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

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

Inclusion Criteria:

Female 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.

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.