Care Acceptor, HealthNCT06805058
Effect of Comedy Therapy on Pain and Anxiety Levels After Ureterorenoscopy
A study testing comedy therapy in people with Care Acceptor, Health and Pain, Postoperative, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
Trial summary
The aim is to determine the effect of comedy therapy on pain and anxiety levels in patients after Uretero-Renoscopy (URS) surgery. The hypotheses of this study; H1-0: Comedy therapy has no effect on pain levels in patients after Uretero-Renoscopy surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Care Acceptor, Health, Pain, Postoperative, Anxiety Postoperative
- What is being tested?
- comedy therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 May 2025to 30 Nov 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 old,
- Not having any visual or auditory problems,
- Not having any communication problems,
- Not having any psychiatric problems.
Who cannot join
- Not accepting to participate in the study or wanting to leave,
- Having had complications during the perioperative process.
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
The aim is to determine the effect of comedy therapy on pain and anxiety levels in patients after Uretero-Renoscopy (URS) surgery.
The hypotheses of this study; H1-0: Comedy therapy has no effect on pain levels in patients after Uretero-Renoscopy surgery.
H1-1: Comedy therapy has an effect on pain levels in patients after Uretero-Renoscopy surgery.
H2-0: Comedy therapy has no effect on anxiety levels in patients after Uretero-Renoscopy surgery.
H2-1: Comedy therapy has an effect on anxiety levels in patients after Uretero-Renoscopy surgery.
Read the detailed description
Intervention Group
After URS surgery, patients whose condition is stable after coming to the clinic will be given a patient introduction form, numerical rating scale, state-trait anxiety scales as a pre-test. Patients will be shown 10-minute Turkish comedy films prepared by the researchers. After the intervention, numerical rating scale, state-trait anxiety scales will be given as a post-test.
Control Group
After URS surgery, patients whose condition is stable after coming to the clinic will be given a patient introduction form, numerical rating scale, state-trait anxiety scales as a pre-test. No intervention will be made to control group patients. After a certain waiting period, numerical rating scale, state-trait anxiety scales will be given as a post-test.
- Being tested
- comedy therapy
- Keywords
- comedy therapy, pain, anxiety, surgery
- Medical subject headings
- Patient Acceptance of Health Care, Pain, Postoperative, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comedy therapyOther
Patients will be shown 10-minute Turkish comedy films prepared by the researchers
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: Comedy therapy | Experimental | After URS surgery, patients whose condition is stable after coming to the clinic will be given a patient introduction form, numerical rating scale, state-trait anxiety scales as a pre-test. Patients will be shown 10-minute Turkish comedy films prepared by the researchers. After the intervention, numerical rating scale, state-trait anxiety scales will be given as a post-test. Receives: Other: comedy therapy |
| Control Group | No intervention | After URS surgery, patients whose condition is stable after coming to the clinic will be given a patient introduction form, numerical rating scale, state-trait anxiety scales as a pre-test. No intervention will be made to control group patients. After a certain waiting period, numerical rating scale, state-trait anxiety scales will be given as a post-test. |
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
anxiety level
State and Trait Anxiety Scale:
The adaptation and arrangement of the scales to Turkish was made by Necla Öner and Le Compte. Both scales consist of 20 items and are graded on a 4-point Likert scale. Scoring is done between 1-4.
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 posted3 Feb 2025
- Study start16 May 2025
- Primary completion30 Oct 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Care Acceptor, HealthStudies 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
- 110 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
- NCT06805058
- Sponsor's protocol ID
- okutan4
- Status last verified
- Feb 2026
- First submitted
- 28 Jan 2025
- Last updated
- 18 Feb 2026
- 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 18 Feb 2026. 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
- NCT06805058
- Acronym / sponsor ID
- okutan4
- Keywords
- comedy therapy, pain, anxiety, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Study start
- 16 May 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 3 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.
The aim is to determine the effect of comedy therapy on pain and anxiety levels in patients after Uretero-Renoscopy (URS) surgery.
The hypotheses of this study; H1-0: Comedy therapy has no effect on pain levels in patients after Uretero-Renoscopy surgery.
H1-1: Comedy therapy has an effect on pain levels in patients after Uretero-Renoscopy surgery.
H2-0: Comedy therapy has no effect on anxiety levels in patients after Uretero-Renoscopy surgery.
H2-1: Comedy therapy has an effect on anxiety levels in patients after Uretero-Renoscopy surgery.
Detailed description
Intervention Group
After URS surgery, patients whose condition is stable after coming to the clinic will be given a patient introduction form, numerical rating scale, state-trait anxiety scales as a pre-test. Patients will be shown 10-minute Turkish comedy films prepared by the researchers. After the intervention, numerical rating scale, state-trait anxiety scales will be given as a post-test.
Control Group
After URS surgery, patients whose condition is stable after coming to the clinic will be given a patient introduction form, numerical rating scale, state-trait anxiety scales as a pre-test. No intervention will be made to control group patients. After a certain waiting period, numerical rating scale, state-trait anxiety scales will be given as a post-test.
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: Comedy therapy | Experimental | Other: comedy therapyAfter URS surgery, patients whose condition is stable after coming to the clinic will be given a patient introduction form, numerical rating scale, state-trait anxiety scales as a pre-test. Patients will be shown 10-minute Turkish comedy films prepared by the researchers. After the intervention, numerical rating scale, state-trait anxiety scales will be given as a post-test. |
| Control Group | No intervention | –After URS surgery, patients whose condition is stable after coming to the clinic will be given a patient introduction form, numerical rating scale, state-trait anxiety scales as a pre-test. No intervention will be made to control group patients. After a certain waiting period, numerical rating scale, state-trait anxiety scales will be given as a post-test. |
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 old,
- Not having any visual or auditory problems,
- Not having any communication problems,
- Not having any psychiatric problems.
Key exclusion criteria (2 listed)
- Not accepting to participate in the study or wanting to leave,
- Having had complications during the perioperative process.
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 therapyPatients will be shown 10-minute Turkish comedy films prepared by the researchers | Other | Intervention Group: Comedy therapy |
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".
anxiety level
Time frame: It will take approximately 30 minutes
State and Trait Anxiety Scale: The adaptation and arrangement of the scales to Turkish was made by Necla Öner and Le Compte. Both scales consist of 20 items and are graded on a 4-point Likert scale. Scoring is done between 1-4.
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 18 Feb 2026.
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 Care Acceptor, Health 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 2 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 18 Feb 2026. 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 18 Feb 2026.