NCT07778355

Brief Summary

This study aims to evaluate the effect of operating room orientation video education delivered at different time points on postoperative pain and state anxiety in patients undergoing surgery for benign prostatic hyperplasia. Patients undergoing transurethral resection of the prostate or holmium laser enucleation of the prostate will be randomly assigned to one of three groups: video education one day before surgery in the surgical ward, video education approximately 30 minutes before surgery in the operating room waiting unit, or routine preoperative information. Pain and state anxiety will be assessed at predefined preoperative and postoperative time points.

Trial Health

63
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Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress18%
Sep 2026Mar 2027

First Submitted

Initial submission to the registry

August 18, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

August 21, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

August 18, 2026

Last Update Submit

August 18, 2026

Conditions

Keywords

Benign prostatic hyperplasiaTUR-PHoLEPoperating room orientationvideo educationpostoperative painanxietypatient education

Outcome Measures

Primary Outcomes (2)

  • Postoperative state anxiety

    State anxiety will be assessed using the State-Trait Anxiety Inventory-State Anxiety Scale (STAI-S), using the Turkish adaptation by Necla Öner and Ayhan Le Compte. State anxiety will be assessed one day before surgery in the surgical ward, before video education in the operating room waiting unit, and 6 hours after surgery in the surgical ward. The primary postoperative assessment will be the STAI-S score at 6 hours after surgery.

    From baseline to 6 hours after surgery

  • Postoperative pain intensity

    Pain intensity will be assessed using the Visual Analog Scale (VAS). Pain will be assessed one day before surgery in the surgical ward, before video education in the operating room waiting unit, and 6 hours after surgery in the surgical ward. The primary postoperative assessment will be the VAS score at 6 hours after surgery.

    From baseline to 6 hours after surgery

Study Arms (3)

Ward Video Education Group

EXPERIMENTAL

Participants will receive a 5-minute operating room orientation video approximately one day before surgery in the surgical ward.

Behavioral: Operating Room Orientation Video Education

Operating Room Waiting Unit Video Education Group

EXPERIMENTAL

Participants will receive the same 5-minute operating room orientation video approximately 30 minutes before surgery in the operating room waiting unit.

Behavioral: Operating Room Orientation Video Education

Routine Information Control Group

ACTIVE COMPARATOR

Participants will receive routine preoperative information according to standard clinical practice without the study-specific operating room orientation video.

Behavioral: Routine Preoperative Information

Interventions

A 5-minute video-based educational intervention designed to familiarize patients with the operating room environment and the perioperative process. The video includes information about the operating room environment, operating table, patient positioning, information related to the surgical process, the post-anesthesia care unit, and patient transfer.

Operating Room Waiting Unit Video Education GroupWard Video Education Group

Participants will receive routine preoperative information according to standard clinical practice without the study-specific operating room orientation video.

Routine Information Control Group

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being conscious and able to communicate. Being able to read and understand Turkish. Voluntarily agreeing to participate in the study and providing informed consent.
  • Having no visual or hearing impairment that would interfere with viewing the educational video or completing the study assessments.
  • Undergoing prostate surgery for the first time. Being 18 years of age or older.

You may not qualify if:

  • Having a diagnosed psychiatric disorder. Having a chronic pain syndrome. Being scheduled for emergency surgery. Having previously received similar operating room orientation education.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayıs University Health Practice and Research Center

Samsun, Atakum, 55500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic HyperplasiaPain, PostoperativeAnxiety Disorders

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsMental Disorders

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
no masking
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomly allocated to one of three parallel groups in a 1:1:1 allocation ratio using block randomization with a block size of three.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student

Study Record Dates

First Submitted

August 18, 2026

First Posted

August 21, 2026

Study Start

September 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

August 21, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be publicly shared to protect participant confidentiality and privacy. Aggregated study results will be reported in the master's thesis and subsequent scientific publications.

Locations