NCT06830330

Brief Summary

The goal of this clinical trial is to learn if virtual reality application effects on anxiety and fear in patients who will undergo abdominal surgery. It will also learn about the practical of virtual reality application in preoperative theatre. The main questions it aims to answer are:

  • Does virtual reality reduce patient anxiety levels before surgery?
  • Is virtual reality useful for patients to watch videos in the preoperative area? Researchers will compare virtual reality videos to routine nursing care to see if virtual reality works to treat preoperative anxiety and surgical fear. Participants will:
  • watch videos of nature scenes with VR glasses in the waiting area before surgery.
  • answer the surgical fear quastionairre items for preoperative fear test

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 20, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

February 11, 2025

Last Update Submit

February 22, 2025

Conditions

Preoperative PatientsPatients Undergoing Abdominal Surgery

Keywords

preoperative anxietysurgical fearvirtual realityAnxiety State

Outcome Measures

Primary Outcomes (1)

  • State Anxiety Level Change

    The effect of virtual reality intervention on preoperative anxiety level is safely evaluated.

    The state anxiety scale were applied to the patients 15 minutes after they watched the video with virtual reality glasses.

Secondary Outcomes (1)

  • Change in fear level related to surgery

    The surgical fear scale were applied to the patients 15 minutes after they watched the video with virtual reality glasses.

Study Arms (2)

Virtual Reality Group

EXPERIMENTAL

Virtual Reality Group

Behavioral: Virtual reality

Control Group

NO INTERVENTION

Control group

Interventions

Virtual realityBEHAVIORAL

Patients in the experimental group were shown videos of natural landscapes with VR glasses in their beds. This application was used to distract patients who were experiencing negative emotions just before surgery. The video session begins with the introduction of the virtual reality glasses. A motionless virtual area is determined at the point where the patient's stretcher is located. The glasses are placed on the patient's head and both hands of the patient are trained to use the remote control. Video content is selected and started according to the patient's preference. Video sessions last approximately 10 minutes.

Virtual Reality Group

Eligibility Criteria

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

You may qualify if:

  • Patients scheduled for abdominal surgery under general anesthesia using the laparoscopic method
  • Patients who can communicate
  • Patients who agree to participate in the study
  • Patients over the age of 18

You may not qualify if:

  • Patients who use glasses
  • Patients with an ASA score above 3
  • Patients with vertigo and motion sickness
  • Patients with known psychiatric or behavioral diagnoses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balcali Hospital Health Application and Research Center

Adana, Sarıçam, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Sevban A Proffessor doctor

    Çukurova University, Faculty of Health Science

    STUDY DIRECTOR

Central Study Contacts

Nursevim A research assistant

CONTACT

+905458504330nursevimaydingulu@gmail.com

Muaz G Lecturer

CONTACT

+905316680452muaz.gulsen@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were blinded using a single-blind method.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study was conducted as a randomized, controlled, interventional study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assisstant

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 17, 2025

Study Start

August 20, 2024

Primary Completion

February 5, 2025

Study Completion

March 1, 2025

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Ethics committee approval was obtained for the study to be conducted. For this reason, participant data cannot be shared.

Available IPD Datasets

ethics committee approval Access

Locations

TU(1)