AnxietyVR-GYNNCT07059780
Effect of Virtual Reality on Anxiety and Pain During Gynecological Examination
A study testing Virtual Reality Glasses in people with Anxiety and Pain, run by Fazilet Nur Daşkın at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to examine the effects of using virtual reality (VR) glasses during gynecological examinations on women's pain and anxiety levels. A total of 126 women were randomly assigned to either an intervention group, who used VR glasses during the examination, or a control group, who… Read more about this study
- Who is it for?
- Ages 19 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Pain, Gynecological Examination
- 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
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 30 Mar 2025
- 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 19 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women aged between 19 and 49 years
- Literate and able to complete the questionnaire
- Agree to participate voluntarily
- Undergoing gynecological examination
Who cannot join
- Having a diagnosed gynecological cancer
- Hearing or visual impairments
- Cognitive or communication difficulties
- History of psychiatric illness
- Refusal to wear VR glasses
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erciyes University Gevher Nesibe Hospital
Kayseri, Melikgazi
About this study
Official title: A Randomized Controlled Trial Investigating the Effect of Virtual Reality Glasses on Anxiety and Pain Levels in Women During Gynecological Examination
This randomized controlled trial aims to examine the effects of using virtual reality (VR) glasses during gynecological examinations on women's pain and anxiety levels. A total of 126 women were randomly assigned to either an intervention group, who used VR glasses during the examination, or a control group, who received standard care. Visual and auditory stimuli from nature-themed videos were shown to the intervention group using VR glasses during the procedure. Participants' pain was assessed using the Visual Analog Scale (VAS), and anxiety was measured using the State-Trait Anxiety Inventory (STAI-I). The study was conducted between February and November 2024 at the Department of Obstetrics and Gynecology, Erciyes University Hospital.
Read the detailed description
This study was designed to investigate the effect of virtual reality (VR) glasses on pain and anxiety levels experienced by women during gynecological examinations. It was conducted as a randomized controlled experimental study between February and November 2024 at Erciyes University Gevher Nesibe Hospital, Department of Obstetrics and Gynecology.
A total of 126 participants were randomly assigned to intervention and control groups (63 each). Inclusion criteria included women aged between 19 and 49 years, literate, and voluntarily agreeing to participate. Women with gynecological cancer, communication impairments, or visual/auditory disabilities were excluded.
The intervention group received standard gynecological examination procedures along with VR glasses showing immersive nature videos during the examination. The control group underwent the examination without VR intervention. Data collection tools included a Personal Information Form, Pain Beliefs Questionnaire, the Visual Analog Scale (VAS) for pain, and the State-Trait Anxiety Inventory-I (STAI-I) for anxiety. In addition, a Satisfaction Form was applied to the intervention group after the examination.
The aim of the study was to determine whether VR application can reduce perceived pain and anxiety during gynecological procedures. The findings of this study are expected to contribute to non-pharmacological nursing interventions in women's health practices.
- Conditions
- Anxiety, Pain, Gynecological Examination, Women's Health
- Being tested
- Virtual Reality Glasses
- Keywords
- anxiety, pain, virtual reality, Women's Health, gynecological examination
- 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 GlassesDevice
Participants in the intervention group wore virtual reality (VR) glasses during the gynecological examination. The VR content included immersive nature-themed scenes accompanied by calming background music. The intervention aimed to provide a multisensory distraction to reduce perceived anxiety and pain levels during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Intervention Group | Experimental | Participants in this group underwent a routine gynecological examination while wearing virtual reality glasses that displayed immersive nature-themed videos with visual and auditory stimuli to reduce anxiety and pain. Receives: Device: Virtual Reality Glasses |
| Routine Care Without VR Group | No intervention | Participants in this group received standard gynecological examination without any virtual reality intervention. No visual or auditory stimulus was provided during the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State Anxiety Score (STAI-I)
The State Anxiety Inventory (STAI-I) consists of 20 self-report items that measure how the individual feels at a specific moment. Each item is rated on a 4-point Likert scale: 1 (Not at all) to 4 (Very much so). The scale includes both direct and reverse-scored items. Reverse-scored items include items 1, 2, 5, 8, 10, 11, 16, 19, and 20. The total score is calculated by subtracting the sum of reverse-scored items from the sum of direct items and then adding 50. Total scores range from 20 to 80, with higher scores indicating greater anxiety. The questionnaire will be administered immediately before and 15 minutes after the gynecological examination. The change in scores will be analyzed to evaluate the intervention's effectiveness.
Measured: Baseline (immediately before the examination) and Post-procedure (within 15 minutes after the examination)
Visual Analog Scale for Pain (VAS)
The Visual Analog Scale for Pain (VAS) is a widely used unidimensional tool designed to assess subjective pain intensity. It consists of a 10-centimeter horizontal line anchored by two descriptors: "no pain" on the left end and "worst imaginable pain" on the right. Participants will be asked to place a mark along the line that best reflects the intensity of their current pain. The distance (in centimeters) from the left end to the mark will be measured, yielding a score between 0 and 10, with higher scores indicating greater pain intensity. The VAS will be administered once, within 10 minutes following the gynecological examination.
Measured: Post-procedure (within 10 minutes after the gynecological examination)
Secondary outcomes (1)
Pain Beliefs Questionnaire - PBQ)
The Pain Beliefs Questionnaire (PBQ) will be administered immediately before the gynecological examination to evaluate participants' beliefs about pain.
The PBQ contains 12 items divided into two subscales:
Organic Beliefs Subscale (8 items): Items 1, 2, 3, 5, 7, 8, 10, 11
Psychological Beliefs Subscale (4 items): Items 4, 6, 9, 12
Each item is rated using a 6-point Likert scale (1 = always, 2 = almost always, 3 = often, 4 = sometimes, 5 = rarely, 6 = never).
Scores for each subscale will be calculated by averaging the responses of the corresponding items. There is no cutoff point. Higher scores reflect stronger beliefs related to the respective dimension.
The total score range for each subscale is 1 to 6. Higher scores indicate stronger organic or psychological beliefs about pain.
Measured: Baseline (within 30 minutes before the gynecological examination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 Feb 2024
- Primary completion30 Nov 2024
- Study completion30 Mar 2025
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.
- 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
- Participants were randomly assigned to two groups: the intervention group received virtual reality during the procedure, and the control group received standard care.
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fazilet Nur Daşkın
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fazilet Nur Daşkın, TC Erciyes University
- Investigators
- Evrim Bayraktar, PhD, Study chair, Erciyes University Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059780
- Sponsor's protocol ID
- ERU-SBE-FND-2025
- Other IDs
- 2023/728
- Acronym
- VR-GYN
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to privacy considerations and ethical restrictions imposed by the institutional review board.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Investigating the Effect of Virtual Reality Glasses on Anxiety and Pain Levels in Women During Gynecological Examination
- ClinicalTrials.gov ID
- NCT07059780
- Acronym / sponsor ID
- VR-GYN / ERU-SBE-FND-2025
- Conditions
- Anxiety, Pain, Gynecological Examination, Women's Health
- Keywords
- anxiety, pain, virtual reality, Women's Health, gynecological examination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Fazilet Nur DaşkınUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 11 Jul 2025 (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 aims to examine the effects of using virtual reality (VR) glasses during gynecological examinations on women's pain and anxiety levels. A total of 126 women were randomly assigned to either an intervention group, who used VR glasses during the examination, or a control group, who received standard care. Visual and auditory stimuli from nature-themed videos were shown to the intervention group using VR glasses during the procedure. Participants' pain was assessed using the Visual Analog Scale (VAS), and anxiety was measured using the State-Trait Anxiety Inventory (STAI-I). The study was conducted between February and November 2024 at the Department of Obstetrics and Gynecology, Erciyes University Hospital.
Detailed description
This study was designed to investigate the effect of virtual reality (VR) glasses on pain and anxiety levels experienced by women during gynecological examinations. It was conducted as a randomized controlled experimental study between February and November 2024 at Erciyes University Gevher Nesibe Hospital, Department of Obstetrics and Gynecology.
A total of 126 participants were randomly assigned to intervention and control groups (63 each). Inclusion criteria included women aged between 19 and 49 years, literate, and voluntarily agreeing to participate. Women with gynecological cancer, communication impairments, or visual/auditory disabilities were excluded.
The intervention group received standard gynecological examination procedures along with VR glasses showing immersive nature videos during the examination. The control group underwent the examination without VR intervention. Data collection tools included a Personal Information Form, Pain Beliefs Questionnaire, the Visual Analog Scale (VAS) for pain, and the State-Trait Anxiety Inventory-I (STAI-I) for anxiety. In addition, a Satisfaction Form was applied to the intervention group after the examination.
The aim of the study was to determine whether VR application can reduce perceived pain and anxiety during gynecological procedures. The findings of this study are expected to contribute to non-pharmacological nursing interventions in women's health practices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to two groups: the intervention group received virtual reality during the procedure, and the control group received standard care.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Intervention Group | Experimental | Device: Virtual Reality GlassesParticipants in this group underwent a routine gynecological examination while wearing virtual reality glasses that displayed immersive nature-themed videos with visual and auditory stimuli to reduce anxiety and pain. |
| Routine Care Without VR Group | No intervention | –Participants in this group received standard gynecological examination without any virtual reality intervention. No visual or auditory stimulus was provided during the procedure. |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women aged between 19 and 49 years
- Literate and able to complete the questionnaire
- Agree to participate voluntarily
- Undergoing gynecological examination
Key exclusion criteria (5 listed)
- Having a diagnosed gynecological cancer
- Hearing or visual impairments
- Cognitive or communication difficulties
- History of psychiatric illness
- Refusal to wear VR glasses
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 GlassesParticipants in the intervention group wore virtual reality (VR) glasses during the gynecological examination. The VR content included immersive nature-themed scenes accompanied by calming background music. The intervention aimed to provide a multisensory distraction to reduce perceived anxiety and pain levels during the procedure. | Device | Virtual Reality Intervention Group |
Primary outcome
Change in State Anxiety Score (STAI-I)
Time frame: Baseline (immediately before the examination) and Post-procedure (within 15 minutes after the examination)
The State Anxiety Inventory (STAI-I) consists of 20 self-report items that measure how the individual feels at a specific moment. Each item is rated on a 4-point Likert scale: 1 (Not at all) to 4 (Very much so). The scale includes both direct and reverse-scored items. Reverse-scored items include items 1, 2, 5, 8, 10, 11, 16, 19, and 20. The total score is calculated by subtracting the sum of reverse-scored items from the sum of direct items and then adding 50. Total scores range from 20 to 80, with higher scores indicating greater anxiety. The questionnaire will be administered immediately before and 15 minutes after the gynecological examination. The change in scores will be analyzed to evaluate the intervention's effectiveness.
Visual Analog Scale for Pain (VAS)
Time frame: Post-procedure (within 10 minutes after the gynecological examination)
The Visual Analog Scale for Pain (VAS) is a widely used unidimensional tool designed to assess subjective pain intensity. It consists of a 10-centimeter horizontal line anchored by two descriptors: "no pain" on the left end and "worst imaginable pain" on the right. Participants will be asked to place a mark along the line that best reflects the intensity of their current pain. The distance (in centimeters) from the left end to the mark will be measured, yielding a score between 0 and 10, with higher scores indicating greater pain intensity. The VAS will be administered once, within 10 minutes following the gynecological examination.
1 secondary outcome
Pain Beliefs Questionnaire - PBQ)
Time frame: Baseline (within 30 minutes before the gynecological examination)
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 11 Jul 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to privacy considerations and ethical restrictions imposed by the institutional review board.
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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.
Evrim Bayraktar, PhD study chair
Erciyes University Faculty of Health Sciences
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 Anxiety and Pain, run by Fazilet Nur Daşkın 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 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: finished, as of the sponsor's last update on 11 Jul 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?
Change in State Anxiety Score (STAI-I) (time frame: Baseline (immediately before the examination) and Post-procedure (within 15 minutes after the examination)). The study lists 2 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 11 Jul 2025.