The Effect of Preoperative Training With Virtual Reality on Anxiety, Readiness for Surgery and Recovery Process of Patients in Colorectal Cancer Surgery

December 18, 2025 updated by: Ozkan Karadede, Istanbul University - Cerrahpasa

The aim of the study is to determine the effect of The Effect of Preoperative Training with Virtual Reality on Anxiety, Readiness for Surgery and Recovery Process of Patients in Colorectal Cancer Surgery.

Research Hypotheses

In patients undergoing colorectal surgery:

H1 The comfort level of patients who received preoperative training using virtual reality is higher than that of patients who received training using written brochures and the control group.

H2. The anxiety level of patients who received preoperative education using the virtual reality method is lower than that of patients who received education via written brochures and the control group.

H3 The satisfaction level of patients who received preoperative education using the virtual reality method is lower than that of patients who received education via written brochures and the control group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye), 34090
        • Recruiting
        • İstanbul University-Cerrahpaşa
        • Contact:
          • Özkan Karadede, Msc
          • Phone Number: +905067705766

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Agreement to participate in the study, Ability to read and write in Turkish, Being conscious and communicative.

Exclusion Criteria:

Those with any psychiatric illness, Those diagnosed with an anxiety disorder and taking medication for anxiety, Those with active nausea, vomiting, or headache, Those with vision or hearing problems, Those with a history of seizures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: control group
Experimental: virtual reality group
Patients undergoing colorectal surgery will be trained using virtual reality glasses.
Device: Patients undergoing colorectal surgery will be trained using virtual reality glasses.
Patients undergoing colorectal surgery will be trained using virtual reality glasses.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
(State Trait Anxiety Inventory I-II)
Time Frame: 24 hour

STAI I determines how an individual feels at a specific moment and under specific conditions. The State-Trait Anxiety Inventory (STAI II) determines how individuals generally feel in their current situation and conditions.

Inventory items are scored between 1 and 4. High scores on the inventory indicate that the person has high levels of state and trait anxiety. Scores between 0 and 19 on the inventory indicate no anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, and 60-80 points indicate severe anxiety.
24 hour
The Preparedness for Colorectal Cancer Surgery Questionnaire (PCSQ)
Time Frame: 24 hour
The scale determines whether the verbal and written information provided about the surgery prepares individuals for the surgery. The scale is a 4-point Likert scale ranging from positive to negative. The scale consists of a total of 24 items. The score that can be obtained from the scale ranges from 0 to 96. Item 24 on the scale is reverse-scored. The scale is evaluated by calculating the total score of the items. High scores indicate a high level of readiness.
24 hour
Recovery Quality-40 Survey (QoR-40)
Time Frame: 24 hour
The scale consists of a total of 40 items. It comprises five subscales: emotional state, physical comfort, patient support, physical independence, and pain. The scale is a 5-point Likert scale, and items are scored on a scale of 1 to 5. Subscale averages are obtained by summing the scores for each subscale, and the total survey score is obtained by summing all items. A higher score indicates that patients' physical and emotional well-being is at the expected level (good condition) post-surgery. A low score indicates that the patient's well-being post-surgery has been negatively affected.
24 hour

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cortisol Level
Time Frame: 24 hour
Cortisol, commonly known as the "stress hormone," is essential for life. When stress occurs, cortisol levels increase. Cortisol is secreted by the adrenal cortex in response to various stimuli. It enables the organism to adapt to its environment. Cortisol helps the organism defend against dangers by enhancing its homeostasis ability. Cortisol levels were measured using saliva samples taken at specified times.
24 hour
Number of Steps
Time Frame: 24 hour
A pedometer wristband was used to monitor the patient's daily physical activities and determine the number of steps taken.
24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 5, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 9, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-83045809-604.01-1017096

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified individual participant data (IPD) collected in this study will be shared with other researchers for scientific purposes. The data to be shared will include anonymized demographic characteristics, outcome measures, and variables used in the analyses, with no information that could directly or indirectly identify individual participants. Data will be made available after publication of the primary study results. Access to the data will be granted upon reasonable request, subject to submission of a written scientific proposal and confirmation of compliance with ethical standards. The data will be provided through a secure external data-sharing platform, and a link to the dataset will be made available in the ClinicalTrials.gov record when accessible.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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