NCT06805058

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

May 16, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

January 28, 2025

Last Update Submit

February 15, 2026

Conditions

Keywords

comedy therapypainanxietysurgery

Outcome Measures

Primary Outcomes (2)

  • 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".

    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.

    It will take approximately 30 minutes

Study Arms (2)

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.

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.

Interventions

Patients will be shown 10-minute Turkish comedy films prepared by the researchers

Intervention Group: Comedy therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being over 18 years old,
  • Not having any visual or auditory problems,
  • Not having any communication problems,
  • Not having any psychiatric problems.

You may not qualify if:

  • Not accepting to participate in the study or wanting to leave,
  • Having had complications during the perioperative process.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bitlis Eren University

Bitlis, 13100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patient Acceptance of Health CarePain, PostoperativePainAnxiety Disorders

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsMental Disorders

Study Officials

  • Şerafettin OKUTAN, Dr.

    Study Principal Investigator Bitlis Eren University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: It will be conducted as a randomized controlled experimental study in a pre-testpost- test control group experimental model.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University

Study Record Dates

First Submitted

January 28, 2025

First Posted

February 3, 2025

Study Start

May 16, 2025

Primary Completion

October 30, 2025

Study Completion

November 30, 2025

Last Updated

February 18, 2026

Record last verified: 2026-02

Locations