and 10am;

2. Body Scan Exercise (15 minutes) Content: gradually perceive the tension, pain or relaxation of each part of the body from head to toe; Tools: Chinese audio guidance, which can be played during the infusion or before going to bed; Time: between 7-8pm;

Conventional support group

received conventional nursing and rehabilitation guidance, but did not receive mindfulness intervention. The control group patients received conventional hospital nursing services during the study period, including disease monitoring, drug treatment, rehabilitation guidance, etc., but did not receive any form of mindfulness training or other similar psychological interventions.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness intervention

Intermittent period: from the first day to at least the 21st day, and up to the 28th day, continuous implementation

Content of intervention (daily completion):

1. Mindfulness breathing exercise (10 minutes) Content: Close your eyes to perceive the breath coming in and out, pay attention to the present moment, without judgment; Tools: Chinese voice-guided audio (nurses check room or patients scan code to play); Time: to be completed between 9am and 10am;

2. Body Scan Exercise (15 minutes) Content: gradually perceive the tension, pain or relaxation of each part of the body from head to toe; Tools: Chinese audio guidance, which can be played during the infusion or before going to bed; Time: between 7-8pm;

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Aged 18 years or older.

2. Scheduled to receive either autologous or allogeneic HSCT.

3. Anticipated inpatient stay in the transplant unit of at least 21 days.

Exclusion Criteria

1. Prior history of hematopoietic stem cell transplantation (HSCT).

2. Active psychiatric disorder or cognitive impairment.

3. Systematic training in mindfulness/mindfulness-based interventions/yoga within the past 3 months.

4. Contraindications to MRI.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

erlie jiang, doctor

Role: CONTACT

jiangerlie@ihcams.ac.cn

02223608600

Other Identifiers

IIT2025078

Identifier Type: -

Identifier Source: org_study_id