The Effect of Virtual Reality Glasses Application on Pain and Anxiety Levels in Colorectal Surgery Patients

NCT ID: NCT07065994

Last Updated: 2025-12-19

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

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2025-12-31

Brief Summary

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This study aims to determine the effect of virtual reality glasses on pain and anxiety levels in colorectal surgery patients. This study is a single-center, parallel-group, open-label, randomized controlled clinical trial. This study will be conducted with 60 patients who underwent colorectal surgery between August 2025 and December 2025. Participants will be randomized into two groups as the intervention group (n=30) and the control group (n=30).

All patients in the experimental and control groups will be asked to fill out the "Informed Consent Form" the day before the surgery, and the patients who agree to participate in the study will be asked to fill out the "Patient Introduction Form" and the "State Anxiety Scale" by the researchers.

The "Simulator Illness Questionnaire" used in the Virtual Reality disease field will be applied to the experimental group to determine their physiological conditions before the application. Then, a relaxing music-backgrounded video containing images of nature will be watched with virtual reality glasses for 10-15 minutes the day before the surgery. Then, the "Simulator Illness Questionnaire" and the "State Anxiety Scale" will be filled out again.

The "Simulator Illness Questionnaire" will be applied to the patients 2 hours after their transfer from the postoperative care unit to the clinic, which is the most appropriate time after the surgery, when their vital signs have stabilized and clinical compliance has been achieved, and their physiological conditions before the application will be determined. Then, the patients in the experimental group will be asked to watch a relaxing music-backgrounded video containing images of nature for 10-15 minutes with virtual reality glasses. The researcher will perform the video with virtual reality glasses in the patient rooms and beds. Afterwards, the "Simulator Disease Survey" will be repeated. There will be no compelling effect that will negatively affect the health of the patients during the application, and the application will be terminated when the patients feel uncomfortable. A safe environment will be created so that there are no objects around the patients that they can bump into or trip over. A 5-10 minute trial period will be performed at the beginning with the observer and the virtual reality glasses will be applied. The patient will be able to end the study at any time. If the patients use glasses/lenses, compliance will be checked.

No intervention will be applied to the control group patients and the routine practices of the clinic will continue.

All patients in the experimental and control groups will be assessed for pain with the Visual Analog Scale (VAS) at the 2nd and 4th hours and the "State Anxiety Scale" will be applied.

Detailed Description

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Conditions

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Colorectal Surgery Virtual Reality Nursing Care Pain Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental

All patients in the experimental group will be asked to fill out the "Informed Consent Form" the day before the surgery, and the patients who agree to participate in the study will be asked to fill out the "Patient Introduction Form" and the "State Anxiety Scale" by the researchers.

The "Simulator Illness Questionnaire" used in the Virtual Reality disease field will be applied to the experimental group to determine their physiological status before the application. Then, a relaxing music-backgrounded video containing nature images will be watched with virtual reality glasses for 10-15 minutes the day before the surgery. Then, the "Simulator Illness Questionnaire" and the "State Anxiety Scale" will be filled out again.

The "Simulator Illness Questionnaire" will be applied to the patients at the most appropriate time after the surgery, when their vital signs have stabilized and clinical compliance has been achieved, and 2 hours after their transfer from the postoperative care unit to th

Group Type EXPERIMENTAL

Virtual Reality Glasses Application

Intervention Type DEVICE

The day before the surgery, you will be shown a video of nature images with relaxing music for 10-15 minutes using virtual reality glasses.

Control

All patients in the control group will be given permission with the "Informed Consent Form" the day before the surgery, and the patients who agree to participate in the study will be asked to fill out the "Patient Introduction Form" and the "State Anxiety Scale" by the researchers.

No intervention will be applied to the control group patients, and the routine practices of the clinic will continue.

All patients in the experimental and control groups will be assessed for pain with the Visual Analog Scale (VAS) at the 2nd and 4th hours, and the "State Anxiety Scale" will be applied.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Virtual Reality Glasses Application

The day before the surgery, you will be shown a video of nature images with relaxing music for 10-15 minutes using virtual reality glasses.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients who are 18 years of age or older, 65 years of age or younger,
* Who will undergo laparoscopic colorectal surgery,
* Who do not develop any complications during or after the surgical procedure,
* Who volunteer to participate in the study will be included in the study.

Exclusion Criteria

* Patients who have not undergone laparoscopic surgery,
* Those who are hemodynamically unstable,
* Those with neurological or psychological problems,
* Those who are transferred to the intensive care unit after surgery,
* Emergency and unplanned cases,
* Those with visual, auditory or systemic disorders,
* Those who have balance problems,
* Those diagnosed with hypertension or hypotension,
* Patients diagnosed with anxiety disorder or epilepsy will be excluded from the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ankara Yildirim Beyazıt University

OTHER

Sponsor Role lead

Responsible Party

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Tuba Yılmazer

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara Yıldırım Beyazıt University

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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colorectalsurgery

Identifier Type: -

Identifier Source: org_study_id