NCT07297095

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Nov 2025

Geographic Reach
1 country

1 active site

Status
active not 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 Progress46%
Nov 2025Nov 2026

Study Start

First participant enrolled

November 20, 2025

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 22, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2026

Expected
Last Updated

December 22, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

December 9, 2025

Last Update Submit

December 9, 2025

Conditions

Keywords

virtual realitypreoperative anxietypostoperative sleeppostoperative pain

Outcome Measures

Primary Outcomes (1)

  • The Visual Analog Scale (VAS) Richard Campbell Sleep Quality Scale Surgical Anxiety Scale

    The Visual Analog Scale (VAS) will be used in the study to assess patients' pain. It is a simple, effective, repeatable, and minimally instrumental measurement tool. Richard Campbell Sleep Quality Scale Developed by Richards, this six-item scale measures the depth and quality of nighttime sleep, time to fall asleep, frequency of awakenings and duration of wakefulness, and ambient noise. Surgical Anxiety Scale The scale has three subscales: health-related anxiety, recovery-related anxiety, and procedure-related anxiety.

    6 month

Study Arms (2)

experimental

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).

Other: preoperative patient education via virtual reality device

control group

NO INTERVENTION

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.

Interventions

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.

experimental

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Sema Koçaşlı, Assist. Prof. Dr.

    Ankara Yildirim Beyazıt University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2025

First Posted

December 22, 2025

Study Start

November 20, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

November 20, 2026

Last Updated

December 22, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations