The Effect of Humor Therapy on Perceived Distress After Allogeneic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Distress
研究概览
简要总结
This research study evaluates the impact of a humor intervention on distress (primary outcome), hope, depressive symptoms, anxiety, and pain (secondary outcomes) in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).
详细描述
Patients undergoing allo-HSCT often experience substantial psychological distress during hospitalization and after discharge. Research in pediatric patients with cancer as well as geriatric patients suggests that psychosocial burden might be decreased by humor therapy. Studies addressing the impact of humor therapy in adult patients with cancer are lacking.
This randomized controlled trial primarily aims at assessing the effect of therapeutic humor on global distress in patients during their hospital stay for allo-HSCT. In addition, the study investigates hope, depressive symptoms, anxiety, and pain as secondary outcomes. The outcomes are measured via questionnaires.
Study results may be beneficial for patients who experience distress during hospitalization for allo-HSCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Admission for allogeneic transplantation at the University Medical Center Hamburg-Eppendorf
排除标准
- •Insufficient German language skills
研究组 & 干预措施
Humor therapy
After baseline assessment (before start of conditioning), patients assigned to the experimental study arm will receive the standard psychosocial care plus weekly clown visits over the course of their inpatient stay for allogeneic stem cell transplantation.
干预措施: Humor therapy (Behavioral)
Treatment as usual
Patients assigned to the control arm will receive the standard psychosocial care over the course of their inpatient stay for allogeneic stem cell transplantation.
结局指标
主要结局
Distress
时间窗: Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +7, +14, +21 and +28)
Measured with the Distress Thermometer (DT): Brief screening instrument to assess the level of perceived distress in patients with cancer (11-point scale ranging from 0 = no distress to 10 = extreme distress)
次要结局
- Hope(Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +7, +14, +21 and +28))
- Anxiety symptoms(Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +14 and +28))
- Pain intensity measured with the Numerical Rating Scale (NRS)(Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +7, +14, +21 and +28))
- Depressive symptoms(Change from baseline (before start of conditioning) to 4 weeks after allogeneic stem cell transplantation (days +14 and +28))