Upper Gastrointestinal DisordersNCT07745959
Effect of Virtual Reality Before Upper Gastrointestinal Endoscopy on Preprocedural Anxiety, Psychological Readiness, and Postprocedural Satisfaction
A study testing Virtual Reality and Standard Preprocedural Care in people with Upper Gastrointestinal Disorders, run by Ardahan University at 1 site in Turkey (Türkiye).
Trial summary
Objective: This study aims to evaluate the effect of virtual reality applied before upper gastrointestinal endoscopy on preprocedural anxiety, psychological readiness, and postprocedural satisfaction. Methods: This randomized controlled trial will be conducted in the Endoscopy Unit of Kelkit State Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Disorders
- What is being tested?
- Virtual Reality and Standard Preprocedural Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2026to 31 Mar 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older
- Scheduled to undergo upper gastrointestinal endoscopy
- Able to understand and communicate in Turkish
- Willing to participate in the study
- Providing written informed consent
Who cannot join
- Presence of a diagnosed psychiatric or neurological disorder that may interfere with participation
- Presence of a visual, hearing, head, face, or eye condition that prevents the use of a virtual reality headset
- History of severe vertigo, motion sickness, or balance disorder
- Development of severe dizziness, nausea, eye strain, or discomfort during the virtual reality intervention
- Refusal to participate or withdrawal from the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Atatürk University Research Hospital
Erzurum, 25400
DERYA ŞİMŞEKLİ, PhD, 05545965789, deryasimsekli@ardahan.edu.tr
About this study
Official title: Effect of Virtual Reality Before Upper Gastrointestinal Endoscopy on Preprocedural Anxiety, Psychological Readiness, and Postprocedural Satisfaction: A Randomized Controlled Trial
Objective: This study aims to evaluate the effect of virtual reality applied before upper gastrointestinal endoscopy on preprocedural anxiety, psychological readiness, and postprocedural satisfaction.
Methods: This randomized controlled trial will be conducted in the Endoscopy Unit of Kelkit State Hospital. A total of 64 patients scheduled to undergo upper gastrointestinal endoscopy will be enrolled and randomly assigned in a 1:1 ratio to either the virtual reality intervention group or the control group. Participants in the intervention group will receive a virtual reality application before the endoscopy procedure, whereas participants in the control group will receive standard care. Data will be collected using the Endoscopy Patient Information Form, the State Anxiety Inventory (STAI-I), a single-item Psychological Readiness Assessment, and a single-item Postprocedural Satisfaction Assessment. Anxiety and psychological readiness will be evaluated before the procedure, and patient satisfaction will be assessed immediately after the procedure.
Expected Results: It is anticipated that the virtual reality intervention will reduce preprocedural anxiety, improve psychological readiness, and increase postprocedural satisfaction compared with standard care.
Read the detailed description
Upper gastrointestinal endoscopy is one of the most frequently performed diagnostic procedures for evaluating disorders of the upper gastrointestinal tract. Although it is generally considered safe, many patients experience considerable anxiety before the procedure. High levels of preprocedural anxiety may negatively affect psychological readiness, reduce patient cooperation, impair the overall procedural experience, and decrease satisfaction with care. Therefore, effective non-pharmacological interventions that improve the patient's psychological state before endoscopy are needed.
Virtual reality (VR) is an immersive technology that provides visual and auditory stimulation, allowing individuals to become engaged in a relaxing virtual environment and divert their attention from stressful situations. Previous studies have demonstrated that virtual reality can reduce anxiety, pain, and physiological stress during various medical procedures. However, evidence regarding the effectiveness of virtual reality when applied before upper gastrointestinal endoscopy, particularly its effects on psychological readiness and postprocedural satisfaction, remains limited.
This randomized controlled trial aims to evaluate the effect of virtual reality applied before upper gastrointestinal endoscopy on preprocedural anxiety, psychological readiness, and postprocedural satisfaction. The study will be conducted in the Endoscopy Unit of Kelkit State Hospital. A total of 64 patients who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to either the virtual reality intervention group or the control group using block randomization.
Participants in the intervention group will receive a virtual reality application before the endoscopy procedure in addition to standard care. Participants in the control group will receive standard preprocedural care only. Data will be collected using the Endoscopy Patient Information Form, the State Anxiety Inventory (STAI-I), a single-item Psychological Readiness Assessment, and a single-item Postprocedural Satisfaction Assessment. Anxiety and psychological readiness will be evaluated before the procedure, while postprocedural satisfaction will be assessed immediately after completion of the endoscopy.
The findings of this study are expected to provide evidence regarding the effectiveness of virtual reality as a simple, non-invasive, and low-cost intervention for reducing preprocedural anxiety, improving patients' psychological readiness for upper gastrointestinal endoscopy, and enhancing satisfaction with the procedure. The results may contribute to the development of evidence-based nursing interventions and improve patient-centered care in endoscopy units.
- Conditions
- Upper Gastrointestinal Disorders
- Being tested
- Virtual Reality, Standard Preprocedural Care
- Keywords
- Virtual Reality, Upper Gastrointestinal Endoscopy, Preprocedural Anxiety, Psychological Readiness, Patient Satisfaction, State Anxiety, Endoscopy
- Medical subject headings
- Gastrointestinal Diseases, Patient Satisfaction, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Participants will receive the institution's standard preprocedural care before upper gastrointestinal endoscopy without the virtual reality intervention.
Standard Preprocedural CareOther
Participants will receive the institution's routine preprocedural care before upper gastrointestinal endoscopy without virtual reality.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants will receive a virtual reality intervention before upper gastrointestinal endoscopy in addition to standard preprocedural care. The virtual reality application will be administered before the endoscopy procedure using a virtual reality headset. Receives: Device: Virtual Reality |
| Standard Care Group | Active comparator | Participants will receive a virtual reality intervention using a virtual reality headset before upper gastrointestinal endoscopy. The intervention is designed to reduce preprocedural anxiety, improve psychological readiness, and enhance patient satisfaction. Receives: Other: Standard Preprocedural Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preprocedural Anxiety
Preprocedural anxiety will be assessed using the State Anxiety Inventory (STAI-I). The STAI-I consists of 20 items scored on a 4-point Likert scale. Total scores range from 20 to 80, with higher scores indicating higher levels of state anxiety.
Measured: Immediately before upper gastrointestinal endoscopy
Secondary outcomes (2)
Psychological Readiness
Psychological readiness will be assessed using a single-item question asking participants how psychologically prepared they feel for the endoscopy procedure. Responses are scored from 1 (not at all prepared) to 5 (very well prepared), with higher scores indicating greater psychological readiness.
Measured: Immediately before upper gastrointestinal endoscopy
Postprocedural Satisfaction
Postprocedural satisfaction will be assessed using a single-item satisfaction question scored from 1 (not satisfied at all) to 5 (very satisfied). Higher scores indicate greater patient satisfaction with the endoscopy procedure.
Measured: Immediately after upper gastrointestinal endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start30 Aug 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the virtual reality intervention group or the standard care control group using block randomization.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ardahan University
- Sponsor type
- University, hospital or other
- Collaborators
- Gümüşhane Universıty
- Responsible party
- Principal investigator, Derya Şimşekli, Ardahan University
- Investigators
- DERYA ŞİMŞEKLİ, Dr., Principal investigator, Ardahan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745959
- Sponsor's protocol ID
- ArdahanU-Simsekli-DS-07
- Status last verified
- Jul 2026
- First submitted
- 30 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- 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 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Before Upper Gastrointestinal Endoscopy on Preprocedural Anxiety, Psychological Readiness, and Postprocedural Satisfaction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07745959
- Acronym / sponsor ID
- ArdahanU-Simsekli-DS-07
- Conditions
- Upper Gastrointestinal Disorders
- Keywords
- Virtual Reality, Upper Gastrointestinal Endoscopy, Preprocedural Anxiety, Psychological Readiness, Patient Satisfaction, State Anxiety, Endoscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Ardahan UniversityUniversity, hospital or other
- Collaborators
- Gümüşhane Universıty
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 4 Aug 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.
Objective: This study aims to evaluate the effect of virtual reality applied before upper gastrointestinal endoscopy on preprocedural anxiety, psychological readiness, and postprocedural satisfaction.
Methods: This randomized controlled trial will be conducted in the Endoscopy Unit of Kelkit State Hospital. A total of 64 patients scheduled to undergo upper gastrointestinal endoscopy will be enrolled and randomly assigned in a 1:1 ratio to either the virtual reality intervention group or the control group. Participants in the intervention group will receive a virtual reality application before the endoscopy procedure, whereas participants in the control group will receive standard care. Data will be collected using the Endoscopy Patient Information Form, the State Anxiety Inventory (STAI-I), a single-item Psychological Readiness Assessment, and a single-item Postprocedural Satisfaction Assessment. Anxiety and psychological readiness will be evaluated before the procedure, and patient satisfaction will be assessed immediately after the procedure.
Expected Results: It is anticipated that the virtual reality intervention will reduce preprocedural anxiety, improve psychological readiness, and increase postprocedural satisfaction compared with standard care.
Detailed description
Upper gastrointestinal endoscopy is one of the most frequently performed diagnostic procedures for evaluating disorders of the upper gastrointestinal tract. Although it is generally considered safe, many patients experience considerable anxiety before the procedure. High levels of preprocedural anxiety may negatively affect psychological readiness, reduce patient cooperation, impair the overall procedural experience, and decrease satisfaction with care. Therefore, effective non-pharmacological interventions that improve the patient's psychological state before endoscopy are needed.
Virtual reality (VR) is an immersive technology that provides visual and auditory stimulation, allowing individuals to become engaged in a relaxing virtual environment and divert their attention from stressful situations. Previous studies have demonstrated that virtual reality can reduce anxiety, pain, and physiological stress during various medical procedures. However, evidence regarding the effectiveness of virtual reality when applied before upper gastrointestinal endoscopy, particularly its effects on psychological readiness and postprocedural satisfaction, remains limited.
This randomized controlled trial aims to evaluate the effect of virtual reality applied before upper gastrointestinal endoscopy on preprocedural anxiety, psychological readiness, and postprocedural satisfaction. The study will be conducted in the Endoscopy Unit of Kelkit State Hospital. A total of 64 patients who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to either the virtual reality intervention group or the control group using block randomization.
Participants in the intervention group will receive a virtual reality application before the endoscopy procedure in addition to standard care. Participants in the control group will receive standard preprocedural care only. Data will be collected using the Endoscopy Patient Information Form, the State Anxiety Inventory (STAI-I), a single-item Psychological Readiness Assessment, and a single-item Postprocedural Satisfaction Assessment. Anxiety and psychological readiness will be evaluated before the procedure, while postprocedural satisfaction will be assessed immediately after completion of the endoscopy.
The findings of this study are expected to provide evidence regarding the effectiveness of virtual reality as a simple, non-invasive, and low-cost intervention for reducing preprocedural anxiety, improving patients' psychological readiness for upper gastrointestinal endoscopy, and enhancing satisfaction with the procedure. The results may contribute to the development of evidence-based nursing interventions and improve patient-centered care in endoscopy units.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either the virtual reality intervention group or the standard care control group using block randomization.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Virtual RealityParticipants will receive a virtual reality intervention before upper gastrointestinal endoscopy in addition to standard preprocedural care. The virtual reality application will be administered before the endoscopy procedure using a virtual reality headset. |
| Standard Care Group | Active comparator | Other: Standard Preprocedural CareParticipants will receive a virtual reality intervention using a virtual reality headset before upper gastrointestinal endoscopy. The intervention is designed to reduce preprocedural anxiety, improve psychological readiness, and enhance patient satisfaction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 years or older
- Scheduled to undergo upper gastrointestinal endoscopy
- Able to understand and communicate in Turkish
- Willing to participate in the study
- Providing written informed consent
Key exclusion criteria (5 listed)
- Presence of a diagnosed psychiatric or neurological disorder that may interfere with participation
- Presence of a visual, hearing, head, face, or eye condition that prevents the use of a virtual reality headset
- History of severe vertigo, motion sickness, or balance disorder
- Development of severe dizziness, nausea, eye strain, or discomfort during the virtual reality intervention
- Refusal to participate or withdrawal from the study
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 RealityParticipants will receive the institution's standard preprocedural care before upper gastrointestinal endoscopy without the virtual reality intervention. | Device | Experimental |
| Standard Preprocedural CareParticipants will receive the institution's routine preprocedural care before upper gastrointestinal endoscopy without virtual reality. | Other | Standard Care Group |
Primary outcome
Preprocedural Anxiety
Time frame: Immediately before upper gastrointestinal endoscopy
Preprocedural anxiety will be assessed using the State Anxiety Inventory (STAI-I). The STAI-I consists of 20 items scored on a 4-point Likert scale. Total scores range from 20 to 80, with higher scores indicating higher levels of state anxiety.
2 secondary outcomes
Psychological Readiness
Time frame: Immediately before upper gastrointestinal endoscopy
Postprocedural Satisfaction
Time frame: Immediately after upper gastrointestinal endoscopy
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 4 Aug 2026.
- 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.
DERYA ŞİMŞEKLİ, Dr. principal investigator
Ardahan 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 and Standard Preprocedural Care in people with Upper Gastrointestinal Disorders, run by Ardahan 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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 4 Aug 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?
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?
Contact DERYA ŞİMŞEKLİ, PhD (+905545965789, deryasimsekli@ardahan.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preprocedural Anxiety (time frame: Immediately before upper gastrointestinal endoscopy). 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 4 Aug 2026.