An interventional study of virtual reality and rest in Infertility, sponsored by HaEmek Medical Center, Israel. Not yet recruiting at 1 site in Israel. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by HaEmek Medical Center, Israel · Not applicable, Interventional, and Supportive care
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
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's planned enrollment of 68 is below the median of 135 across 1,412 interventional studies indexed under Infertility.
Browse Infertility studies →HaEmek Medical Center, Israel is the lead sponsor of 237 studies on the registry; 11 are open to participants now.
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Female participants aged 18 years or older. Undergoing HyFoSy as part of routine clinical care. Able to understand the study procedures and provide written .
Exclusion Criteria:
Visual impairment preventing use of the VR device. Hearing impairment preventing use of the VR content. History of motion sickness. History of epilepsy. History of schizophrenia Use of analgesic or anxiolytic medication before the procedure, outside of regular ongoing treatment.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will use virtual reality goggles beginning approximately 5 minutes before the HyFoSy procedure and continuously throughout the procedure. Participants will be able to select their preferred relaxing VR content. Standard clinical care for HyFoSy will otherwise be provided
Behavioral: virtual reality
Participants will rest for approximately 5 minutes before the HyFoSy procedure and will undergo the procedure according to standard clinical practice without virtual reality intervention
Other: rest
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
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
Plan to share: No
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