Colorectal SurgeryNCT07065994
The Effect of Virtual Reality Glasses Application on Pain and Anxiety Levels in Colorectal Surgery Patients
A study testing Virtual Reality Glasses Application in people with Colorectal Surgery and Virtual Reality, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Surgery, Virtual Reality, Nursing Care
- What is being tested?
- Virtual Reality Glasses Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- Those who have balance problems,
- Those diagnosed with hypertension or hypotension,
- Patients diagnosed with anxiety disorder or epilepsy will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Colorectal Surgery, Virtual Reality, Nursing Care, Pain, Anxiety
- Being tested
- Virtual Reality Glasses Application
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Glasses ApplicationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | 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 Receives: Device: Virtual Reality Glasses Application |
| Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
VAS is a scale consisting of 10 cm lines (0-10 cm) used to assess pain. 0 means "no pain" and 10 means "unbearable pain". In this method, the patient is asked to mark the number between these two extreme points and the degree of pain (F. E. Aslan, 2002).
Measured: preoperative, postoperative 2 hours, postoperative 4 hours
Spielberger State and Trait Anxiety Inventory (STAI)
STAI, which is widely used and still valid, was developed by Spielberger, Gorsuch and Lushene in 1970, and its Turkish language and content validity was made by Öner and Le Compte in 1983. It consists of 2 subscales covering 20 statements measuring state and trait anxiety. The State Anxiety Subscale (STAI-S) expresses how an individual feels at a certain moment and under certain conditions; and the Trait Anxiety Subscale (STAI-T) expresses how they generally feel. The inventory is answered through 4-dimensional definitions. The feelings and behaviors expressed in the State Anxiety Subscale items are specified by selecting one of the options "(1) None, (2) Some, (3) A lot and (4) Completely" according to the severity of such experiences. The feelings and behaviors expressed in the Trait Anxiety Subscale items are specified according to their frequency levels; It is expressed as "(1) Almost Never, (2) Sometimes, (3) A Lot of the Time, and (4) Almost Always". High scores from each subsca
Measured: preoperative, postoperative 2 hours, postoperative 4 hours
Simulator Sickness Questionnaire (SSQ)
Simulation Sickness Questionnaire (SSQ) is widely used to measure Virtual Reality sickness (Sevinc and Berkman, 2020, Igoshina et al. 2022). Simulator sickness questionnaire consists of 16 questions. These questions are located under 4 components: nausea (N), oculomotor (O), disorientation (D) and weighted total (T). The majority of studies conducted using SSQ reported only the Total Score score (Sevinc, and Berkman, 2020).
Measured: preoperative, postoperative 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Aug 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba Yılmazer, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065994
- Sponsor's protocol ID
- colorectalsurgery
- Status last verified
- Dec 2025
- First submitted
- 26 Jun 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses Application on Pain and Anxiety Levels in Colorectal Surgery Patients
- ClinicalTrials.gov ID
- NCT07065994
- Acronym / sponsor ID
- colorectalsurgery
- Conditions
- Colorectal Surgery, Virtual Reality, Nursing Care, Pain, Anxiety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Virtual Reality Glasses ApplicationAll 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 |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Glasses ApplicationThe day before the surgery, you will be shown a video of nature images with relaxing music for 10-15 minutes using virtual reality glasses. | Device | Experimental |
Primary outcome
Visual Analog Scale (VAS)
Time frame: preoperative, postoperative 2 hours, postoperative 4 hours
VAS is a scale consisting of 10 cm lines (0-10 cm) used to assess pain. 0 means "no pain" and 10 means "unbearable pain". In this method, the patient is asked to mark the number between these two extreme points and the degree of pain (F. E. Aslan, 2002).
Spielberger State and Trait Anxiety Inventory (STAI)
Time frame: preoperative, postoperative 2 hours, postoperative 4 hours
STAI, which is widely used and still valid, was developed by Spielberger, Gorsuch and Lushene in 1970, and its Turkish language and content validity was made by Öner and Le Compte in 1983. It consists of 2 subscales covering 20 statements measuring state and trait anxiety. The State Anxiety Subscale (STAI-S) expresses how an individual feels at a certain moment and under certain conditions; and the Trait Anxiety Subscale (STAI-T) expresses how they generally feel. The inventory is answered through 4-dimensional definitions. The feelings and behaviors expressed in the State Anxiety Subscale items are specified by selecting one of the options "(1) None, (2) Some, (3) A lot and (4) Completely" according to the severity of such experiences. The feelings and behaviors expressed in the Trait Anxiety Subscale items are specified according to their frequency levels; It is expressed as "(1) Almost Never, (2) Sometimes, (3) A Lot of the Time, and (4) Almost Always". High scores from each subsca
Simulator Sickness Questionnaire (SSQ)
Time frame: preoperative, postoperative 2 hours
Simulation Sickness Questionnaire (SSQ) is widely used to measure Virtual Reality sickness (Sevinc and Berkman, 2020, Igoshina et al. 2022). Simulator sickness questionnaire consists of 16 questions. These questions are located under 4 components: nausea (N), oculomotor (O), disorientation (D) and weighted total (T). The majority of studies conducted using SSQ reported only the Total Score score (Sevinc, and Berkman, 2020).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Glasses Application in people with Colorectal Surgery and Virtual Reality, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: preoperative, postoperative 2 hours, postoperative 4 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.