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

NCT06792630 | Not Yet Recruiting

• 1 other identifier: QTJC2024057
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

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. 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. 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。

Conditions

Hematologic Malignancy; Hematopoietic Stem Cell Transplant

Outcome Measures

Primary Outcomes (3)

• Overall survival

  time between the start of randomization and death from any cause

  3 months, 6 months, and 1 year

• Progression-free survival

  time between the start of randomization and progression of the tumor in any respect or death from any cause

  3 months, 6 months, and 1 year

• Time to treatment failure

  time from start of randomization to withdrawal from the trial, withdrawal may be due to patient refusal, disease progression, death, adverse events

  3 months, 6 months, and 1 year

Study Arms (2)

Intervention group

EXPERIMENTAL

In addition, patients in the intervention group were given laughter therapy intervention from the 1st day of HSCT, with the mnemonic "hihihi (pinyin spelling), hahahaha, eggplant eggplant eggplant, qixi qixi qixi qixi, hahahahahahahahaha," 30 times of the mnemonic as a training session, once a day, from the beginning of the transplantation transfusion +1d to the end of the transplantation transfusion +1d, and then to the end of the transplantation. Patients were discharged from the warehouse, and after discharge, patients were centralized on-line laughter therapy intervention, 1 time/week, repeating 30 times of mnemonics, until 1 year after transplantation.

Behavioral: laughter therapy intervention

Control group

NO INTERVENTION

atients in the intervention group and the control group were given standard therapeutic measures as well as routine care during hospitalization and after discharge in accordance with the recommendations of the appropriate treatment guidelines. The control group used routine nursing education and continuity of care after discharge.

Interventions

laughter therapy intervention BEHAVIORAL

In addition, patients in the intervention group were given laughter therapy intervention from the 1st day of HSCT, with the mnemonic "hihihi (pinyin spelling), hahahaha, eggplant eggplant eggplant, qixi qixi qixi qixi, hahahahahahahahaha," 30 times of the mnemonic as a training session, once a day, from the beginning of the transplantation transfusion +1d to the end of the transplantation transfusion +1d, and then to the end of the transplantation. Patients were discharged from the warehouse, and after discharge, patients were centralized on-line laughter therapy intervention, 1 time/week, repeating 30 times of mnemonics, until 1 year after transplantation.

Intervention group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: January 24, 2025
• Study Start: January 31, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: January 24, 2025

Record last verified: 2024-12