InfertilityNCT07816393
Virtual Reality for Pain and Anxiety During HyFoSy
A study testing virtual reality and rest in people with Infertility, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility
- What is being tested?
- virtual reality and rest
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Sep 2026to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site
HaEmek Medical Center
Afula
Maya MUHLBAUER AVNI, 972545993958, mayamuhlbauer@gmail.com
About this study
Official title: 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
Read the detailed description
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
- Conditions
- Infertility
- Being tested
- virtual reality, rest
- Keywords
- heart rate variability, Procedural Anxiety, Procedural Pain, Virtual Reality, HyFoSy, Hysterosalpingo-Foam Sonography
- Medical subject headings
- Infertility, Pain, Procedural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityBehavioural
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
restOther
resting before the procedure- standard care
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after completion of the HyFoSy procedure
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after completion of the HyFoSy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816393
- Sponsor's protocol ID
- 27-26-EMC
- Status last verified
- Aug 2026
- First submitted
- 7 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality as a Tool to Reduce Pain, Anxiety, and Stress in Patients Undergoing Hysterosalpingo-Foam Sonography (HyFoSy): A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07816393
- Acronym / sponsor ID
- 27-26-EMC
- Conditions
- Infertility
- Keywords
- heart rate variability, Procedural Anxiety, Procedural Pain, Virtual Reality, HyFoSy, Hysterosalpingo-Foam Sonography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Behavioral: virtual realityParticipants 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 |
| Standard Care | Active comparator | Other: restParticipants will rest for approximately 5 minutes before the HyFoSy procedure and will undergo the procedure according to standard clinical practice without virtual reality intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual realityParticipants 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 | Behavioural | Virtual Reality |
| restresting before the procedure- standard care | Other | Standard Care |
Primary outcome
Maximum Procedural Pain Score on the Visual Analog Scale
Time frame: Immediately after completion of the HyFoSy procedure
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.
8 secondary outcomes
Change in State Anxiety Score on the STAI-S
Time frame: From immediately before the HyFoSy procedure to immediately after the procedure
Change in Current Pain Score on the Visual Analog Scale
Time frame: From immediately before to immediately after the HyFoSy procedure
Heart Rate During the HyFoSy Procedure
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
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
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
Time frame: Immediately after completion of the HyFoSy procedure
Physician-Rated Procedural Difficulty
Time frame: Immediately after completion of the HyFoSy procedure
Successful Completion of the HyFoSy Procedure
Time frame: Immediately after completion of the HyFoSy procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality and rest in people with Infertility, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maya MUHLBAUER AVNI, Dr. (972545993958, mayamuhlbauer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Procedural Pain Score on the Visual Analog Scale (time frame: Immediately after completion of the HyFoSy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.