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Not yet recruitingNCT07907679Updated Nov 3, 2026

Virtual Reality for Pain and Anxiety During Surgical Uterine Evacuation After Early Pregnancy Loss

An interventional study of Virtual reality distraction in Early Pregnancy Loss, Procedural Pain and Anxiety, sponsored by Tarsus University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Tarsus University · Not applicable, Interventional, and Supportive care

Updated Nov 3, 2026Primary outcomes revisedNewly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Early Pregnancy Loss
  • Procedural Pain
  • Anxiety

Keywords

  • Virtual Reality
  • Surgical Uterine Evacuation
  • Miscarriage
  • Midwifery
03

In context

Abortion, Spontaneous

326 studies on the registry are indexed under Abortion, Spontaneous; 55 are open to participants now.

This study's planned enrollment of 90 is below the median of 147 across 178 interventional studies indexed under Abortion, Spontaneous.

Browse Abortion, Spontaneous studies →

Lead sponsor

Tarsus University is the lead sponsor of 82 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Virtual reality plus routine care

    Participants will receive virtual reality through a headset during surgical uterine evacuation, in addition to routine clinical care.

    Device: Virtual reality distraction

  • No intervention
    Routine care

    Participants will receive routine clinical care during surgical uterine evacuation without virtual reality.

Interventions

  • DeviceVirtual reality distraction

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Once within 10-15 minutes after completion of surgical uterine evacuation, when the participant's clinical condition permits.

Secondary outcomes

  1. 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.

    Time frame: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.

  2. Systolic blood pressure

    Systolic blood pressure will be measured in mmHg before and after the procedure and compared between groups and assessment times.

    Time frame: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.

  3. Diastolic blood pressure

    Diastolic blood pressure will be measured in mmHg before and after the procedure and compared between groups and assessment times.

    Time frame: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.

  4. Pulse rate

    Pulse rate will be measured in beats per minute before and after the procedure and compared between groups and assessment times.

    Time frame: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.

  5. Respiratory rate

    Respiratory rate will be measured in breaths per minute before and after the procedure and compared between groups and assessment times.

    Time frame: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.

  6. 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.

    Time frame: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.

07

Study locations

1 site
  • Tarsus State Hospital
    Tarsus, Mersin 33460, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • EditedPeak Procedural Pain Assessedprocedural 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.
Nov 3, 2026
Secondary outcomes
6 edited
What changed in the outcomes
  • EditedState Anxiety Assessedanxiety 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.
  • EditedSystolic Blood Pressureblood pressureTime frame: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.
  • EditedDiastolic Blood Pressureblood pressureTime frame: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.
  • EditedPulse RaterateTime frame: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.
  • EditedRespiratory RaterateTime frame: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.
  • EditedPeripheral Oxygen Saturationoxygen saturation (SpO2)Time frame: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.
Nov 3, 2026
Registered
First appeared on the registry
Oct 30, 2026
Show all 2 updates
  1. Nov 3, 2026
    Primary outcomes 1 edited
    What changed in the outcomes
    • EditedPeak Procedural Pain Assessedprocedural 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.
    Secondary outcomes 6 edited
    What changed in the outcomes
    • EditedState Anxiety Assessedanxiety 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.
    • EditedSystolic Blood Pressureblood pressureTime frame: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.
    • EditedDiastolic Blood Pressureblood pressureTime frame: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.
    • EditedPulse RaterateTime frame: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.
    • EditedRespiratory RaterateTime frame: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.
    • EditedPeripheral Oxygen Saturationoxygen saturation (SpO2)Time frame: Before the intervention and procedure, and within the first 10-15 minutes after completion of surgical uterine evacuation.
    + 2 other changes: conditions and arm descriptions
  2. Oct 30, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07907679
Lead sponsor
Tarsus University
Responsible party
Ayşe ŞENOĞLU (Assistant Professor, Tarsus University) — Principal investigator
First posted
Oct 30, 2026
Start date
Nov 2026 (estimated)
Primary completion
Apr 30, 2027 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Nov 3, 2026

Study contacts

Ayşe ŞENOĞLU, PhD
Contact
aysesenoglu@tarsus.edu.tr
90 (324) 600 00 33 ext. 2226
Gamze Çelik, BSc
Contact
254131010@tarsus.edu.tr
Ayşe ŞENOĞLU, PhD
principal investigator · Tarsus University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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