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

Institute of Hematology & Blood Diseases Hospital, China

Status: Not yet enrolling

Conditions: Hematopoietic Stem Cell Transplantation

Treatments: Behavioral: Mindfulness intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07127562

IIT2025078

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

Mindfulness intervention group

Experimental group

Description:

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;

Treatment:

Behavioral: Mindfulness intervention

Conventional support group

No Intervention group

Description:

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.