Liver Transplant; ComplicationsNCT06816628
Effects of Comedy Therapy on Pain and Comfort Levels in Liver Transplant Recipients
A study testing comedy therapy in people with Liver Transplant; Complications and Pain, Postoperative, 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 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant; Complications, Pain, Postoperative, Care Acceptor, Health
- What is being tested?
- comedy therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2025to 7 Oct 2025
- 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 after 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 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.
Read the 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.
- Being tested
- comedy therapy
- Keywords
- pain, comfort, transplant, liver, post-operatif
- Medical subject headings
- Pain, Postoperative, Patient Acceptance of Health Care, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comedy therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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. Receives: Other: comedy therapy |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
pain level
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".
Measured: It will take approximately 5 minutes
comfort level
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.
Measured: It will take approximately 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start15 Feb 2025
- Primary completion25 Sep 2025
- Study completion7 Oct 2025
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 pre-testpost- 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
- NCT06816628
- Sponsor's protocol ID
- okutan5
- Status last verified
- Nov 2025
- First submitted
- 31 Jan 2025
- Last updated
- 4 Dec 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 4 Dec 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
- NCT06816628
- Acronym / sponsor ID
- okutan5
- Keywords
- pain, comfort, transplant, liver, post-operatif
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 7 Oct 2025 (actual)
- First posted
- 10 Feb 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 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.
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 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 pre-testpost- test control group experimental model.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: comedy therapyA 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 | No intervention | –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. |
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 after 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 therapyAfter patients came to the clinic after transplantation surgery and their condition was stable, 10-minute Turkish comedy films prepared by the researchers were shown. | Other | Intervention Group |
Primary outcome
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".
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.
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 4 Dec 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 Pain, Postoperative, 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 4 Dec 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?
pain level (time frame: It will take approximately 5 minutes). The study lists 2 primary outcomes in all. 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 4 Dec 2025.