A Study of the Effect of Laughter Therapy on the Mental Health and Quality of Survival of Hematopoietic Stem Cell Transplant Patients

Not Applicable

Not yet recruiting

• Conditions: Hematologic Malignancy; Hematopoietic Stem Cell Transplant

• Registration Number: NCT06792630
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Brief Summary

主要研究目的：

1)探讨笑疗法在造血干细胞移植患者移植心理健康及生存质量中的效果。 次要研究目的：

1. 了解造血干细胞移植患者移植后3个月、6个月、1年内的心理健康变化和生存质量水平；

2. 探讨笑疗法在造血干细胞移植患者预后等结局指标中的应用效果。

Detailed Description

本研究将采用单中心、前瞻性的平行随机对照试验对2024年12月1日至2025年12月1日期间首次接受造血干细胞移植的患者进行招募。对照组实施常规护理措施和出院的常规延续护理措施，干预组从移植+1天开始进行笑治疗，住院期间为移植后+1天至出仓，按照笑的口令"hihihi（拼音拼读），哈哈哈，茄子茄子茄子，七喜七喜七喜，哈哈哈哈哈哈"，30遍口令为1次训练，1天进行1次。出仓及出院后，干预组患者集中线上笑疗法干预，1次/周，重复30遍口令，至移植后1年。分别于移植后3个月、6个月、1年对两组患者在预后、疲劳、焦虑及抑郁、幸福感以及创伤后成长、生存质量及结局指标上进行组间比较，明确笑疗法在造血干细胞移植患者心理健康及生存质量中的效果。

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-27
• Study First Submitted QC: 2025-01-21
• Last Update Submitted: 2025-01-21
• Study First Posted: 2025-01-24
• Last Update Posted: 2025-01-24
• Study Start: 2025-01-31
• Primary Completion: 2026-11-30
• Study Completion: 2026-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Patients with a pathologically confirmed diagnosis of hematologic malignancy; Patients undergoing their first hematopoietic stem cell transplant; Age ≥ 16 years; Those who have some reading and writing ability; Those who can cooperate in completing the questionnaires and assessments; Informed consent and voluntary participation in the study.

Exclusion Criteria

Those with severe mental illness or personality disorders; Those who cannot operate a smartphone independently; Those with severe visual and hearing impairments; Those who are critically ill and cannot receive the intervention.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall survival	3 months, 6 months, and 1 year	time between the start of randomization and death from any cause
Progression-free survival	3 months, 6 months, and 1 year	time between the start of randomization and progression of the tumor in any respect or death from any cause
Time to treatment failure	3 months, 6 months, and 1 year	time from start of randomization to withdrawal from the trial, withdrawal may be due to patient refusal, disease progression, death, adverse events