Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This randomized controlled study evaluates whether exposure to relaxing virtual reality (VR) scenery prior to oocyte retrieval can reduce pain in women undergoing elective oocyte cryopreservation.
Many women experience discomfort before and after oocyte retrieval. Virtual reality has been shown to reduce pain in various medical settings by providing distraction and relaxation.
In this study, participants are randomly assigned to receive either routine care alone or routine care combined with a VR-based relaxation intervention while waiting for the procedure.
Pain is assessed using validated questionnaires and standardized scales before and after oocyte retrieval.
The results of this study may help determine whether VR can serve as a simple, safe, and non-pharmacological method to improve patient comfort during elective egg freezing.
This study is a prospective, randomized controlled clinical trial evaluating the effectiveness of virtual reality (VR) in reducing pain among women undergoing elective oocyte cryopreservation.
Eligible participants awaiting oocyte retrieval are recruited at the fertility unit. All participants receive detailed information about the study and provide written informed consent prior to enrollment.
Participants are randomized into two parallel groups. The intervention group receives routine care in addition to exposure to relaxing virtual reality nature scenery using a VR headset for approximately 20 minutes prior to oocyte retrieval. The control group receives routine care without exposure to virtual reality.
Baseline assessments include demographic data, medical history, pain sensitivity questionnaire (PSQ), baseline visual analog scale (VAS) pain score, pain threshold assessment, and vital signs.
Following the procedure, pain is reassessed using the visual analog scale. Analgesic administration is documented from medical records. Additional post-procedure assessments include pain-related parameters and vital signs.
The primary outcome is post-procedure pain intensity measured using the VAS. Secondary outcomes include pain sensitivity measures, analgesic consumption, and physiological parameters.
All collected data include demographic variables, clinical parameters, baseline and post-procedure pain scores, pain-related measures, vital signs, and medication use. Data are coded and stored in a secure institutional database.
Statistical analysis compares outcomes between groups using appropriate parametric or non-parametric methods according to data distribution.
This study aims to assess whether pre-procedure virtual reality exposure can serve as a safe and effective non-pharmacological adjunct for pain reduction in women undergoing elective oocyte cryopreservation.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality Intervention Group | Experimental | Participants receive routine care and are exposed to a relaxing virtual reality nature video using a VR headset for approximately 20 minutes prior to oocyte retrieval. |
|
| Control Group | Active Comparator | Participants receive routine care prior to oocyte retrieval without exposure to virtual reality. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality relaxation intervention | Behavioral | Participants are exposed to relaxing virtual reality nature scenery videos using a VR headset for approximately 20 minutes prior to oocyte retrieval, in addition to routine care. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-procedure pain intensity | Pain intensity measured using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain is assessed in the recovery room following oocyte retrieval. | Immediately post-procedure in the recovery room (within 1 hour after oocyte retrieval) |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline pain sensitivity | Baseline pain sensitivity measured using the Pain Sensitivity Questionnaire (PSQ), a validated self-report instrument assessing perceived pain intensity in imagined daily-life situations. Scores range from 0 to 10, with higher scores indicating greater pain sensitivity. | Before oocyte retrieval |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Use of pain relief, anti-anxiety, or antidepressant medications prior to the intervention.
Any condition for which VR use is not recommended, including:
Any injury to the eyes, face, or neck limiting use of the VR device, including blindness.
Only individuals with female biological sex undergoing oocyte retrieval are eligible to participate in this study.
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adar Hamrani, MD | Contact | +972-54-5560848 | adarha@hadassah.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Anat Hershko-Klement, MD | Hadassah Medical Center, Mount Scopus Campus, Jerusalem, Israel | Principal Investigator |
| Adar Hamrani, MD | Hadassah Medical Center, Mount Scopus Campus, Jerusalem, Israel | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Organization | Recruiting | Jerusalem | Israel |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Participants are randomized into two parallel groups: an intervention group receiving virtual reality exposure prior to oocyte retrieval and a control group receiving standard care.
Not provided
Not provided
Due to the nature of the intervention, masking of participants and care providers is not feasible.
Not provided
| Standard Care Control | Behavioral | Participants receive routine care prior to oocyte retrieval without exposure to virtual reality. |
|
| Heart rate during oocyte retrieval |
eart rate (beats per minute) measured at predefined time points before, during, and after oocyte retrieval as an indicator of physiological stress. |
| Before, during, and after oocyte retrieval and prior to discharge on the day of the procedure |
| Pain intensity prior to discharge | Pain intensity measured using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain is assessed prior to discharge on the day of oocyte retrieval. | Prior to discharge (same day as oocyte retrieval) |
| Change in pain intensity from pre-procedure to post-procedure | Change in pain intensity measured using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Change is calculated as post-procedure VAS score minus pre-procedure VAS score. | From pre-procedure (at admission) to immediately post-procedure in the recovery room |
| Post-procedure analgesic consumption | Use of analgesic medications during the post-procedure recovery period, documented from medical records, including type and dosage of administered analgesics. | From completion of oocyte retrieval until discharge from the recovery unit |
| Systolic blood pressure during oocyte retrieval | Systolic blood pressure (mmHg) measured at predefined time points before, during, and after oocyte retrieval as an indicator of physiological stress. | Before, during, and after oocyte retrieval and prior to discharge on the day of the procedure |
| Diastolic blood pressure during oocyte retrieval | Diastolic blood pressure (mmHg) measured at predefined time points before, during, and after oocyte retrieval as an indicator of physiological stress. | Before, during, and after oocyte retrieval and prior to discharge on the day of the procedure |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |