Acute Pain, Procedure-Related Pain
Conditions
Keywords
Virtual Reality, Oocyte Retrieval, Pain Management, Fertility Preservation, Non-Pharmacological Intervention, Reproductive Medicine, Patient Comfort, Elective Oocyte Cryopreservation
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALVirtual reality relaxation intervention
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.
BEHAVIORALStandard Care Control
Participants receive routine care prior to oocyte retrieval without exposure to virtual reality.
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Due to the nature of the intervention, masking of participants and care providers is not feasible.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Women undergoing elective oocyte retrieval for fertility preservation. * Age 18-45 years. * Ability to provide informed consent.
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: * History of seizures * Sensitivity to flashing light or motion * Migraine headaches * Predisposition to nausea or dizziness (e.g., vertigo) * Any injury to the eyes, face, or neck limiting use of the VR device, including blindness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-procedure pain intensity | Immediately post-procedure in the recovery room (within 1 hour after oocyte retrieval) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Baseline pain sensitivity | Before oocyte retrieval | 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. |
| Heart rate during oocyte retrieval | Before, during, and after oocyte retrieval and prior to discharge on the day of the procedure | eart rate (beats per minute) measured at predefined time points before, during, and after oocyte retrieval as an indicator of physiological stress. |
| Pain intensity prior to discharge | Prior to discharge (same day as oocyte retrieval) | 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. |
| Change in pain intensity from pre-procedure to post-procedure | From pre-procedure (at admission) to immediately post-procedure in the recovery room | 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. |
| Post-procedure analgesic consumption | From completion of oocyte retrieval until discharge from the recovery unit | Use of analgesic medications during the post-procedure recovery period, documented from medical records, including type and dosage of administered analgesics. |
| Systolic blood pressure during oocyte retrieval | Before, during, and after oocyte retrieval and prior to discharge on the day of the procedure | Systolic blood pressure (mmHg) measured at predefined time points before, during, and after oocyte retrieval as an indicator of physiological stress. |
| Diastolic blood pressure during oocyte retrieval | Before, during, and after oocyte retrieval and prior to discharge on the day of the procedure | Diastolic blood pressure (mmHg) measured at predefined time points before, during, and after oocyte retrieval as an indicator of physiological stress. |
Countries
Israel
Contacts
CONTACTAdar Hamrani, MD
PRINCIPAL_INVESTIGATORAnat Hershko-Klement, MD
Hadassah Medical Center, Mount Scopus Campus, Jerusalem, Israel
STUDY_DIRECTORAdar Hamrani, MD
Hadassah Medical Center, Mount Scopus Campus, Jerusalem, Israel
Outcome results
None listed