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
Hysterosalpingo-foam sonography (HyFoSy) is a minimally invasive ultrasound-based procedure used to evaluate the uterine cavity and fallopian tube patency as part of the infertility evaluation. Although HyFoSy is generally well tolerated and is associated with less pain than hysterosalpingography, some women experience procedural pain and anxiety. Pain and anxiety associated with gynecological procedures may negatively affect the patient experience and may contribute to avoidance of future gynecological examinations and procedures. Anxiety may also contribute to cervical spasm and potentially increase the technical difficulty of the procedure. Virtual reality (VR) is a non-pharmacological intervention that has been investigated for reducing pain, anxiety, and stress during various medical procedures. Previous studies in obstetrics and gynecology have reported beneficial effects of VR during procedures including amniocentesis, hysteroscopy, and intrauterine insemination. However, the effect of VR during HyFoSy has not been adequately studied. The purpose of this randomized controlled study is to evaluate the effect of VR on procedural pain and anxiety during HyFoSy compared with standard care. The primary outcome will be maximum procedural pain assessed using a Visual Analog Scale (VAS). State anxiety will be assessed using the State subscale of the Spielberger State-Trait Anxiety Inventory (STAI-S). Physiological response to procedural stress will be assessed using continuous heart rate and heart rate variability (HRV) monitoring. Participants randomized to the VR intervention group will use VR goggles beginning approximately 5 minutes before the HyFoSy procedure and throughout the procedure. Participants will be able to select their preferred relaxing VR content. Participants randomized to the standard-care group will rest for approximately 5 minutes before the procedure and will undergo HyFoSy according to standard clinical practice without VR. Heart rate will be continuously monitored in both groups using a Polar H10 chest strap. HRV parameters, including the root mean square of successive differences (RMSSD) and the percentage of successive normal sinus RR intervals differing by more than 50 milliseconds (pNN50), will be evaluated as physiological measures of autonomic response to procedural stress. The study will additionally evaluate patient satisfaction, physician-rated procedural difficulty, and successful completion of the HyFoSy examination
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
68
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
resting before the procedure- standard care
HaEmek Medical Center
Afula, Israel
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 procedure
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 procedure
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 procedure
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 period
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 period
Heart Rate Variability: pNN50
The percentage of successive normal sinus RR intervals differing by more than 50 milliseconds (pNN50) will be calculated from continuous heart rate recordings obtained using a Polar H10 chest strap. Values 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 period
Patient-Reported Satisfaction With the HyFoSy Procedure
Participants will report their experience during the HyFoSy procedure using study-specific questions addressing perceived comfort and satisfaction. Participants in the virtual reality group will additionally report whether they perceived VR as helpful or disruptive, whether they perceived a reduction in pain or anxiety, whether they would recommend VR to another woman undergoing HyFoSy, and whether they would choose VR for a future gynecological procedure.
Time frame: Immediately after completion of the HyFoSy procedure
Physician-Rated Procedural Difficulty
The physician performing the HyFoSy procedure will rate the procedural difficulty as easy, moderately difficult, or difficult.
Time frame: Immediately after completion of the HyFoSy procedure
Successful Completion of the HyFoSy Procedure
The HyFoSy examination will be classified as successfully completed, non-diagnostic, or unable to be completed.
Time frame: Immediately after completion of the HyFoSy procedure
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