A Study of the Effect of Laughter Therapy on the Mental Health and Quality of Survival of Hematopoietic Stem Cell Transplant Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 98
- 主要终点
- Overall survival
研究概览
简要总结
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：
- 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；
- 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。
详细描述
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。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention group
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.
干预措施: laughter therapy intervention (Behavioral)
Control group
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.
结局指标
主要结局
Overall survival
时间窗: 3 months, 6 months, and 1 year
time between the start of randomization and death from any cause
Progression-free survival
时间窗: 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
时间窗: 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
次要结局
未报告次要终点