Liver Transplant; ComplicationsNCT06919588
Effects of Comedy Therapy on Anxiety and Vital Signs in Transplant Recipients
A study testing comedy therapy in people with Liver Transplant; Complications and Stress, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant; Complications, Stress, Care Acceptor, Health
- What is being tested?
- comedy therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 30 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being over 18 years of age,
- Being a liver transplant recipient,
- Data obtained before transplantation,
- Not having any visual or auditory problems.
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- comedy therapy
- Keywords
- stress, vital signs, pre-operative, liver, transplant, comedy films
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comedy therapyBehavioural
Before the transplant surgery, the patients were shown 10-minute Turkish comedy films prepared by the researchers.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Between April and August.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Apr 2024
- Primary completion15 Apr 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- It will be conducted as a randomized controlled experimental study in a pretestpost- test control group experimental model.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitlis Eren University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serafettin Okutan, Bitlis Eren University
- Investigators
- Şerafettin Okutan, Dr., Principal investigator, Study Principal Investigator Bitlis Eren University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919588
- Sponsor's protocol ID
- okutan7
- Status last verified
- Sep 2025
- First submitted
- 2 Apr 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University
- ClinicalTrials.gov ID
- NCT06919588
- Acronym / sponsor ID
- okutan7
- Keywords
- stress, vital signs, pre-operative, liver, transplant, comedy films
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It will be conducted as a randomized controlled experimental study in a pretestpost- test control group experimental model.
| Arm | Type | Receives |
|---|---|---|
| comedy therapy | Experimental | Behavioral: comedy therapyBefore 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being over 18 years of age,
- Being a liver transplant recipient,
- Data obtained before transplantation,
- Not having any visual or auditory problems.
Key exclusion criteria (4 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comedy therapyBefore the transplant surgery, the patients were shown 10-minute Turkish comedy films prepared by the researchers. | Behavioural | comedy therapy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şerafettin Okutan, Dr. principal investigator
Study Principal Investigator Bitlis Eren University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comedy therapy in people with Liver Transplant; Complications and Stress, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety level (time frame: Between April and August.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.