Clinical trial NCT06919588: Effects of Comedy Therapy on Anxiety and Vital Signs in Transplant Recipients
Official title: Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplant; Complications
Stress
Care Acceptor, Health
Keywords: stress
vital signs
pre-operative
liver
transplant
comedy films
Lead sponsor: Bitlis Eren University
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: It will be conducted as a randomized controlled experimental study in a pretestpost- test control group experimental model.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was conducted to investigate the effects of watching excerpts from classical Turkish comedy films on pre-transplant anxiety levels and vital signs in liver transplant recipients.

H1-0: Watching classical Turkish comedy films has no effect on preoperative anxiety in liver transplant recipients.

H1-1: Watching classical Turkish comedy films reduces preoperative anxiety in liver transplant recipients.

H2-0: Watching classical Turkish comedy films has no effect on preoperative vital signs in liver transplant recipients.

H2-1: Watching classical Turkish comedy films has a positive effect on preoperative vital signs in liver transplant recipients.

Detailed description: Intervention Group:

A patient introduction form and a state anxiety scale will be applied as a pre-test before transplant surgery, and vital signs will be checked. Patients will be shown 10-minute Turkish comedy films prepared by researchers before transplant surgery. After the intervention, vital signs will be checked as a post-test and a state anxiety scale will be applied. A quiet and calm environment will be provided in the patient room while patients are shown the comedy films.

Control Group:

A patient introduction form and a state anxiety scale will be applied as a pre-test before transplant surgery, and vital signs will be checked. No intervention will be made to the control group patients outside of the clinical protocol. After a certain waiting period (average of 30 minutes), the patients' vital signs will be checked and the state anxiety scale will be applied again.

Eligibility criteria: Inclusion Criteria:

* Being over 18 years of age,
* Being a liver transplant recipient,
* Data obtained before transplantation,
* Not having any visual or auditory problems.

Exclusion Criteria:

* Being under 18 years of age,
* Having any visual/auditory problems,
* Not accepting to participate in the study/wanting to leave,
* Not providing hemodynamic instability (sudden change in vital signs, etc.)

Primary outcomes:
measure: anxiety level
timeFrame: It will take approximately 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Bitlis
country: Turkey
facility: Bitlis Eren University
Study officials:
affiliation: Study Principal Investigator Bitlis Eren University
name: Şerafettin Okutan, Dr.
role: PRINCIPAL_INVESTIGATOR
References: