- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07484815
Virtual Reality Intervention to Reduce Pain in Women Undergoing Elective Oocyte Cryopreservation (OPU-VR)
The Effectiveness of Virtual Reality for Pain Reduction in Women Undergoing Elective Oocyte Cryopreservation: A Randomized Controlled 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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Adar Hamrani, MD
- Phone Number: +972-54-5560848
- Email: adarha@hadassah.org.il
Study Locations
-
-
-
Jerusalem, Israel
- Recruiting
- Hadassah Medical Organization
-
Contact:
- Hadas Lemberg, PhD
- Phone Number: 00 972 2 6777572
- Email: lhadas@hadassah.org.il
-
Principal Investigator:
- Anat Hershko-Klement, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality Intervention Group
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.
|
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.
|
|
Active Comparator: Control Group
Participants receive routine care prior to oocyte retrieval without exposure to virtual reality.
|
Participants receive routine care prior to oocyte retrieval without exposure to virtual reality.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post-procedure pain intensity
Time Frame: 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.
|
Immediately post-procedure in the recovery room (within 1 hour after oocyte retrieval)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Baseline pain sensitivity
Time Frame: 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.
|
Before oocyte retrieval
|
|
Heart rate during oocyte retrieval
Time Frame: 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.
|
Before, during, and after oocyte retrieval and prior to discharge on the day of the procedure
|
|
Pain intensity prior to discharge
Time Frame: 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.
|
Prior to discharge (same day as oocyte retrieval)
|
|
Change in pain intensity from pre-procedure to post-procedure
Time Frame: 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.
|
From pre-procedure (at admission) to immediately post-procedure in the recovery room
|
|
Post-procedure analgesic consumption
Time Frame: 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.
|
From completion of oocyte retrieval until discharge from the recovery unit
|
|
Systolic blood pressure during oocyte retrieval
Time Frame: 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.
|
Before, during, and after oocyte retrieval and prior to discharge on the day of the procedure
|
|
Diastolic blood pressure during oocyte retrieval
Time Frame: 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.
|
Before, during, and after oocyte retrieval and prior to discharge on the day of the procedure
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anat Hershko-Klement, MD, Hadassah Medical Center, Mount Scopus Campus, Jerusalem, Israel
- Study Director: Adar Hamrani, MD, Hadassah Medical Center, Mount Scopus Campus, Jerusalem, Israel
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0497-23-HMO-CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Pain
-
Rajavithi HospitalCompletedTotal Abdominal Hysterectomy ,Pain , Acute Postoperative,Gabapentin , CelecoxibThailand
-
Zagazig UniversityRecruiting
-
Schulthess KlinikNot yet recruiting
-
Seoul National University HospitalNot yet recruiting
-
TC Erciyes UniversityCompletedPostoperative Pain, AcuteTurkey
-
Cairo UniversityNot yet recruitingPostoperative Pain, Acute
-
Federal State Budgetary Organization, Federal Center...Completed
-
Bursa Uludag UniversitesiCompleted
-
Ain Shams UniversityRecruiting
-
Cairo UniversityRecruitingPost Operative Pain, AcuteEgypt
Clinical Trials on Virtual reality relaxation intervention
-
Istituto Auxologico ItalianoCompletedGeneralized Anxiety DisorderItaly
-
Filiz KeskinEnrolling by invitationPregnancy | Sleep Quality | Comfort | Nausea and Vomiting in Pregnancy (NVP)Turkey (Türkiye)
-
Assistance Publique Hopitaux De MarseilleCompletedGeneralized Anxiety DisordersFrance
-
King's College LondonCompletedStress, Psychological | Psychological Burnout | Mental Health BurdenUnited Kingdom
-
University of BishaCompletedVirtual Reality | Anxiety and Fear | Stress (Psychology) | Relaxation Therapy | Education Nursing | Student NursingSaudi Arabia
-
National Institute of Mental Health, Czech RepublicCharles University, Czech Republic; Motol University HospitalCompletedLife Threatening Diseases | Pediatric Palliative Care | Life Limiting ConditionsCzechia
-
University of TurkuCity of Helsinki; University of Dundee; University of St AndrewsCompleted
-
Charite University, Berlin, GermanyCompleted
-
National Institute of Mental Health, Czech RepublicEnrolling by invitationAnxiety Disorders | Relaxation | Biofeedback TrainingCzechia