Women HealthNCT07545850
Determination of the Effect of Using Virtual Glasses on Pain and Anxiety During IUD Application
A study testing virtual reality application in people with Women Health, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled experimental study aimed to determine the effect of using virtual glasses during IUD application on pain and anxiety. The hypotheses of the study were determined as follows. H1-a: Using virtual glasses during IUD application affects the level of pain. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Women Health
- What is being tested?
- virtual reality application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 Mar 2024to 31 Aug 2026
- 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 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Literate,
- No communication problems,
- No psychiatric diagnosis,
Who cannot join
- diagnosed with psychiatric disorders having vision problems wearing glasses
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This randomized controlled experimental study aimed to determine the effect of using virtual glasses during IUD application on pain and anxiety.
The hypotheses of the study were determined as follows. H1-a: Using virtual glasses during IUD application affects the level of pain. H1-b: Using virtual glasses during IUD application affects the level of anxiety.
Read the detailed description
Data collection tools will be collected from women who applied IUD between March 2024-March 2025 at the Family Planning Clinic of Malatya Education and Research Hospital and who agreed to participate in the study, using the face-to-face interview method on weekdays by the researchers. Data will be collected in two stages. The application time of the data collection tools is planned to be completed in approximately 20 minutes as pre-test and post-test. Before the SG glasses are applied to the women in the experimental group, the Personal Information Form, State Anxiety Scale (SAS), and Visual Analog Scale (VAS) will be applied and pre-test data will be collected. Then, these women will watch videos with nature scenery while using SG glasses. After the IUD application process is completed, the State Anxiety Scale (SAS), Visual Analog Scale (VAS) and a survey containing questions about SG glasses will be applied to the women in the experimental group again and the post-test data will be collected and the data collection process will be completed. Pre-test data will be collected by applying the State Anxiety Scale (SAS) and Visual Analog Scale (VAS) to the women in the control group before the IUD application. No intervention will be applied to these women during the IUD application process. After the IUD application process is completed, the State Anxiety Scale (SAS) and Visual Analog Scale (VAS) will be applied to the women in the control group again, and the post-test data will be collected, and the data collection process will be completed.
- Conditions
- Women Health
- Being tested
- virtual reality application
- Keywords
- UID Aplication, virtual reality, anxiety, pain, women health
- 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 applicationOther
Virtual reality (VR) glasses are used as a midwifery intervention to reduce anxiety, stress, comfort and pain by directing the individual's attention to a different direction. VR glasses are a stress induction method that provides a fictional reality simulation with visual-visual orientation and three-dimensional views that allow the person to experience real-time perspective. Although the purpose of designing VR glasses is the entertainment sector and architectural studies, the use of VR glasses in the medical field has been increasing recently. In clinical areas, VR glasses are used to direct the attention of patients to another direction, reduce anxiety, stress and pain, and provide comfort and convenience. Some studies in the field of obstetrics reveal the positive effect of VR glasses.
| Study group | Role | What they receive |
|---|---|---|
| standard care | No intervention | The group that did not use virtual reality glasses |
| group that used virtual reality glasses | Experimental | The group that used virtual reality glasses Receives: Other: virtual reality application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
VAS is a scale created between 0-10 cm. According to the scale, 0 cm: pain is not severe at all, 10 cm: unbearable pain. On the scale, 0-44 mm indicates mild pain, 45-74 mm indicates moderate pain, and 75-100 mm indicates severe pain.
Measured: 20 minute
Secondary outcomes (1)
Spielberger State Anxiety Inventory
The State Anxiety Inventory (SAI) requires the individual to describe how he/she feels at a certain moment and under certain conditions. The inventory is answered using 4-point scales. The feelings and behaviors expressed in the SAI items are indicated by selecting one of the following options: "(1) Not at all, (2) A little, (3) A lot, and (4) Completely" according to the severity of such experiences. There are 10 reverse items in the SAI. These are items 1, 2, 5, 8, 10, 11, 15, 16, 19, and 20. The remaining items 3, 4, 6, 7, 9, 12, 13, 14, 17, and 18 directly measure the expression. Two separate keys are prepared to determine the total weights of the direct and reverse items in scoring. The total weighted score of the reverse items is subtracted from the total weighted score obtained for direct expressions. A previously determined unchanging value is added to this obtained number. This value is 50 for the State Anxiety Inventory. A high score obtained from the scale indicates a high
Measured: 20 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start31 Mar 2024
- Primary completion31 Mar 2024
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women HealthStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Crossover
- Model description
- Crossover Assignment randomized controlled trial conducted with experimental and control groups.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mevhibe Coban, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545850
- Sponsor's protocol ID
- 2023/5362
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research results will be shared
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effect of Using Virtual Glasses on Pain and Anxiety During IUD Application
- ClinicalTrials.gov ID
- NCT07545850
- Acronym / sponsor ID
- 2023/5362
- Conditions
- Women Health
- Keywords
- UID Aplication, virtual reality, anxiety, pain, women health
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 31 Mar 2024 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 22 Apr 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 experimental study aimed to determine the effect of using virtual glasses during IUD application on pain and anxiety.
The hypotheses of the study were determined as follows. H1-a: Using virtual glasses during IUD application affects the level of pain. H1-b: Using virtual glasses during IUD application affects the level of anxiety.
Detailed description
Data collection tools will be collected from women who applied IUD between March 2024-March 2025 at the Family Planning Clinic of Malatya Education and Research Hospital and who agreed to participate in the study, using the face-to-face interview method on weekdays by the researchers. Data will be collected in two stages. The application time of the data collection tools is planned to be completed in approximately 20 minutes as pre-test and post-test. Before the SG glasses are applied to the women in the experimental group, the Personal Information Form, State Anxiety Scale (SAS), and Visual Analog Scale (VAS) will be applied and pre-test data will be collected. Then, these women will watch videos with nature scenery while using SG glasses. After the IUD application process is completed, the State Anxiety Scale (SAS), Visual Analog Scale (VAS) and a survey containing questions about SG glasses will be applied to the women in the experimental group again and the post-test data will be collected and the data collection process will be completed. Pre-test data will be collected by applying the State Anxiety Scale (SAS) and Visual Analog Scale (VAS) to the women in the control group before the IUD application. No intervention will be applied to these women during the IUD application process. After the IUD application process is completed, the State Anxiety Scale (SAS) and Visual Analog Scale (VAS) will be applied to the women in the control group again, and the post-test data will be collected, and the data collection process will be completed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Crossover Assignment randomized controlled trial conducted with experimental and control groups.
| Arm | Type | Receives |
|---|---|---|
| standard care | No intervention | –The group that did not use virtual reality glasses |
| group that used virtual reality glasses | Experimental | Other: virtual reality applicationThe group that used virtual reality glasses |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Literate,
- No communication problems,
- No psychiatric diagnosis,
Key exclusion criteria (1 listed)
- diagnosed with psychiatric disorders having vision problems wearing 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 applicationVirtual reality (VR) glasses are used as a midwifery intervention to reduce anxiety, stress, comfort and pain by directing the individual's attention to a different direction. VR glasses are a stress induction method that provides a fictional reality simulation with visual-visual orientation and three-dimensional views that allow the person to experience real-time perspective. Although the purpose of designing VR glasses is the entertainment sector and architectural studies, the use of VR glasses in the medical field has been increasing recently. In clinical areas, VR glasses are used to direct the attention of patients to another direction, reduce anxiety, stress and pain, and provide comfort and convenience. Some studies in the field of obstetrics reveal the positive effect of VR glasses. | Other | group that used virtual reality glasses |
Primary outcome
Visual Analog Scale (VAS)
Time frame: 20 minute
VAS is a scale created between 0-10 cm. According to the scale, 0 cm: pain is not severe at all, 10 cm: unbearable pain. On the scale, 0-44 mm indicates mild pain, 45-74 mm indicates moderate pain, and 75-100 mm indicates severe pain.
1 secondary outcome
Spielberger State Anxiety Inventory
Time frame: 20 minute
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 22 Apr 2026.
- Noben L, Goossens SMTA, Truijens SEM, Van BMMG, Perquin CW, Slooter GD, Van RSJ. A virtual reality video to improve information provision and reduce anxiety before cesarean delivery: randomized controlled trial. JMIR mental health 2019, 6: 1-13.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Research results will be shared
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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.
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 virtual reality application in people with Women Health, run by Inonu 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 3 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 22 Apr 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?
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 (VAS) (time frame: 20 minute). 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 22 Apr 2026.