NCT06936540

Brief Summary

The purpose of the study is to determine the effect of training on surgical environments provided with virtual tour before orthopedic surgical ıntervention on patients' anxiety and satisfaction level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable anxiety

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

April 12, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

April 12, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 20, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2025

Completed
Last Updated

November 18, 2025

Status Verified

April 1, 2025

Enrollment Period

6 months

First QC Date

April 12, 2025

Last Update Submit

November 16, 2025

Conditions

Keywords

AnxietySatisfactionVirtual RealityOrthopedic Surgical Procedures

Outcome Measures

Primary Outcomes (1)

  • State-Trait Anxiety Inventory (STAI): Pre-test and post-test differences of anxiety levels

    The State-Trait Anxiety Inventory (STAI) is accepted as the the gold standard to determine the level of anxiety. The validity and reliability of the STAI in Turkey was conducted by Oner and Le Compte. The STAI can be administered to individuals over the age of 14 and there is no time limit for answering. It includes two separate scales of twenty items each (ie, the State Anxiety Scale (STAI-S) and the Trait Anxiety Scale (STAI-T). STAI-S and STAI-T scores are calculated separately. The total score obtained from the scales varies between 20 and 80, and a high score indicates a high level of anxiety.

    From immediately before preoperative training to immediately after preoperative training (on the day before surgery).

Secondary Outcomes (1)

  • Visual Analog Scale (VAS) for Satisfaction: Pre-test and post-test differences of satisfaction levels

    From immediately before preoperative training to immediately after preoperative training (on the day before surgery).

Study Arms (2)

Intervention group

OTHER

The intervention group will be trained by the researcher with a virtual tour material about surgical environments via a tablet computer.

Other: Virtual Tour

Control group

OTHER

The control group will not receive any intervention other than verbal training in the routine of the organization.

Other: No Interventions

Interventions

The intervention group will be trained by the researcher with a virtual tour material about surgical environments via a tablet computer.

Intervention group

The control group will not receive any intervention other than verbal training in the routine of the organization.

Control group

Eligibility Criteria

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

You may qualify if:

  • Between the ages of 18-65
  • Being literate
  • No comprehension and perception problems
  • No hearing and vision problems
  • Not being under psychiatric treatment
  • No surgical experience
  • To undergo elective orthopedic surgery in the operating room
  • Acceptance to participate in the research

You may not qualify if:

  • To undergo emergency orthopedic surgery
  • Wishing to leave at any stage of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa Institute of Graduate Studies

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPersonal Satisfaction

Condition Hierarchy (Ancestors)

Mental DisordersBehavior

Study Officials

  • Seda Baydemir, PhD-candidate

    Istanbul University-Cerrahpasa Institute of Graduate Studies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The study was planned as an open-label, randomized, controlled, parallel group interventional study. Participants will be randomly assigned to either the intervention group or the control group. The intervention group will be trained by the researcher with a virtual tour material about surgical environments via a tablet computer. The control group will not receive any intervention other than verbal training in the routine of the organization.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 12, 2025

First Posted

April 20, 2025

Study Start

April 12, 2025

Primary Completion

October 12, 2025

Study Completion

October 12, 2025

Last Updated

November 18, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations