[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655686":3},{"organization":4,"outcomesModule":7,"designInfo":42,"detailedDescription":49,"studyPopulation":41,"armGroups":50,"interventions":63,"overallOfficials":41,"centralContacts":73,"locations":79,"responsibleParty":94,"collaborators":41,"id":96,"slug":97,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":41,"eligibilityCriteria":102,"healthyVolunteers":98,"sex":103,"minAge":104,"maxAge":41,"enrollmentInfo":105,"targetDuration":41,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":120,"whyStopped":41,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"HaEmek Medical Center, Israel","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":41},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Immediately after completion of the HyFoSy procedure",[14,18,22,26,29,32,35,38],{"measure":15,"description":16,"timeFrame":17},"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.","From immediately before the HyFoSy procedure to immediately after the procedure",{"measure":19,"description":20,"timeFrame":21},"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.","From immediately before to immediately after the HyFoSy procedure",{"measure":23,"description":24,"timeFrame":25},"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.","During the 5-minute pre-procedure period, throughout the HyFoSy procedure, and during the 5-minute post-procedure period",{"measure":27,"description":28,"timeFrame":25},"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.",{"measure":30,"description":31,"timeFrame":25},"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.",{"measure":33,"description":34,"timeFrame":12},"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.",{"measure":36,"description":37,"timeFrame":12},"Physician-Rated Procedural Difficulty","The physician performing the HyFoSy procedure will rate the procedural difficulty as easy, moderately difficult, or difficult.",{"measure":39,"description":40,"timeFrame":12},"Successful Completion of the HyFoSy Procedure","The HyFoSy examination will be classified as successfully completed, non-diagnostic, or unable to be completed.",null,{"allocation":43,"interventionModel":44,"interventionModelDescription":45,"primaryPurpose":46,"observationalModel":41,"timePerspective":41,"maskingInfo":47},"RANDOMIZED","PARALLEL","Participants will be randomly assigned in a 1:1 ratio to either a virtual reality intervention group or a standard-care control group. Participants in the intervention group will use VR goggles beginning approximately 5 minutes before HyFoSy and throughout the procedure. Participants in the control group will rest for approximately 5 minutes before the procedure and will undergo HyFoSy according to standard clinical practice without VR.","SUPPORTIVE_CARE",{"masking":48,"maskingDescription":41,"whoMasked":41},"NONE","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.\n\nPain 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.\n\nVirtual 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.\n\nThe 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.\n\nParticipants 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.\n\nHeart 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.\n\nThe study will additionally evaluate patient satisfaction, physician-rated procedural difficulty, and successful completion of the HyFoSy examination",[51,57],{"label":52,"type":53,"description":54,"interventionNames":55},"Virtual Reality","EXPERIMENTAL","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",[56],"Behavioral: virtual reality",{"label":58,"type":59,"description":60,"interventionNames":61},"Standard Care","ACTIVE_COMPARATOR","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",[62],"Other: rest",[64,69],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":41},"BEHAVIORAL","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",[52],{"type":6,"name":70,"description":71,"armGroupLabels":72,"otherNames":41},"rest","resting before the procedure- standard care",[58],[74],{"name":75,"role":76,"phone":77,"phoneExt":41,"email":78},"Maya MUHLBAUER AVNI, Dr.","CONTACT","972545993958","mayamuhlbauer@gmail.com",[80],{"facility":81,"status":41,"city":82,"state":41,"zip":41,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"HaEmek Medical Center","Afula","Israel","IL",{"type":86,"coordinates":87},"Point",[88,89],35.2892,32.60907,{"lat":89,"lon":88},[92],{"name":93,"role":76,"phone":77,"phoneExt":41,"email":78},"Maya MUHLBAUER AVNI",{"type":95,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100655686","virtual-reality-for-pain-and-anxiety-during-hyfosy-100655686",false,"NCT07816393","Virtual Reality for Pain and Anxiety During HyFoSy","Virtual Reality as a Tool to Reduce Pain, Anxiety, and Stress in Patients Undergoing Hysterosalpingo-Foam Sonography (HyFoSy): A Prospective Randomized Controlled Study","Inclusion Criteria:\n\nFemale participants aged 18 years or older. Undergoing HyFoSy as part of routine clinical care. Able to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\nVisual 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.","FEMALE","18 Years",{"count":106,"type":107},68,"ESTIMATED","INTERVENTIONAL",[110],"NA","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",[113],"Infertility",[115,116,117,52,118,119],"heart rate variability","Procedural Anxiety","Procedural Pain","HyFoSy","Hysterosalpingo-Foam Sonography","NOT_YET_RECRUITING","2026-09-07",{"date":123,"type":124},"2026-09-11","ACTUAL",{"date":126,"type":107},"2026-09-15",{"date":128,"type":107},"2029-08-31",{"name":5,"class":6},1]