Effects of Comedy Therapy on Pain and Comfort Levels in Liver Transplant Recipients

November 27, 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 pain and comfort levels in liver transplant recipients during the postoperative period.

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

H1-1: Watching classical Turkish comedy films reduces postoperative pain in liver transplant recipients.

H2-0: Watching classical Turkish comedy films has no effect on postoperative comfort levels in liver transplant recipients.

H2-1: Watching classical Turkish comedy films increases postoperative comfort levels in liver transplant recipients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Intervention Group A patient introduction form, numerical rating scale and general comfort scale were applied as a pre-test after transplantation surgery. After patients came to the clinic after transplantation surgery and their condition was stable, 10-minute Turkish comedy films prepared by the researchers were shown. After the intervention, a numerical rating scale and general comfort scale were applied as a post-test. While patients watched the comedy films, a quiet and calm environment was provided in the patient room.

Control Group A patient introduction form, numerical rating scale and general comfort scale were applied as a pre-test after transplantation surgery. No intervention was made to the control group patients outside of the clinical protocol. After patients came to the clinic after liver transplantation and their condition was stable, the numerical rating scale and general comfort scale were applied again.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 after 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
A patient introduction form, numerical rating scale and general comfort scale were applied as a pre-test after transplantation surgery. After patients came to the clinic after transplantation surgery and their condition was stable, 10-minute Turkish comedy films prepared by the researchers were shown. After the intervention, a numerical rating scale and general comfort scale were applied as a post-test. While patients watched the comedy films, a quiet and calm environment was provided in the patient room.
Other: comedy therapy
After patients came to the clinic after transplantation surgery and their condition was stable, 10-minute Turkish comedy films prepared by the researchers were shown.
No Intervention: Control Group
A patient introduction form, numerical rating scale and general comfort scale were applied as a pre-test after transplantation surgery. No intervention was made to the control group patients outside of the clinical protocol. After patients came to the clinic after liver transplantation and their condition was stable, the numerical rating scale and general comfort scale were applied again.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
pain level
Time Frame: It will take approximately 5 minutes
Patients' pain level will be measured with a "numerical rating scale". In the form, 0 points are evaluated as "no pain", 1-3 points as "mild pain", 4-6 points as "moderate pain", 7 and above points as "severe pain".
It will take approximately 5 minutes
comfort level
Time Frame: It will take approximately 30 minutes

General Comfort Scale:

The general comfort scale was created by taking as a guide the taxonomic structure that includes three levels and four dimensions that constitute the theoretical components of comfort and is used to determine comfort requirements and to evaluate the situation of reaching the expected increase in comfort with nursing interventions that provide comfort. The scale is a four-point/six-point Likert type and contains a total of 48 items. The four-point Likert type was preferred in the study due to its ease of use. The lowest score that can be obtained from the scale is 48, the highest score is 192. High scores indicate a high level of comfort.
It will take approximately 30 minutes

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bitlis Eren University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 25, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 7, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • okutan5

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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