The Effect of Virtual Reality Education on Preoperative Anxiety, Postoperative Pain, and Sleep in Patients Undergoing Colon Surgery

NCT ID: NCT07297095

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-20

Study Completion Date

2026-11-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The effect of patient education given to patients undergoing colon surgery using virtual reality in the preoperative period on preoperative anxiety, postoperative pain and sleep is the subject of this study.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will be conducted to investigate the effects of patient education provided through virtual reality in the preoperative period to patients undergoing colon surgery on preoperative anxiety, postoperative pain, and sleep. The population of this randomized controlled experimental study will consist of patients who will undergo colon surgery in the General Surgery Department of a university hospital after obtaining ethics committee and institutional approval. The population of the study will consist of patients who will undergo colon surgery in the General Surgery Department of a university hospital after obtaining ethics committee and institutional approval. The required sample size and power calculations for this study were made using the G\*Power 3.1.9.2 program. A type 1 error of 0.05, a confidence interval of 90%, and an effect size of 0.72 (Uğraş et al., 2023) were calculated. In the calculation, 41 patients were calculated for each of the intervention and control groups, and the number was increased by 10% to account for losses, with 45 patients each, for a total of 90 patients. "Patient Information Form", "Surgical Anxiety Scale", "Richard Campbell Sleep Scale", "Visual Analog Scale (VAS)" will be used as data collection tools. After completing the "Patient Information Form" on patients who provided informed consent, the "Surgical Anxiety Scale" will be administered to patients in the intervention and control groups upon admission. The intervention group will receive training using a 3D animated patient education video prepared with virtual reality glasses. The control group will receive routine verbal education. Following the training, the "Surgical Anxiety Scale" will be administered a second time to patients. Postoperative pain and sleep assessments will then be conducted in both the control and intervention groups. Pain intensity will be measured with the Visual Analog Scale (VAS) at the 8th, 16th, and 24th postoperative hours for both groups. Postoperative sleep quality will be assessed with the "Richard Campbell Sleep Scale" at the 24th postoperative hour for both groups. IBM SPSS Statistics 22.0 will be used for data analysis and evaluation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preoperative Anxiety Virtual Reality Postoperative Pain Management Postoperative Sleep

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

virtual reality preoperative anxiety postoperative sleep postoperative pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

experimental

Participants in the intervention group will receive training in the patient room of the General Surgery Clinic using a training video prepared with virtual reality glasses. The training video will include an introduction to the devices used in the ward during the preoperative period, from blood pressure cuffs to monitors. On the first postoperative day, the Richards Campbell Sleep Scale will be administered to the intervention and control groups. At 8, 16, and 24 hours, the intervention and control groups will be assessed for pain intensity using the Visual Analog Scale (VAS).

Group Type EXPERIMENTAL

preoperative patient education via virtual reality device

Intervention Type OTHER

In the General Surgery Clinic, intervention group participants will receive training in the patient room using a virtual reality headset. The training video will include an introduction to the devices used in the ward during the preoperative period, from blood pressure cuffs to monitors. A training video will be prepared explaining that the patient will be monitored upon returning to the room after the surgery, will be monitored frequently, will be questioned about pain and sleep, and that their family and nurse will be available for any needs they may have.

control group

The control group will receive routine verbal training as applied in the classical hospital procedure. The control group will receive routine verbal training as applied in the classical hospital procedure.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

preoperative patient education via virtual reality device

In the General Surgery Clinic, intervention group participants will receive training in the patient room using a virtual reality headset. The training video will include an introduction to the devices used in the ward during the preoperative period, from blood pressure cuffs to monitors. A training video will be prepared explaining that the patient will be monitored upon returning to the room after the surgery, will be monitored frequently, will be questioned about pain and sleep, and that their family and nurse will be available for any needs they may have.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients who agree to participate in the study will be included:

They are undergoing surgery for the first time,

They have not received preoperative training,

They will undergo colon surgery,

They are over 18 years of age,

They are eligible for the Virtual Reality Discomfort Questionnaire,

They do not have claustrophobia.

Exclusion Criteria

* Patients who have had multiple surgeries, Patients with head and neck, vision, or hearing problems that prevent them from wearing virtual reality glasses, Patients who had a stoma created during surgery, Patients who wish to withdraw from the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ankara Yildirim Beyazıt University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sema Koçaşlı, Assist. Prof. Dr.

Role: STUDY_DIRECTOR

Ankara Yildirim Beyazıt University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Nursing

Ankara, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

08/832

Identifier Type: -

Identifier Source: org_study_id