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A Randomized Study on Use of Virtual Reality Technology for Pain Relief in Transvaginal Oocyte Retrieval Under Conscious Sedation
Sponsor study identifier
interventional
160
1 country
1
Study Start
December 1, 2022
Actual (reported)Primary Completion
October 1, 2023
Actual (reported)Study Completion
February 1, 2024
Actual (reported)Title: A randomized study on use of virtual reality technology for pain relief in transvaginal oocyte retrieval under conscious sedation Objectives: The study is to evaluate the effectiveness of virtual reality (VR) in pain relief during transvaginal ultrasound-guided oocyte retrieval (TUGOR) under conscious sedation Hypothesis to be tested: VR can reduce the pain level during TUGOR. Design and subjects: This is a randomized study on additional use of VR during TUGOR. A total of 160 women undergoing oocyte retrieval on both ovaries will be recruited and randomized to one of the following groups: active and placebo groups. Those with known allergy to pethidine, diazepam or local anaesthetics; and history of claustrophobia/ susceptible to motion sickness will be excluded. Instruments: Immersive VR Interventions: All received women will receive the standard conscious sedation with 25mg IV pethidine and 5mg IV diazepam; and paracervical block of 10ml 1% lignocaine. VR headset will be put on for every woman. It will only be switched on for the active VR group but not the placebo VR group. Main outcome measures: The primary outcome measure is the maximal abdominal pain levels during TUGOR measured by a 100mm linear visual analogue scale prior. Secondary outcome measures include the pain of vaginal puncture and the abdominal pain four hours after the procedure prior to discharge from hospital. Data analysis and expected results: Data will be analysed on intention to treat basis and per protocol. Demographic features of the study groups will be compared. Chi-square test or Fisher's exact test will be used for categorical variables. Mann-Whitney U test will be used to compare the continuous variables between groups. P values of \<0.05 will be considered statistically significant.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 1, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 18, 2021
Actual (reported)February 1, 2022
Actual (reported)December 1, 2022
Actual (reported)October 1, 2023
Actual (reported)February 1, 2024
Actual (reported)Pain levels
maximal pain level during oocyte retrieval experienced by the participants measured by visual analog scale from 0-100 (maximum); higher levels mean mean painful
Day 0
level of unpleasantness
Day 0
client satisfaction questionnaire score
Day 0
Ongoing pregnancy rate
10 weeks
The participants will have the the virtual reality headset with immersive virtual reality.
The participants will have the virtual reality headset put on but blank screen.
immersive virtual reality technology
Virtual reality with blank screen
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Department of Obstetrics and Gynaecology
Hong Kong, Hong Kong, China
Ng EH, Miao B, Ho PC. A randomized double-blind study to compare the effectiveness of three different doses of lignocaine used in paracervical block during oocyte retrieval. J Assist Reprod Genet. 2003 Jan;20(1):8-12. doi: 10.1023/a:1021202604049.
Ng EH, Tang OS, Chui DK, Ho PC. Comparison of two different doses of lignocaine used in paracervical block during oocyte collection in an IVF programme. Hum Reprod. 2000 Oct;15(10):2148-51. doi: 10.1093/humrep/15.10.2148.
Ernest HY Ng, MD
The University of Hong Kong
160 participants (actual enrollment reported by the registry).
First Submitted
December 18, 2021
First Posted
February 1, 2022
Study Start
Contact the study team to confirm eligibility.
Ng EH, Tang OS, Chui DK, Ho PC. A prospective, randomized, double-blind and placebo-controlled study to assess the efficacy of paracervical block in the pain relief during egg collection in IVF. Hum Reprod. 1999 Nov;14(11):2783-7. doi: 10.1093/humrep/14.11.2783.
Kwan I, Wang R, Pearce E, Bhattacharya S. Pain relief for women undergoing oocyte retrieval for assisted reproduction. Cochrane Database Syst Rev. 2018 May 15;5(5):CD004829. doi: 10.1002/14651858.CD004829.pub4.
Lai SF, Lam MT, Li HWR, Ng EHY. A randomized double-blinded non-inferiority trial comparing fentanyl and midazolam with pethidine and diazepam for pain relief during oocyte retrieval. Reprod Biomed Online. 2020 May;40(5):653-660. doi: 10.1016/j.rbmo.2020.01.021. Epub 2020 Jan 31.
Roest I, Buisman ETIA, van der Steeg JW, Koks CAM. Different methods of pain relief for IVF and ICSI oocyte retrieval - A Dutch survey. Eur J Obstet Gynecol Reprod Biol X. 2019 Jun 15;4:100065. doi: 10.1016/j.eurox.2019.100065. eCollection 2019 Oct.
Dunn J, Yeo E, Moghaddampour P, Chau B, Humbert S. Virtual and augmented reality in the treatment of phantom limb pain: A literature review. NeuroRehabilitation. 2017;40(4):595-601. doi: 10.3233/NRE-171447.
Indovina P, Barone D, Gallo L, Chirico A, De Pietro G, Giordano A. Virtual Reality as a Distraction Intervention to Relieve Pain and Distress During Medical Procedures: A Comprehensive Literature Review. Clin J Pain. 2018 Sep;34(9):858-877. doi: 10.1097/AJP.0000000000000599.
Mallari B, Spaeth EK, Goh H, Boyd BS. Virtual reality as an analgesic for acute and chronic pain in adults: a systematic review and meta-analysis. J Pain Res. 2019 Jul 3;12:2053-2085. doi: 10.2147/JPR.S200498. eCollection 2019.
Ahmad M, Bani Mohammad E, Anshasi HA. Virtual Reality Technology for Pain and Anxiety Management among Patients with Cancer: A Systematic Review. Pain Manag Nurs. 2020 Dec;21(6):601-607. doi: 10.1016/j.pmn.2020.04.002. Epub 2020 May 15.
Deo N, Khan KS, Mak J, Allotey J, Gonzalez Carreras FJ, Fusari G, Benn J. Virtual reality for acute pain in outpatient hysteroscopy: a randomised controlled trial. BJOG. 2021 Jan;128(1):87-95. doi: 10.1111/1471-0528.16377. Epub 2020 Jul 22.
Wang YL, Gao HX, Wang JS, Wang JH, Bo L, Zhang TT, Dai YL, Gao LL, Liu Q, Zhang JJ, Cai JM, Yu JQ, Li YX. Immersive virtual reality as analgesia for women during hysterosalpingography: study protocol for a randomized controlled trial. Trials. 2020 Jan 20;21(1):102. doi: 10.1186/s13063-019-4023-y.
Ng CSM, Tong PYW, Wong E, Cheng HHY, Ko JKY, Li RHW, Ng EHY. Randomized controlled study on the use of virtual reality for pain relief in oocyte retrieval under transvaginal ultrasound guidance using paracervical block and conscious sedation. Hum Reprod. 2025 Dec 1;40(12):2310-2317. doi: 10.1093/humrep/deaf188.
December 1, 2022
Primary Completion
October 1, 2023
Actual (reported)Study Completion
February 1, 2024
Actual (reported)Last Updated
May 8, 2024
Record last verified: 2024-05
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