Early Pregnancy LossNCT07907679
Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss
A study testing Virtual reality distraction in people with Early Pregnancy Loss and Procedural Pain, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial summary
This study will examine whether virtual reality can reduce pain and anxiety in women undergoing surgical uterine evacuation after early pregnancy loss at Tarsus State Hospital, Türkiye. Ninety women will be randomly assigned to two groups of 45 participants each. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early Pregnancy Loss, Procedural Pain, Anxiety
- What is being tested?
- Virtual reality distraction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2026to 30 Apr 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 years or older.
- Ultrasound-confirmed diagnosis of early pregnancy loss (missed miscarriage, anembryonic pregnancy, or incomplete miscarriage).
- Scheduled for surgical uterine evacuation.
- Gestational age below 12 weeks.
- Able to read and understand Turkish and communicate with the research team.
- Provides written informed consent.
Who cannot join
- Hemodynamic instability.
- Septic miscarriage.
- Heavy vaginal bleeding requiring emergency surgery.
- Severe visual or hearing impairment.
- History of epilepsy or a neurological disorder that may prevent the use of virtual reality.
- History of severe motion sickness.
- Currently receiving treatment for a psychiatric disorder.
- Planned general anesthesia during the procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gamze Çelik, BSc contact
Turkey (Türkiye)1 site
Tarsus State Hospital
Tarsus, Mersin, 33460
Gamze Çelik, Bsc, +90 (324) 613 47 00, 254131010@tarsus.edu.tr
About this study
Official title: The Effect of Virtual Reality on Pain and Anxiety During Surgical Uterine Evacuation in Women Experiencing Early Pregnancy Loss: A Randomized Controlled Trial
This study will examine whether virtual reality can reduce pain and anxiety in women undergoing surgical uterine evacuation after early pregnancy loss at Tarsus State Hospital, Türkiye. Ninety women will be randomly assigned to two groups of 45 participants each. One group will receive virtual reality in addition to routine care, while the other group will receive routine care alone. Researchers will compare pain, anxiety, and vital signs between the groups to assess the effects of virtual reality.
- Conditions
- Early Pregnancy Loss, Procedural Pain, Anxiety
- Being tested
- Virtual reality distraction
- Keywords
- Virtual Reality, Surgical Uterine Evacuation, Miscarriage, Midwifery
- Medical subject headings
- Abortion, Spontaneous, Pain, Procedural, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality distractionDevice
Participants will view standardized relaxing nature scenes with nature sounds through a virtual reality headset, in addition to routine care. The intervention will begin immediately before speculum insertion and continue until surgical uterine evacuation is completed. Audio volume will allow communication with the clinical team. The intervention will be stopped if the participant requests removal or experiences discomfort. Duration, completion status, and reasons for discontinuation will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality plus routine care | Experimental | Participants will receive virtual reality through a headset during surgical uterine evacuation, in addition to routine clinical care. Receives: Device: Virtual reality distraction |
| Routine care | No intervention | Participants will receive routine clinical care during surgical uterine evacuation without virtual reality. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak procedural pain assessed by the Visual Analog Scale (VAS)
Peak procedural pain will be assessed retrospectively once, within 10-15 minutes after surgical uterine evacuation, when the participant's clinical condition permits. Before the procedure, participants in both groups will receive identical instructions explaining that they will be asked afterward to recall their highest pain during the procedure and mark it on a 10-cm Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (unbearable pain). Higher scores indicate greater pain. No pain questions or scales will be administered during the procedure. Both groups will be assessed using the same method and time window. Existing pre-procedure pain will be measured separately at baseline using the same scale and distinguished from procedural pain. The timing and method of pain assessment are explained in the informed consent forms.
Measured: Once within 10-15 minutes after completion of surgical uterine evacuation, when the participant's clinical condition permits.
Secondary outcomes (6)
State anxiety assessed by the State-Trait Anxiety Inventory-State Scale (STAI-I)
State anxiety will be assessed using the Turkish version of the 20-item State-Trait Anxiety Inventory-State Scale (STAI-I). Total scores range from 20 to 80, with higher scores indicating greater state anxiety. Scores will be compared between groups and between pre-procedure and post-procedure assessments.
Measured: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.
Systolic blood pressure
Systolic blood pressure will be measured in mmHg before and after the procedure and compared between groups and assessment times.
Measured: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.
Diastolic blood pressure
Diastolic blood pressure will be measured in mmHg before and after the procedure and compared between groups and assessment times.
Measured: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.
Pulse rate
Pulse rate will be measured in beats per minute before and after the procedure and compared between groups and assessment times.
Measured: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.
Respiratory rate
Respiratory rate will be measured in breaths per minute before and after the procedure and compared between groups and assessment times.
Measured: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.
Peripheral oxygen saturation (SpO2)
Peripheral oxygen saturation will be measured as a percentage before and after the procedure and compared between groups and assessment times.
Measured: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study startNov 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Pregnancy LossStudies 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 will be randomly assigned in a 1:1 ratio to virtual reality plus routine care or routine care alone.
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe ŞENOĞLU, Tarsus University
- Investigators
- Ayşe ŞENOĞLU, PhD, Principal investigator, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907679
- Sponsor's protocol ID
- Tarsus-Gamze-VR-2026
- Status last verified
- Oct 2026
- First submitted
- 25 Oct 2026
- Last updated
- 3 Nov 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality on Pain and Anxiety During Surgical Uterine Evacuation in Women Experiencing Early Pregnancy Loss: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07907679
- Acronym / sponsor ID
- Tarsus-Gamze-VR-2026
- Conditions
- Early Pregnancy Loss, Procedural Pain, Anxiety
- Keywords
- Virtual Reality, Surgical Uterine Evacuation, Miscarriage, Midwifery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 30 Oct 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 will examine whether virtual reality can reduce pain and anxiety in women undergoing surgical uterine evacuation after early pregnancy loss at Tarsus State Hospital, Türkiye. Ninety women will be randomly assigned to two groups of 45 participants each. One group will receive virtual reality in addition to routine care, while the other group will receive routine care alone. Researchers will compare pain, anxiety, and vital signs between the groups to assess the effects of virtual reality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to virtual reality plus routine care or routine care alone.
| Arm | Type | Receives |
|---|---|---|
| Virtual reality plus routine care | Experimental | Device: Virtual reality distractionParticipants will receive virtual reality through a headset during surgical uterine evacuation, in addition to routine clinical care. |
| Routine care | No intervention | –Participants will receive routine clinical care during surgical uterine evacuation without virtual reality. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 years or older.
- Ultrasound-confirmed diagnosis of early pregnancy loss (missed miscarriage, anembryonic pregnancy, or incomplete miscarriage).
- Scheduled for surgical uterine evacuation.
- Gestational age below 12 weeks.
- Able to read and understand Turkish and communicate with the research team.
Key exclusion criteria (8 listed)
- Hemodynamic instability.
- Septic miscarriage.
- Heavy vaginal bleeding requiring emergency surgery.
- Severe visual or hearing impairment.
- History of epilepsy or a neurological disorder that may prevent the use of virtual reality.
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 distractionParticipants will view standardized relaxing nature scenes with nature sounds through a virtual reality headset, in addition to routine care. The intervention will begin immediately before speculum insertion and continue until surgical uterine evacuation is completed. Audio volume will allow communication with the clinical team. The intervention will be stopped if the participant requests removal or experiences discomfort. Duration, completion status, and reasons for discontinuation will be recorded. | Device | Virtual reality plus routine care |
Primary outcome
Peak procedural pain assessed by the Visual Analog Scale (VAS)
Time frame: Once within 10-15 minutes after completion of surgical uterine evacuation, when the participant's clinical condition permits.
Peak procedural pain will be assessed retrospectively once, within 10-15 minutes after surgical uterine evacuation, when the participant's clinical condition permits. Before the procedure, participants in both groups will receive identical instructions explaining that they will be asked afterward to recall their highest pain during the procedure and mark it on a 10-cm Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (unbearable pain). Higher scores indicate greater pain. No pain questions or scales will be administered during the procedure. Both groups will be assessed using the same method and time window. Existing pre-procedure pain will be measured separately at baseline using the same scale and distinguished from procedural pain. The timing and method of pain assessment are explained in the informed consent forms.
6 secondary outcomes
State anxiety assessed by the State-Trait Anxiety Inventory-State Scale (STAI-I)
Time frame: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.
Systolic blood pressure
Time frame: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.
Diastolic blood pressure
Time frame: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.
Pulse rate
Time frame: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.
Respiratory rate
Time frame: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.
Peripheral oxygen saturation (SpO2)
Time frame: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.
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 3 Nov 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.
Gamze Çelik, BSc contact
Ayşe ŞENOĞLU, PhD principal investigator
Tarsus 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 distraction in people with Early Pregnancy Loss and Procedural Pain, run by Tarsus 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 6 inclusion and 8 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 3 Nov 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 Ayşe ŞENOĞLU, PhD (90 (324) 600 00 33 ext. 2226, aysesenoglu@tarsus.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak procedural pain assessed by the Visual Analog Scale (VAS) (time frame: Once within 10-15 minutes after completion of surgical uterine evacuation, when the participant's clinical condition permits.). 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 3 Nov 2026.