Effects of Comedy Therapy on Anxiety and Vital Signs in Transplant Recipients

September 17, 2025 updated by: Serafettin Okutan, Bitlis Eren University

Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: comedy therapy
Before transplant surgery, a patient introduction form and a state anxiety scale will be applied as a pre-test, 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. While patients are shown the comedy films, a quiet and calm environment will be provided in the patient room.
Before the transplant surgery, the patients were shown 10-minute Turkish comedy films prepared by the researchers.
No Intervention: standard of care
Before transplant surgery, a patient introduction form and a state anxiety scale will be applied as a pre-test, 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anxiety level
Time Frame: Between April and August.

The anxiety levels of patients will be measured using the "State and Trait Anxiety Scale".

State and Trait Anxiety Scale; consists of two scales. Each scale has 20 questions. Scoring is between 1-4. Each scale score varies between 20-80 points. A high scale score indicates high anxiety. A low scale score indicates low anxiety.

Between April and August.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Şerafettin OKUTAN, Dr., Study Principal Investigator Bitlis Eren University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

April 15, 2024

Study Completion (Actual)

August 30, 2024

Study Registration Dates

First Submitted

April 2, 2025

First Submitted That Met QC Criteria

April 8, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Estimated)

September 23, 2025

Last Update Submitted That Met QC Criteria

September 17, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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