- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06805058
Effect of Comedy Therapy on Pain and Anxiety Levels After Ureterorenoscopy
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.
Study Overview
Status
Intervention / Treatment
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 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 old,
- Not having any visual or auditory problems,
- Not having any communication problems,
- Not having any psychiatric problems.
Exclusion Criteria:
- Not accepting to participate in the study or wanting to leave,
- Having had complications during the perioperative process.
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 |
|---|---|
|
No Intervention: 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.
|
|
|
Experimental: Intervention Group: Comedy therapy
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.
|
Patients will be shown 10-minute Turkish comedy films prepared by the researchers
|
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
|
|
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. |
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 (Actual)
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
- okutan4
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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