Humor Therapy and Distress After Allogeneic Stem Cell Transplantation

Universitätsklinikum Hamburg-Eppendorf

Status: Unknown

Conditions: Allogeneic Hematopoietic Stem Cell Transplantation

Treatments: Behavioral: Humor therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03593161

DJCLS 26R/2017

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Admission for allogeneic transplantation at the University Medical Center Hamburg-Eppendorf

Exclusion criteria

• Insufficient German language skills

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Humor therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Humor therapy

Treatment as usual

No Intervention group

Description:

Patients assigned to the control arm will receive the standard psychosocial care over the course of their inpatient stay for allogeneic stem cell transplantation.