AnxietyNCT05585749
Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients
A study testing Virtual Reality Based Relaxation Program in people with Anxiety, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
In contemporary medicine, endoscopic procedures are often regarded as the gold standard for the diagnosis and treatment of gastrointestinal illnesses due to the essential role they play in these processes. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Virtual Reality Based Relaxation Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Sep 2022to 30 Jun 2023
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Eligible individuals were adults aged 18 or older, capable of effective communication, and scheduled for non-sedated oral gastroduodenoscopy (OGD).
Exclusion criteria included emergency endoscopy, neurological conditions (e.g., migraine, vertigo, chronic headaches), or sensory impairments affecting hearing or vision.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients
In contemporary medicine, endoscopic procedures are often regarded as the gold standard for the diagnosis and treatment of gastrointestinal illnesses due to the essential role they play in these processes. Endoscopy is a minimally invasive procedure that allows direct visualization of the gastrointestinal tract using a flexible, camera-equipped instrument.However, due to their invasive nature, these methods pose certain challenges for both healthcare professionals and patients. In particular, the physical discomfort and pain experienced during the procedure can lead to a negative attitude toward the process in patients, which can indirectly affect the success of the procedure .Despite the fact that a number of studies have examined the impact of virtual reality applications on pain and anxiety during endoscopy, the conclusions remain inconsistent. Moreover, relatively few studies have assessed physiological signs of anxiety. Therefore, uncertainties remain regarding the generalizability of existing findings. The present study aimed to examine the effect of virtual reality application on pain, anxiety, and physiological parameters in patients undergoing endoscopy.
- Conditions
- Anxiety
- Being tested
- Virtual Reality Based Relaxation Program
- Keywords
- Virtual Reality, Anxiety, Pain, Endoscopy Patients
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Based Relaxation ProgramOther
Virtual Reality Based Relaxation Program
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Based Relaxation Program | Experimental | Virtual Reality Based Relaxation Program Receives: Other: Virtual Reality Based Relaxation Program |
| Control group | No intervention | Routine maintenance will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Visual Analog Scale is used to convert some values that cannot be measured numerically into digital. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing.0 points means no pain, 100 points means a lot of pain
Measured: 1 hours later
Anxiety Assessment Scale
Patients will be asked to show their anxiety levels before and after the procedure on a 10 cm long horizontal line. Line has 0 at the beginning and 10 at the end. 10 means very extreme anxiety and 0 means no anxiety.
Measured: 1 hours later
Physiological Symptoms of Anxiety Follow-up Form
This form was created by the researcher to record blood pressure, heart rate, respiratory rate and peripheral oxygen saturation value.
Measured: 1 hours later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start5 Sep 2022
- Primary completion30 Jan 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Model description
- Virtual Reality Based Relaxation Program
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülcan Bahçecioğlu Turan, Ataturk University
- Investigators
- Gülcan Bahçecioğlu Turan, PhD, Study chair, Firat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05585749
- Sponsor's protocol ID
- 2022/ 04 - 22
- Status last verified
- Dec 2025
- First submitted
- 22 Sep 2022
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients
- ClinicalTrials.gov ID
- NCT05585749
- Acronym / sponsor ID
- 2022/ 04 - 22
- Conditions
- Anxiety
- Keywords
- Virtual Reality, Anxiety, Pain, Endoscopy Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 19 Oct 2022 (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.
In contemporary medicine, endoscopic procedures are often regarded as the gold standard for the diagnosis and treatment of gastrointestinal illnesses due to the essential role they play in these processes. Endoscopy is a minimally invasive procedure that allows direct visualization of the gastrointestinal tract using a flexible, camera-equipped instrument.However, due to their invasive nature, these methods pose certain challenges for both healthcare professionals and patients. In particular, the physical discomfort and pain experienced during the procedure can lead to a negative attitude toward the process in patients, which can indirectly affect the success of the procedure .Despite the fact that a number of studies have examined the impact of virtual reality applications on pain and anxiety during endoscopy, the conclusions remain inconsistent. Moreover, relatively few studies have assessed physiological signs of anxiety. Therefore, uncertainties remain regarding the generalizability of existing findings. The present study aimed to examine the effect of virtual reality application on pain, anxiety, and physiological parameters in patients undergoing endoscopy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Virtual Reality Based Relaxation Program
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Based Relaxation Program | Experimental | Other: Virtual Reality Based Relaxation ProgramVirtual Reality Based Relaxation Program |
| Control group | No intervention | –Routine maintenance will be applied. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 Based Relaxation ProgramVirtual Reality Based Relaxation Program | Other | Virtual Reality Based Relaxation Program |
Primary outcome
Visual Analog Scale
Time frame: 1 hours later
Visual Analog Scale is used to convert some values that cannot be measured numerically into digital. Two end definitions of the parameter to be evaluated are written at the two ends of a 100 mm line and the patient is asked to indicate where on this line their situation is appropriate by drawing a line or by placing a dot or pointing.0 points means no pain, 100 points means a lot of pain
Anxiety Assessment Scale
Time frame: 1 hours later
Patients will be asked to show their anxiety levels before and after the procedure on a 10 cm long horizontal line. Line has 0 at the beginning and 10 at the end. 10 means very extreme anxiety and 0 means no anxiety.
Physiological Symptoms of Anxiety Follow-up Form
Time frame: 1 hours later
This form was created by the researcher to record blood pressure, heart rate, respiratory rate and peripheral oxygen saturation value.
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 9 Dec 2025.
- Individual participant dataSharing planned: No
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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.
Gülcan Bahçecioğlu Turan, PhD study chair
Firat University
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 Based Relaxation Program in people with Anxiety, run by Ataturk 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?
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 9 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?
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?
Visual Analog Scale (time frame: 1 hours later). 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 9 Dec 2025.