- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06816628
Effects of Comedy Therapy on Pain and Comfort Levels in Liver Transplant Recipients
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
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bitlis, Turkey (Türkiye), 13100
- Bitlis Eren University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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: 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.
|
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
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
Sponsor
Investigators
- Principal Investigator: Şerafettin OKUTAN, Dr., Study Principal Investigator Bitlis Eren University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- okutan5
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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