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

NCT06919588 | Completed DMC

• 1 other identifier: okutan7
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplant; Complications; Stress; Care Acceptor, Health

Keywords

stress; vital signs; pre-operative; liver; transplant; comedy films

Outcome Measures

Primary Outcomes (1)

• anxiety level

  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.

Study Arms (2)

comedy therapy

EXPERIMENTAL

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.

Behavioral: comedy therapy

standard of care

NO INTERVENTION

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.

Interventions

comedy therapy BEHAVIORAL

Before the transplant surgery, the patients were shown 10-minute Turkish comedy films prepared by the researchers.

comedy therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Bitlis Eren University: lead

Study Sites (1)

Bitlis Eren University

Bitlis, 13100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Şerafettin Okutan, Dr.

  Study Principal Investigator Bitlis Eren University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University

Model Details: It will be conducted as a randomized controlled experimental study in a pretestpost- test control group experimental model.

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 9, 2025
• Study Start: April 1, 2024
• Primary Completion: April 15, 2024
• Study Completion: August 30, 2024
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

TU (1)