PainNCT06718504
The Effect of Virtual Reality Glasses During Endoscopy
A study testing Virtual Reality Glasses in people with Pain and Anxiety, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Upper gastrointestinal endoscopy is an invasive procedure used to diagnose and treat pathologies in the gastrointestinal mucosa. Since it is an invasive procedure, it can cause anxiety in patients before and pain during the procedure. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Anxiety, Gastro-Intestinal Disorder
- What is being tested?
- Virtual Reality Glasses
- 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
- 31 Jul 2024to 2 Dec 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To have an upper gastrointestinal endoscopy for the first time
- To be performed an upper GI endoscopy without sedation
- To be between the ages of 18-75
- To be willing to participate in research
Who cannot join
- To use analgesic or anesthetic drugs before or during the procedure
- To use antidepressants, anxiolytic and sedative drugs
- To have communication difficulties and mental disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality Glasses on Pain, Anxiety, and Comfort During Upper Gastrointestinal System Endoscopy: Randomized Controlled Trial
Upper gastrointestinal endoscopy is an invasive procedure used to diagnose and treat pathologies in the gastrointestinal mucosa. Since it is an invasive procedure, it can cause anxiety in patients before and pain during the procedure. Virtual reality glasses are an effective method used to reduce the pain and anxiety levels of patients during painful procedures. This study aimed to evaluate the effects of virtual reality glasses on pain, anxiety, and comfort in patients undergoing upper gastrointestinal endoscopy without sedation.
Read the detailed description
This single-center randomized controlled parallel group study was conducted with 60 patients who underwent upper gastrointestinal endoscopy at the Endoscopy Unit of a training and research hospital in Istanbul. Patients in the virtual reality glasses group (n=30) watched videos of their preferred relaxing nature settings or videos without any violent content during the procedure. Patients in the control group (n=30) received no intervention. Data were collected using the Patient Information Form, Visual Analog Scale (for pain and comfort) and State Anxiety Inventory. Pain, comfort and anxiety levels of patients were assessed five minutes before and five minutes after the procedure.
- Conditions
- Pain, Anxiety, Gastro-Intestinal Disorder
- Being tested
- Virtual Reality Glasses
- Keywords
- Pain, Anxiety, Comfort, Endoscopy, Virtual Reality Glasses
- Medical subject headings
- Pain, Anxiety Disorders, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality GlassesDevice
Virtual reality is a method that can be used to distract and prepare patients for medical procedures. Virtual reality is a computer-generated environment where three-dimensional interaction is possible. It is an advanced technology that allows an individual to move into a virtual environment and focus their attention on other thoughts, allowing them to pay less attention to pain and anxiety. In this study, the virtual reality glasses were put on for the intervention group five minutes before the procedure began and were kept on until the procedure was completed. The virtual reality glasses showed the patient-selected images of a relaxing nature setting or images without any violent content.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | During the procedure, patients in the intervention group watched videos of their choice, either in a relaxing natural setting or without any violent content, using virtual reality glasses. Receives: Device: Virtual Reality Glasses |
| Control Group | No intervention | No intervention was applied to the patients in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on pain intensity as measured by Visual Analog Scale
The average score change on pain intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure pain intensity. The scale is a measuring tool with length of 0-10 cm. High scores on the scale indicate that pain intensity is high.
Measured: five minutes before endoscopy and five minutes after endoscopy
Secondary outcomes (1)
Change on anxiety level as measured by State-Trait Anxiety Inventory
The average score change on anxiety level as measured by State-Trait Anxiety Inventory. This scale in used to measure anxiety. The scores on the scale ranges from 20 to 80. The high scores on the scale indicate that anxiety is high.
Measured: five minutes before endoscopy and five minutes after endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start31 Jul 2024
- Primary completion10 Oct 2024
- Study completion2 Dec 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 PainStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a single-center parallel-group randomized controlled clinical trial. Participants who met the inclusion criteria for the study were divided into two equal groups: the intervention group (n=30) and the control group (n=30). according to the computer-based randomization table.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Gezginci, Saglik Bilimleri Universitesi
- Investigators
- Elif Gezginci Akpınar, Assoc Prof, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06718504
- Sponsor's protocol ID
- 167
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gezginci Akpinar E, Cabi Z. The Effect of Virtual Reality Goggles on Pain, Anxiety, and Comfort During Upper Gastrointestinal Endoscopy: A Randomized Controlled Study. Gastroenterol Nurs. 2026 Jan-Feb 01;49(1):9-16. doi: 10.1097/SGA.0000000000000919. Epub 2026 Jan 23.
PubMed 41576331
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses on Pain, Anxiety, and Comfort During Upper Gastrointestinal System Endoscopy: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06718504
- Acronym / sponsor ID
- 167
- Conditions
- Pain, Anxiety, Gastro-Intestinal Disorder
- Keywords
- Pain, Anxiety, Comfort, Endoscopy, Virtual Reality Glasses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 2 Dec 2024 (actual)
- First posted
- 5 Dec 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.
Upper gastrointestinal endoscopy is an invasive procedure used to diagnose and treat pathologies in the gastrointestinal mucosa. Since it is an invasive procedure, it can cause anxiety in patients before and pain during the procedure. Virtual reality glasses are an effective method used to reduce the pain and anxiety levels of patients during painful procedures. This study aimed to evaluate the effects of virtual reality glasses on pain, anxiety, and comfort in patients undergoing upper gastrointestinal endoscopy without sedation.
Detailed description
This single-center randomized controlled parallel group study was conducted with 60 patients who underwent upper gastrointestinal endoscopy at the Endoscopy Unit of a training and research hospital in Istanbul. Patients in the virtual reality glasses group (n=30) watched videos of their preferred relaxing nature settings or videos without any violent content during the procedure. Patients in the control group (n=30) received no intervention. Data were collected using the Patient Information Form, Visual Analog Scale (for pain and comfort) and State Anxiety Inventory. Pain, comfort and anxiety levels of patients were assessed five minutes before and five minutes after the procedure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a single-center parallel-group randomized controlled clinical trial. Participants who met the inclusion criteria for the study were divided into two equal groups: the intervention group (n=30) and the control group (n=30). according to the computer-based randomization table.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Device: Virtual Reality GlassesDuring the procedure, patients in the intervention group watched videos of their choice, either in a relaxing natural setting or without any violent content, using virtual reality glasses. |
| Control Group | No intervention | –No intervention was applied to the patients in the control group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- To have an upper gastrointestinal endoscopy for the first time
- To be performed an upper GI endoscopy without sedation
- To be between the ages of 18-75
- To be willing to participate in research
Key exclusion criteria (3 listed)
- To use analgesic or anesthetic drugs before or during the procedure
- To use antidepressants, anxiolytic and sedative drugs
- To have communication difficulties and mental disability
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 GlassesVirtual reality is a method that can be used to distract and prepare patients for medical procedures. Virtual reality is a computer-generated environment where three-dimensional interaction is possible. It is an advanced technology that allows an individual to move into a virtual environment and focus their attention on other thoughts, allowing them to pay less attention to pain and anxiety. In this study, the virtual reality glasses were put on for the intervention group five minutes before the procedure began and were kept on until the procedure was completed. The virtual reality glasses showed the patient-selected images of a relaxing nature setting or images without any violent content. | Device | Intervention Group |
Primary outcome
Change on pain intensity as measured by Visual Analog Scale
Time frame: five minutes before endoscopy and five minutes after endoscopy
The average score change on pain intensity as measured by Visual Analog Scale. This scale is an unidimensional measure commonly used to measure pain intensity. The scale is a measuring tool with length of 0-10 cm. High scores on the scale indicate that pain intensity is high.
1 secondary outcome
Change on anxiety level as measured by State-Trait Anxiety Inventory
Time frame: five minutes before endoscopy and five minutes after endoscopy
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 5 Dec 2024.
- Derived from this study: PubMed 41576331Gezginci Akpinar E, Cabi Z. The Effect of Virtual Reality Goggles on Pain, Anxiety, and Comfort During Upper Gastrointestinal Endoscopy: A Randomized Controlled Study. Gastroenterol Nurs. 2026 Jan-Feb 01;49(1):9-16. doi: 10.1097/SGA.0000000000000919. Epub 2026 Jan 23.
- 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.
Elif Gezginci Akpınar, Assoc Prof principal investigator
Saglik Bilimleri Universitesi
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 in people with Pain and Anxiety, run by Saglik Bilimleri Universitesi 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 3 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 5 Dec 2024. 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?
Change on pain intensity as measured by Visual Analog Scale (time frame: five minutes before endoscopy and five minutes after endoscopy). 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 NCT06718504, 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 5 Dec 2024.