- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06919588
Effects of Comedy Therapy on Anxiety and Vital Signs in 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 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
Status
Intervention / Treatment
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
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 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
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
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- okutan7
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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