ColonoscopyNCT06407531
Before Colonoscopy Effect of Virtual Reality Application on Anxiety and Vital Signs
A study testing VR-G in people with Colonoscopy, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to examine the effect of virtual reality application on the patient's anxiety and vital signs before colonoscopy. The hypotheses of the research are as follows: H1: Virtual reality application before colonoscopy has an effect on patients' anxiety and vital signs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- VR-G
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Nov 2023to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteering to participate in the research,
- Being literate,
- Be 18 years or older.
Who cannot join
- Performing colonoscopy at the same time as endoscopy,
- Using any analgesic or anxiolytic,
- Having a visual or hearing impairment,
- Performing an emergency colonoscopy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining the Effect of Virtual Reality Application on Patient's Anxiety and Vital Signs Before Colonoscopy: A Randomized Controlled Study
This study was planned to examine the effect of virtual reality application on the patient's anxiety and vital signs before colonoscopy. The hypotheses of the research are as follows:
H1: Virtual reality application before colonoscopy has an effect on patients' anxiety and vital signs.
H0: Virtual reality application before colonoscopy has no effect on patients' anxiety and vital signs.
Before colonoscopy, patients in the study group will be asked to watch videos using virtual reality glasses.
Read the detailed description
After obtaining the ethics committee and institutional permission for the research, the researcher was taken to the hospital for the colonoscopy procedure.
He/she will introduce himself/herself to the patients and explain the purpose of the research. Patients who volunteered to participate in the study Informed consent will be obtained. Data regarding the socio-demographic characteristics of the patients included in the patient introduction form The patient will be interviewed face to face, and data regarding the patients' clinical characteristics will be recorded from the patient file. colonoscopy Data will begin to be collected from the first patient to undergo the procedure. Anxiety and life assessment with VAS 30 minutes before the procedure The findings will be considered. According to the randomization, the patient in the virtual reality glasses group was first asked by the researcher.
It will be explained to the patient that he will wear the glasses for 30 minutes and watch a video before the procedure. By researcher 30 When the minute is up, the patient will be informed and asked to remove the glasses. No intervention was made to the patient in the control group.
It will not be done. Anxiety and vital signs were measured with VAS 5-10 minutes before the procedure began in all patient groups.
will be looked into. After each patient use, the virtual reality glasses will be cleaned and dried with alcohol-based cleaning material.
- Conditions
- Colonoscopy
- Being tested
- VR-G
- Keywords
- virtual reality glasses, surgical nursing, colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR-GOther
Patients watched videos with virtual glasses before undergoing colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| VR-G | Experimental | The patient will wear virtual glasses and watch a video 30 minutes before the procedure. Receives: Other: VR-G |
| Control | No intervention | No intervention will be performed on control group patients and the standard care protocol of the clinic will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety (Visual Analog Scale-Anxiety)
Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.
Measured: 30 minutes before colonoscopy
Anxiety (Visual Analog Scale-Anxiety)
Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.
Measured: 5-10 minutes before colonoscopy
Systolic blood pressure
In the measurement of vital signs of individuals, devices that measure digital blood pressure will be used by applying the necessary hygiene rules at patient transitions.
Measured: 30 minutes before colonoscopy
Systolic blood pressure
In the measurement of vital signs of individuals, devices that measure digital blood pressure will be used by applying the necessary hygiene rules at patient transitions.
Measured: 5-10 minutes before colonoscopy
Diastolic blood pressure
In the measurement of vital signs of individuals, devices that measure digital blood pressure will be used by applying the necessary hygiene rules at patient transitions.
Measured: 30 minutes before colonoscopy
Diastolic blood pressure
In the measurement of vital signs of individuals, devices that measure digital blood pressure will be used by applying the necessary hygiene rules at patient transitions.
Measured: 5-10 minutes before colonoscopy
Heart rate
In the measurement of vital signs of individuals, devices that measure digital pulse will be used by applying the necessary hygiene rules at patient transitions.
Measured: 5-10 minutes before colonoscopy
Heart rate
In the measurement of vital signs of individuals, devices that measure digital pulse will be used by applying the necessary hygiene rules at patient transitions.
Measured: 30 minutes before colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start25 Nov 2023
- Primary completion30 May 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 30 minutes before colonoscopy, the patients' systolic, diastolic blood pressure and heart rate were measured and recorded. Anxiety levels were determined with VAS. Afterwards, the patients were shown videos using virtual reality glasses. 5-10 minutes before the colonoscopy, the patients' systolic, diastolic blood pressure and heart rate were measured and recorded. Anxiety levels were determined with VAS.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Cansu Yeniğün, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407531
- Sponsor's protocol ID
- VRG208
- Status last verified
- Jul 2024
- First submitted
- 3 May 2024
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yenigun Akbulut SC, Alptekin HM, Unver S. Effectiveness of Virtual Reality Intervention on Anxiety and Vital Signs of Patients Before Colonoscopy: A Randomised Controlled Study. Nurs Open. 2026 Mar;13(3):e70465. doi: 10.1002/nop2.70465.
PubMed 41840460
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effect of Virtual Reality Application on Patient's Anxiety and Vital Signs Before Colonoscopy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06407531
- Acronym / sponsor ID
- VRG208
- Conditions
- Colonoscopy
- Keywords
- virtual reality glasses, surgical nursing, colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 25 Nov 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 9 May 2024 (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 was planned to examine the effect of virtual reality application on the patient's anxiety and vital signs before colonoscopy. The hypotheses of the research are as follows:
H1: Virtual reality application before colonoscopy has an effect on patients' anxiety and vital signs.
H0: Virtual reality application before colonoscopy has no effect on patients' anxiety and vital signs.
Before colonoscopy, patients in the study group will be asked to watch videos using virtual reality glasses.
Detailed description
After obtaining the ethics committee and institutional permission for the research, the researcher was taken to the hospital for the colonoscopy procedure.
He/she will introduce himself/herself to the patients and explain the purpose of the research. Patients who volunteered to participate in the study Informed consent will be obtained. Data regarding the socio-demographic characteristics of the patients included in the patient introduction form The patient will be interviewed face to face, and data regarding the patients' clinical characteristics will be recorded from the patient file. colonoscopy Data will begin to be collected from the first patient to undergo the procedure. Anxiety and life assessment with VAS 30 minutes before the procedure The findings will be considered. According to the randomization, the patient in the virtual reality glasses group was first asked by the researcher.
It will be explained to the patient that he will wear the glasses for 30 minutes and watch a video before the procedure. By researcher 30 When the minute is up, the patient will be informed and asked to remove the glasses. No intervention was made to the patient in the control group.
It will not be done. Anxiety and vital signs were measured with VAS 5-10 minutes before the procedure began in all patient groups.
will be looked into. After each patient use, the virtual reality glasses will be cleaned and dried with alcohol-based cleaning material.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 30 minutes before colonoscopy, the patients' systolic, diastolic blood pressure and heart rate were measured and recorded. Anxiety levels were determined with VAS. Afterwards, the patients were shown videos using virtual reality glasses. 5-10 minutes before the colonoscopy, the patients' systolic, diastolic blood pressure and heart rate were measured and recorded. Anxiety levels were determined with VAS.
| Arm | Type | Receives |
|---|---|---|
| VR-G | Experimental | Other: VR-GThe patient will wear virtual glasses and watch a video 30 minutes before the procedure. |
| Control | No intervention | –No intervention will be performed on control group patients and the standard care protocol of the clinic will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Volunteering to participate in the research,
- Being literate,
- Be 18 years or older.
Key exclusion criteria (4 listed)
- Performing colonoscopy at the same time as endoscopy,
- Using any analgesic or anxiolytic,
- Having a visual or hearing impairment,
- Performing an emergency colonoscopy.
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 |
|---|---|---|
| VR-GPatients watched videos with virtual glasses before undergoing colonoscopy | Other | VR-G |
Primary outcome
Anxiety (Visual Analog Scale-Anxiety)
Time frame: 30 minutes before colonoscopy
Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.
Anxiety (Visual Analog Scale-Anxiety)
Time frame: 5-10 minutes before colonoscopy
Patients' anxiety will be evaluated (0-10 point). Grading is made with a 10 cm long horizontal or vertical ruler on the scale and "0" means no anxiety and "10" means the most severe anxiety. In the application, the patient was asked to mark the intensity of pain he felt on the ruler and the value was measured and recorded.
Systolic blood pressure
Time frame: 30 minutes before colonoscopy
In the measurement of vital signs of individuals, devices that measure digital blood pressure will be used by applying the necessary hygiene rules at patient transitions.
Systolic blood pressure
Time frame: 5-10 minutes before colonoscopy
In the measurement of vital signs of individuals, devices that measure digital blood pressure will be used by applying the necessary hygiene rules at patient transitions.
Diastolic blood pressure
Time frame: 30 minutes before colonoscopy
In the measurement of vital signs of individuals, devices that measure digital blood pressure will be used by applying the necessary hygiene rules at patient transitions.
Diastolic blood pressure
Time frame: 5-10 minutes before colonoscopy
In the measurement of vital signs of individuals, devices that measure digital blood pressure will be used by applying the necessary hygiene rules at patient transitions.
Heart rate
Time frame: 5-10 minutes before colonoscopy
In the measurement of vital signs of individuals, devices that measure digital pulse will be used by applying the necessary hygiene rules at patient transitions.
Heart rate
Time frame: 30 minutes before colonoscopy
In the measurement of vital signs of individuals, devices that measure digital pulse will be used by applying the necessary hygiene rules at patient transitions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Derived from this study: PubMed 41840460Yenigun Akbulut SC, Alptekin HM, Unver S. Effectiveness of Virtual Reality Intervention on Anxiety and Vital Signs of Patients Before Colonoscopy: A Randomised Controlled Study. Nurs Open. 2026 Mar;13(3):e70465. doi: 10.1002/nop2.70465.
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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 VR-G in people with Colonoscopy, run by Akdeniz 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 18 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Anxiety (Visual Analog Scale-Anxiety) (time frame: 30 minutes before colonoscopy). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06407531, which also lists 1 linked publication.
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 18 May 2026.