NCT05218382

Pain Relief Using VR in Oocyte Retreival

Completed NA Last updated 8 May 2024

What this trial tests

NA trial testing Virtual reality in Infertility in 160 participants. Completed in 1 February 2024.

Timeline

1 December 2022

Primary endpoint
1 October 2023

1 February 2024

Quick facts

Lead sponsor	The University of Hong Kong
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	160
Start date	1 December 2022
Primary completion	1 October 2023
Estimated completion	1 February 2024
Sites	1 location across China

Drugs / interventions tested

• Virtual reality
• No virtual reality

Conditions studied

• Infertility — all drugs for Infertility →
• Pain — all drugs for Pain →

Sponsor

The University of Hong Kong

Who can join

Adults 18 to 42, female only, with Infertility or Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Ng CSM, Tong PYW, Wong E, Cheng HHY, et al · · 2025 · cited 1× · PMID 40974211 · DOI 10.1093/humrep/deaf188