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Clinical Trials/NCT06805058
NCT06805058CompletedNot Applicable

Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University

Bitlis Eren University1 site in 1 country110 target enrollmentStarted: May 16, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
110
Locations
1
Primary Endpoint
pain level

Study Overview

Brief 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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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.

Intervention: comedy therapy (Other)

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Bitlis Eren University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Serafettin Okutan

Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University

Bitlis Eren University

Study Sites (1)

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