Virtual Reality for Pain and Anxiety During HyFoSy

NCT07816393 | Not Yet Recruiting

• 1 other identifier: 27-26-EMC
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Infertility

Keywords

heart rate variability; Procedural Anxiety; Procedural Pain; Virtual Reality; HyFoSy; Hysterosalpingo-Foam Sonography

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Change in State Anxiety Score on the STAI-S

  From immediately before the HyFoSy procedure to immediately after the procedure

• Change in Current Pain Score on the Visual Analog Scale

  From immediately before to immediately after the HyFoSy procedure

• Heart Rate During the HyFoSy Procedure

  During the 5-minute pre-procedure period, throughout the HyFoSy procedure, and during the 5-minute post-procedure period

• Heart Rate Variability: RMSSD

  During the 5-minute pre-procedure period, throughout the HyFoSy procedure, and during the 5-minute post-procedure period

• Heart Rate Variability: pNN50

  During the 5-minute pre-procedure period, throughout the HyFoSy procedure, and during the 5-minute post-procedure period

Study Arms (2)

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

Behavioral: virtual reality

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

Other: rest

Interventions

virtual reality BEHAVIORAL

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

Virtual Reality

rest OTHER

resting before the procedure- standard care

Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

HaEmek Medical Center

Afula, Israel

Location

MeSH Terms

Conditions

Infertility; Pain, Procedural

Interventions

RE1-silencing transcription factor

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maya MUHLBAUER AVNI, Dr.

CONTACT

972545993958; mayamuhlbauer@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2029
• Last Updated: September 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)