Virtual Reality Intervention to Reduce Pain in Women Undergoing Elective Oocyte Cryopreservation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorHadassah Medical Organization
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Women undergoing elective oocyte retrieval for fertility preservation.
Age 18-45 years.
Ability to provide informed consent.
Disqualifiers
Use of pain relief, anti-anxiety, or antidepressant medications prior to the intervention.
History of seizures
Sensitivity to flashing light or motion
Migraine headaches
Trial design
Design model
Parallel
Treatments tested in this trial
Virtual reality relaxation intervention
BehavioralParticipants 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.
Standard Care Control
BehavioralParticipants receive routine care prior to oocyte retrieval without exposure to virtual reality.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Virtual Reality Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Immediately post-procedure in the recovery room (within 1 hour after oocyte retrieval)Secondary outcomes
1
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.
Time frame
Before oocyte retrieval2
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.
Time frame
Before, during, and after oocyte retrieval and prior to discharge on the day of the procedure3
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.
Time frame
Prior to discharge (same day as oocyte retrieval)4
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.
Time frame
From pre-procedure (at admission) to immediately post-procedure in the recovery roomSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov