Virtual Reality for Pain and Anxiety During HyFoSy

Condition(s) studied

Investigational drug(s) / intervention(s)

virtual reality: Participants 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: resting before the procedure- standard care

Study summary

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

Primary outcome measure(s)

• Maximum Procedural Pain Score on the Visual Analog Scale — Immediately after completion of the HyFoSy procedure
  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.

Trial sites (1)

More HaEmek Medical Center, Israel trials in Israel

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