Pain Relief Using VR in Oocyte Retreival

NCT05218382 | Completed

• 1 other identifier: TUGOR-VR
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertility; Pain

Keywords

VR; IVF; oocyte retrieval; pain levels

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• level of unpleasantness

  Day 0

• client satisfaction questionnaire score

  Day 0

• Ongoing pregnancy rate

  10 weeks

Study Arms (2)

VR group

EXPERIMENTAL

The participants will have the the virtual reality headset with immersive virtual reality.

Device: Virtual reality

Placeob group

PLACEBO COMPARATOR

The participants will have the virtual reality headset put on but blank screen.

Device: No virtual reality

Interventions

Virtual reality DEVICE

immersive virtual reality technology

VR group

No virtual reality DEVICE

Virtual reality with blank screen

Placeob group

Eligibility Criteria

• Age: 18 Years - 42 Years
• Gender Eligibility Details: Infertile women undergoing oocyte retrieval
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- women aged \> 18 years and \<43 years
• understand Chinese
• undergoing transvaginal oocyte retrieval on both sides

You may not qualify if:

• Had known allergy to pethidine, diazepam or local anaesthetics
• Had oocyte retrieval performed on one ovary only
• History of claustrophobia/ susceptible to motion sickness

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Department of Obstetrics and Gynaecology

Hong Kong, Hong Kong, China

Location

Related Publications (13)

• 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.

  PMID: 12645862 RESULT

• 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.

  PMID: 11006189 RESULT

• 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.

  PMID: 10548622 RESULT

• 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.

  PMID: 29761478 RESULT

• 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.

  PMID: 32299734 RESULT

• 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.

  PMID: 31517299 RESULT

• 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.

  PMID: 28211829 RESULT

• 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.

  PMID: 29485536 RESULT

• 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.

  PMID: 31308733 RESULT

• 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.

  PMID: 32423641 RESULT

• 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.

  PMID: 32575151 RESULT

• 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.

  PMID: 31959220 RESULT

• 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.

  PMID: 40974211 DERIVED

MeSH Terms

Conditions

Infertility; Pain

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ernest HY Ng, MD

  The University of Hong Kong

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding of the participants is not possible due to the nature of the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Randomized controlled superiority trial

Study Record Dates

• First Submitted: December 18, 2021
• First Posted: February 1, 2022
• Study Start: December 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: February 1, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available upon publication of the study and be available for 10 years.
• Access Criteria: any reasonable request

Locations

CN (1)