Virtual Reality for Pain and Anxiety During HyFoSy
ConditionInfertility
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHaEmek Medical Center, Israel
About this trial
This randomized controlled study will evaluate whether virtual reality (VR) reduces procedural pain and anxiety in women undergoing hysterosalpingo-foam sonography (HyFoSy), a minimally invasive ultrasound-based procedure used to assess uterine anatomy and fallopian tube patency. Participants will be randomly assigned to either a VR intervention group or a standard-care control group. The primary outcome will be maximum pain experienced during the procedure, assessed using a Visual Analog Scale (VAS). Secondary outcomes will include state anxiety, heart rate variability (as a physiological measure of autonomic response to procedural stress) and patient satisfaction
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
virtual reality
BehavioralParticipants will use commercially available virtual reality goggles to view relaxing immersive content selected by the participant. The VR intervention will begin approximately 5 minutes before the HyFoSy procedure and will continue throughout the procedure
rest
Other interventionresting before the procedure- standard care
Treatment groups
68 Participants
are divided into 2 treatment groupsGroup A: Virtual RealityExperimental treatment 1 intervention
Group B: Standard CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Maximum Procedural Pain Score on the Visual Analog Scale
Maximum pain experienced by the participant during the HyFoSy procedure, assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. The maximum pain score reported during the procedure will be compared between the virtual reality and standard-care groups.
Time frame
Immediately after completion of the HyFoSy procedureSecondary outcomes
1
Change in State Anxiety Score on the STAI-S
State anxiety will be assessed using the State subscale of the Spielberger State-Trait Anxiety Inventory (STAI-S). Higher scores indicate greater state anxiety. The change in STAI-S score from immediately before the procedure to immediately after the procedure will be compared between the virtual reality and standard-care groups.
Time frame
From immediately before the HyFoSy procedure to immediately after the procedure2
Change in Current Pain Score on the Visual Analog Scale
Current pain will be assessed using a Visual Analog Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. The change in current pain score from immediately before the procedure to immediately after the procedure will be compared between study groups.
Time frame
From immediately before to immediately after the HyFoSy procedure3
Heart Rate During the HyFoSy Procedure
Heart rate will be continuously recorded using a Polar H10 chest strap. Mean heart rate during predefined pre-procedure, procedural, and post-procedure periods will be compared between study groups.
Time frame
During the 5-minute pre-procedure period, throughout the HyFoSy procedure, and during the 5-minute post-procedure period4
Heart Rate Variability: RMSSD
Heart rate variability will be assessed using the root mean square of successive differences (RMSSD), derived from continuous heart rate recordings obtained using a Polar H10 chest strap. RMSSD will be evaluated during predefined pre-procedure, procedural, and post-procedure periods and compared between study groups.
Time frame
During the 5-minute pre-procedure period, throughout the HyFoSy procedure, and during the 5-minute post-procedure periodSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: