PainNCT07325695
Effect of Virtual Reality Glasses on Pain and Anxiety During Intrauterine Device Insertion in Women
A study testing Virtual Reality Headset in people with Pain and Anxiety, run by Serap Ozturk Altinayak at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the effect of virtual reality glasses on pain perception and anxiety levels during intrauterine device insertion in women. Participants undergoing intrauterine device insertion will be randomly assigned to either a virtual reality invervention group or a standard care control group. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- What is being tested?
- Virtual Reality Headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2025to 31 Jul 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Those aged 18-49
- Those who understand and speak Turkish
- Those without visual or hearing impairments
- Women who agree to participate in the study
- Those with adequate mental and emotional health
- Those who will undergo a copper intrauterine device (IUD)
Who cannot join
- Those outside the 18-49 age range
- Those who do not speak Turkish
- Those with visual, hearing, or speech impairments
- Those with diagnosed psychiatric illnesses
- Those taking psychiatric medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality Glasses on Perceived Pain and State Anxiety Levels During Intrauterine Device Insertion: a Randomized Controlled Study
This study aims to evaluate the effect of virtual reality glasses on pain perception and anxiety levels during intrauterine device insertion in women. Participants undergoing intrauterine device insertion will be randomly assigned to either a virtual reality invervention group or a standard care control group. Pain intensity and anxiety levels will be assessed during and after the procedure using validated measurement tools. The findings of this study may contribute to improving patient comfort during intrauterine device insertion.
Read the detailed description
This randomized controlled study will be conducted among women scheduled for intrauterine device insertion. Eligible participants will be randomly allocated into two groups: a virtual reality intervention group and a control group receiving standard care. Participants in the intervention group will be use virtual reality glasses during the intrauterine device insertion procedure, while the control group will undergo the procedure without virtual reality. Pain intensity will be measured using a validated pain scale during and after the procedure. Anxiety levels will be assessed using a validated state anxiety measurement tool. Sociodemographic and clinical characteristics of participants will also be recorded. The study will be conducted in accordance with ethical principles, and informed consent will be obtained from all participants.
- Being tested
- Virtual Reality Headset
- Keywords
- virtual reality, anxiety, pain management
- Medical subject headings
- Pain, Anxiety Disorders, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality HeadsetDevice
A VR headset will be used to provide immersive distraction during intrauterine device insertion to reduce pain and anxiety
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Participants will wear a VR headset during IUD insertion for pain and anxiety distraction Receives: Device: Virtual Reality Headset |
| Control Group | No intervention | Participants will receive standard care during IUD insertion without VR intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain insensity during IUD insertion
Pain severity will be measured immediately after the IUD insertion procedure using the Visual Analog Scale
Measured: İmmediately after the procedure
Pain catastrophizing(Pain Catastrophizing Scale, PCS)
Pain catastrophizing will be assessed immediatel the IUD insertion procedure using the Pain Catastrophizing Scale(PCS;13 items). Higher scores indicate greater catastrophizing.
Measured: İmmediately after the procedure
State Anxiety level(STAI-S)
State anxiety will be measured immediately after the procedure using the State-Trait Anxiety Inventory- State Subscale(STAI-S). Higher scores indicate greater anxiety.
Measured: İmmediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start4 Mar 2025
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Two parallel groups wiil be compared: VR distraction during IUD insertion versus standard care control
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serap Ozturk Altinayak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Serap Ozturk Altinayak, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325695
- Sponsor's protocol ID
- Ondokuz Mayıs Üniversitesi
- Status last verified
- Dec 2025
- First submitted
- 9 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses on Perceived Pain and State Anxiety Levels During Intrauterine Device Insertion: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07325695
- Acronym / sponsor ID
- Ondokuz Mayıs Üniversitesi
- Keywords
- virtual reality, anxiety, pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Serap Ozturk AltinayakUniversity, hospital or other
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 8 Jan 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 study aims to evaluate the effect of virtual reality glasses on pain perception and anxiety levels during intrauterine device insertion in women. Participants undergoing intrauterine device insertion will be randomly assigned to either a virtual reality invervention group or a standard care control group. Pain intensity and anxiety levels will be assessed during and after the procedure using validated measurement tools. The findings of this study may contribute to improving patient comfort during intrauterine device insertion.
Detailed description
This randomized controlled study will be conducted among women scheduled for intrauterine device insertion. Eligible participants will be randomly allocated into two groups: a virtual reality intervention group and a control group receiving standard care. Participants in the intervention group will be use virtual reality glasses during the intrauterine device insertion procedure, while the control group will undergo the procedure without virtual reality. Pain intensity will be measured using a validated pain scale during and after the procedure. Anxiety levels will be assessed using a validated state anxiety measurement tool. Sociodemographic and clinical characteristics of participants will also be recorded. The study will be conducted in accordance with ethical principles, and informed consent will be obtained from all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two parallel groups wiil be compared: VR distraction during IUD insertion versus standard care control
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Device: Virtual Reality HeadsetParticipants will wear a VR headset during IUD insertion for pain and anxiety distraction |
| Control Group | No intervention | –Participants will receive standard care during IUD insertion without VR intervention |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Those aged 18-49
- Those who understand and speak Turkish
- Those without visual or hearing impairments
- Women who agree to participate in the study
- Those with adequate mental and emotional health
Key exclusion criteria (5 listed)
- Those outside the 18-49 age range
- Those who do not speak Turkish
- Those with visual, hearing, or speech impairments
- Those with diagnosed psychiatric illnesses
- Those taking psychiatric medications
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 HeadsetA VR headset will be used to provide immersive distraction during intrauterine device insertion to reduce pain and anxiety | Device | Virtual Reality Group |
Primary outcome
Pain insensity during IUD insertion
Time frame: İmmediately after the procedure
Pain severity will be measured immediately after the IUD insertion procedure using the Visual Analog Scale
Pain catastrophizing(Pain Catastrophizing Scale, PCS)
Time frame: İmmediately after the procedure
Pain catastrophizing will be assessed immediatel the IUD insertion procedure using the Pain Catastrophizing Scale(PCS;13 items). Higher scores indicate greater catastrophizing.
State Anxiety level(STAI-S)
Time frame: İmmediately after the procedure
State anxiety will be measured immediately after the procedure using the State-Trait Anxiety Inventory- State Subscale(STAI-S). 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 8 Jan 2026.
- Individual participant dataSharing planned: No. No individual participant data 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. 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 Virtual Reality Headset in people with Pain and Anxiety, run by Serap Ozturk Altinayak 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 6 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 8 Jan 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?
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?
Pain insensity during IUD insertion (time frame: İmmediately after the procedure). The study lists 3 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 8 Jan 2026.