Patient Anxiety During Upper Gastrointestinal EndoscopyVirtualNCT07848009
Artificial Intelligence-Based Virtual Reality on Patient With Upper Gastrointestinal Endoscopy
A study testing Artificial Intelligence-Based Virtual Reality Relaxation in people with Patient Anxiety During Upper Gastrointestinal Endoscopy, run by Al-Zaytoonah University of Jordan at 1 site in Jordan.
Trial summary
This randomized controlled trial evaluates whether an artificial intelligence-based virtual reality (AI-VR) relaxation intervention can improve patient outcomes during upper gastrointestinal endoscopy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Patient Anxiety During Upper Gastrointestinal Endoscopy
- What is being tested?
- Artificial Intelligence-Based Virtual Reality Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteJordan
- Study dates
- 4 Jan 2026to 7 Mar 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be eligible for inclusion if they:
- Are within the prespecified age range for the study ([insert minimum and maximum age
- Are scheduled to undergo elective upper gastrointestinal endoscopy.
- Are able to understand the study procedures and communicate effectively.
- Are willing to participate in the study and provide informed consent.
Who cannot join
- Participants will be excluded if they:
- Have a condition that prevents them from safely participating in the virtual reality intervention.
- Have significant visual, auditory, cognitive, or neurological impairment that would interfere with the use of the virtual reality intervention or completion of the study assessments.
- Have previously participated in this study.
- Are unable or unwilling to provide informed consent.
- Require an urgent or emergency upper gastrointestinal endoscopy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Artificial Intelligence-Based Virtual Reality on Patient-Reported Outcomes During Upper Gastrointestinal Endoscopy: A Randomized Controlled Trial
This randomized controlled trial evaluates whether an artificial intelligence-based virtual reality (AI-VR) relaxation intervention can improve patient outcomes during upper gastrointestinal endoscopy. Patients undergoing elective upper gastrointestinal endoscopy will be randomly assigned in a 1:1 ratio to either an AI-VR intervention group or a routine-care control group. Participants in the intervention group will receive a 10-15-minute AI-VR relaxation session immediately before the endoscopy, while participants in the control group will receive routine care. The study will assess patients' anxiety, pain perception, physiological parameters, and satisfaction in relation to the endoscopy procedure. The findings will help determine whether AI-VR can improve patient comfort and the overall endoscopy experience.
Read the detailed description
Upper gastrointestinal endoscopy is an important diagnostic and therapeutic procedure; however, patients may experience anxiety, pain, discomfort, and physiological changes before and during the procedure. These experiences may negatively affect patient comfort and satisfaction. This study was designed to evaluate the effect of an artificial intelligence-based virtual reality (AI-VR) relaxation intervention on patient-reported and physiological outcomes among patients undergoing elective upper gastrointestinal endoscopy.
This study uses a randomized controlled trial design. Eligible patients undergoing elective upper gastrointestinal endoscopy will be randomly assigned in a 1:1 ratio to either an intervention group or a routine-care control group. The intervention group will receive a 10-15-minute AI-VR relaxation session immediately before undergoing upper gastrointestinal endoscopy. The control group will receive routine care according to the usual clinical practice.
The AI-VR intervention is intended to provide a relaxation experience before the endoscopic procedure. Patient outcomes will be assessed using validated measures of anxiety and pain, together with physiological parameters and patient satisfaction. Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI), pain perception will be assessed using the Visual Analog Scale (VAS), and patient satisfaction will be assessed using the Patient Satisfaction Questionnaire (PSQ). Physiological parameters will also be assessed at the prespecified assessment time points.
The primary purpose of the study is to determine whether the AI-VR intervention improves patient outcomes during upper gastrointestinal endoscopy compared with routine care. Outcomes of interest include anxiety level, pain perception, physiological responses, and patient satisfaction.
Randomization will be performed using a computer-generated random sequence. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes. Eligible participants will be enrolled after confirmation of eligibility and informed consent and will then be assigned to their respective study groups according to the concealed allocation sequence.
Data will be analyzed using IBM SPSS Statistics version 26.0. Appropriate statistical tests will be used to compare outcomes between the intervention and control groups and to examine relationships among anxiety, pain, satisfaction, and other study variables.
The study is intended to provide evidence regarding the potential role of AI-based virtual reality as a non-pharmacological intervention for reducing anxiety and discomfort and improving physiological responses and satisfaction among patients undergoing upper gastrointestinal endoscopy.
- Being tested
- Artificial Intelligence-Based Virtual Reality Relaxation
- Keywords
- Patient Anxiety Pain Upper Gastrointestinal Endoscopy Artificial Intelligence Virtual Reality AI-Based Virtual Reality Anxiety Management Pain Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence-Based Virtual Reality RelaxationBehavioural
Artificial Intelligence-Based Virtual Reality Relaxation
| Study group | Role | What they receive |
|---|---|---|
| AI-Based Virtual Reality Group | Experimental | Artificial Intelligence-Based Virtual Reality Relaxation Receives: Behavioral: Artificial Intelligence-Based Virtual Reality Relaxation |
| Routine Care Control Group | No intervention | non |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Anxiety During Upper Gastrointestinal Endoscopy
Patient anxiety will be assessed using the State-Trait Anxiety Inventory (STAI). Anxiety scores will be compared between the artificial intelligence-based virtual reality intervention group and the routine-care control group to evaluate the effect of the intervention on patient anxiety during upper gastrointestinal endoscopy. The STAI consists of 20 items for assessing state anxiety, with total scores ranging from 20 to 80; higher scores indicate greater anxiety.
Measured: Anxiety (STAI) Baseline (pre-intervention) and immediately after the endoscopy procedure Pain intensity (VAS) Immediately after the endoscopy procedure Patient satisfaction (PSQ) Immediately after the endoscopy procedure Physiological parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start4 Jan 2026
- Primary completion5 Jan 2026
- Study completion7 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Anxiety During Upper Gastrointestinal EndoscopyStudies of the same condition, open and under way.
- 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
- This is a two-arm, parallel-group randomized controlled trial. Eligible participants undergoing elective upper gastrointestinal endoscopy will be randomly assigned in a 1:1 ratio to either an artificial intelligence-based virtual reality intervention group or a routine-care control group. The intervention group will receive a 10-15-minute AI-based virtual reality relaxation session before upper gastrointestinal endoscopy, while the control group will receive routine care.
- Masking
- None (open label)
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Zaytoonah University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Abdelfatah Shokr, Al-Zaytoonah University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07848009
- Sponsor's protocol ID
- 1000/4/3/196/26
- Acronym
- Virtual
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study did not establish a data-sharing arrangement for individual-level participant data. The data contain potentially identifiable participant information and will be retained securely by the research team in accordance with applicable ethical and institutional requirements. De-identified aggregate results will be reported in publications arising from the study.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Artificial Intelligence-Based Virtual Reality on Patient-Reported Outcomes During Upper Gastrointestinal Endoscopy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07848009
- Acronym / sponsor ID
- Virtual / 1000/4/3/196/26
- Keywords
- Patient Anxiety Pain Upper Gastrointestinal Endoscopy Artificial Intelligence Virtual Reality AI-Based Virtual Reality Anxiety Management Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Al-Zaytoonah University of JordanUniversity, hospital or other
- Study start
- 4 Jan 2026 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 7 Mar 2026 (actual)
- First posted
- 29 Sep 2026 (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 randomized controlled trial evaluates whether an artificial intelligence-based virtual reality (AI-VR) relaxation intervention can improve patient outcomes during upper gastrointestinal endoscopy. Patients undergoing elective upper gastrointestinal endoscopy will be randomly assigned in a 1:1 ratio to either an AI-VR intervention group or a routine-care control group. Participants in the intervention group will receive a 10-15-minute AI-VR relaxation session immediately before the endoscopy, while participants in the control group will receive routine care. The study will assess patients' anxiety, pain perception, physiological parameters, and satisfaction in relation to the endoscopy procedure. The findings will help determine whether AI-VR can improve patient comfort and the overall endoscopy experience.
Detailed description
Upper gastrointestinal endoscopy is an important diagnostic and therapeutic procedure; however, patients may experience anxiety, pain, discomfort, and physiological changes before and during the procedure. These experiences may negatively affect patient comfort and satisfaction. This study was designed to evaluate the effect of an artificial intelligence-based virtual reality (AI-VR) relaxation intervention on patient-reported and physiological outcomes among patients undergoing elective upper gastrointestinal endoscopy.
This study uses a randomized controlled trial design. Eligible patients undergoing elective upper gastrointestinal endoscopy will be randomly assigned in a 1:1 ratio to either an intervention group or a routine-care control group. The intervention group will receive a 10-15-minute AI-VR relaxation session immediately before undergoing upper gastrointestinal endoscopy. The control group will receive routine care according to the usual clinical practice.
The AI-VR intervention is intended to provide a relaxation experience before the endoscopic procedure. Patient outcomes will be assessed using validated measures of anxiety and pain, together with physiological parameters and patient satisfaction. Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI), pain perception will be assessed using the Visual Analog Scale (VAS), and patient satisfaction will be assessed using the Patient Satisfaction Questionnaire (PSQ). Physiological parameters will also be assessed at the prespecified assessment time points.
The primary purpose of the study is to determine whether the AI-VR intervention improves patient outcomes during upper gastrointestinal endoscopy compared with routine care. Outcomes of interest include anxiety level, pain perception, physiological responses, and patient satisfaction.
Randomization will be performed using a computer-generated random sequence. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes. Eligible participants will be enrolled after confirmation of eligibility and informed consent and will then be assigned to their respective study groups according to the concealed allocation sequence.
Data will be analyzed using IBM SPSS Statistics version 26.0. Appropriate statistical tests will be used to compare outcomes between the intervention and control groups and to examine relationships among anxiety, pain, satisfaction, and other study variables.
The study is intended to provide evidence regarding the potential role of AI-based virtual reality as a non-pharmacological intervention for reducing anxiety and discomfort and improving physiological responses and satisfaction among patients undergoing upper gastrointestinal endoscopy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a two-arm, parallel-group randomized controlled trial. Eligible participants undergoing elective upper gastrointestinal endoscopy will be randomly assigned in a 1:1 ratio to either an artificial intelligence-based virtual reality intervention group or a routine-care control group. The intervention group will receive a 10-15-minute AI-based virtual reality relaxation session before upper gastrointestinal endoscopy, while the control group will receive routine care.
| Arm | Type | Receives |
|---|---|---|
| AI-Based Virtual Reality Group | Experimental | Behavioral: Artificial Intelligence-Based Virtual Reality RelaxationArtificial Intelligence-Based Virtual Reality Relaxation |
| Routine Care Control Group | No intervention | –non |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Are within the prespecified age range for the study ([insert minimum and maximum age
- Are scheduled to undergo elective upper gastrointestinal endoscopy.
- Are able to understand the study procedures and communicate effectively.
- Are willing to participate in the study and provide informed consent.
Key exclusion criteria (6 listed)
- Have a condition that prevents them from safely participating in the virtual reality intervention.
- Have significant visual, auditory, cognitive, or neurological impairment that would interfere with the use of the virtual reality intervention or completion of the study assessments.
- Have previously participated in this study.
- Are unable or unwilling to provide informed consent.
- Require an urgent or emergency upper gastrointestinal endoscopy.
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 |
|---|---|---|
| Artificial Intelligence-Based Virtual Reality RelaxationArtificial Intelligence-Based Virtual Reality Relaxation | Behavioural | AI-Based Virtual Reality Group |
Primary outcome
Patient Anxiety During Upper Gastrointestinal Endoscopy
Time frame: Anxiety (STAI) Baseline (pre-intervention) and immediately after the endoscopy procedure Pain intensity (VAS) Immediately after the endoscopy procedure Patient satisfaction (PSQ) Immediately after the endoscopy procedure Physiological parameters
Patient anxiety will be assessed using the State-Trait Anxiety Inventory (STAI). Anxiety scores will be compared between the artificial intelligence-based virtual reality intervention group and the routine-care control group to evaluate the effect of the intervention on patient anxiety during upper gastrointestinal endoscopy. The STAI consists of 20 items for assessing state anxiety, with total scores ranging from 20 to 80; higher scores indicate greater anxiety.
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 29 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study did not establish a data-sharing arrangement for individual-level participant data. The data contain potentially identifiable participant information and will be retained securely by the research team in accordance with applicable ethical and institutional requirements. De-identified aggregate results will be reported in publications arising from the study.
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 Artificial Intelligence-Based Virtual Reality Relaxation in people with Patient Anxiety During Upper Gastrointestinal Endoscopy, run by Al-Zaytoonah University of Jordan at 1 site in Jordan.
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 5 inclusion and 6 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 29 Sep 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 Jordan. 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?
Patient Anxiety During Upper Gastrointestinal Endoscopy (time frame: Anxiety (STAI) Baseline (pre-intervention) and immediately after the endoscopy procedure Pain intensity (VAS) Immediately after the endoscopy procedure Patient satisfaction (PSQ) Immediately after the endoscopy procedure Physiological parameters). 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 29 Sep 2026.