Pain Relief Using VR in Oocyte Retreival

May 7, 2024 updated by: Professor Ernest Hung-Yu Ng, The University of Hong Kong

A Randomized Study on Use of Virtual Reality Technology for Pain Relief in Transvaginal Oocyte Retrieval Under Conscious Sedation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction Transvaginal ultrasound guided oocyte retrieval is an essential process in in-vitro fertilization. The procedure lasts for around 10-15 minutes and is considered as a painful procedure. Different modalities of pain relief methods are used including paracervical blocks(1-3), conscious sedation (4, 5), spinal anaesthesia and general anaesthesia (6). Conscious sedation with anaesthesia was the commonly chosen method in assisted reproduction technology centers; as it enhances a faster post-procedure recovery and less anaesthetic risks as compared with general anaesthesia.

Recently, the use of immersive virtual reality technology has been applied in pain control in different medical fields especially in paediatrics, oncology and burn patients (7, 8). It provides a distraction from the acute pain during procedures and its effectiveness has been shown in meta-analysis (9, 10). In gynaecology, use of VR can significantly reduce the pain in ambulatory hysteroscopy (score 6.0 versus 3.7, p = 0.0009) (11). Another group of investigators also initiated a study on VR as pain relief in hysterosalpingogram (12). While, there is no study evaluating the use of VR in transvaginal oocyte retrieval.

In view of that, the aim of this study is to evaluate the effectiveness of VR in pain relief during transvaginal oocyte retrieval under conscious sedation.

Trial objectives and hypothesis:

The objective is to evaluate the effectiveness of VR in pain relief during transvaginal oocyte retrieval using conscious sedation.

Hypothesis VR can reduce the pain experienced during transvaginal oocyte retrieval using conscious sedation.

Trial design This is a randomized study on additional use of VR during transvaginal oocyte retrieval using conscious sedation. All subjects will receive the standard conscious sedation with 25mg IV pethidine and 5mg IV diazepam; and paracervical local anaesthetic 10ml 1% lignocaine. In addition, they will be randomized to receive immersive VR or not.

Treatment of subjects:

Women undergoing in-vitro fertilization at Department of Obstetrics and Gynaecology of Queen Mary Hospital will be assessed for eligibility. Eligible women will be recruited for the study and informed written consent will be obtained after written and oral information.

Eligible women recruited will be randomly assigned on the day of oocyte retrieval according to a computer-generated randomization list into one of the following two groups.

  1. VR group - The women will receive Immersive VR.
  2. Placebo group - They will have the VR headset put on but blank screen. Blinding of the subjects is not possible due to the nature of the intervention.

Ovarian stimulation and oocyte retrieval will be performed according to departmental Standard Operating Procedures. The VR headset will be put on prior to oocyte retrieval and it will be turned on in the VR group only. The headset will be cleansed with wipes after each use. Disposable hygiene masks will be used below the headset.

25mg Pethidine and 5mg Diazepam will be given intravenously. The blood pressure and pulse of the women are checked after the drug administration and the oxygen saturation is monitored continuously throughout the procedure. 10ml 1% lignocaine is injected to the paracervical region by the operating surgeon with a 21-gauge needle after cleansing of the vagina and cervix with chlorhexidine. Under transvaginal ultrasound guidance, a 16-gauge ovum aspiration needle is introduced. Aspiration of follicles without flushing is performed with a suction pressure of 100mmHg.

Assessment of anxiety Shortly after hospital admission in the morning, women will complete the state-trait anxiety inventory (STAI) questionnaire before oocyte retrieval to assess their trait and state anxiety.

Assessment of pain levels and sedation levels The women will be asked to rate according to a 100mm linear visual analogue scale prior to start of procedure, within 5 minutes after the procedure and four hours after the procedure prior to discharge from hospital.

They will be asked to rate:

  • The anticipated pain during the procedure
  • The worst pain during the procedure

The surgeon will score the sedation level of the women according to the scale described by Ramsay et al., at the end of the operation. Level 1: Patient anxious and agitated or restless or both; Level 2: Patient co-operative, orientated, and tranquil; Level 3: Patient responsive to commands only; Level 4: Asleep and a brisk response to loud auditory stimulus; Level 5: Asleep and a sluggish response to loud auditory stimulus; Level 6: Asleep and no response to loud auditory stimulus.

Any adverse effects experienced such as (nausea, vomiting, dizziness, drowsiness will be recorded.

They will be asked to complete the client satisfaction questionnaire before discharge.

Basic demographic data will be collected including age, indication of infertility, number of oocytes obtained, and duration of procedure.

No extra follow-up visits will be arranged solely for the study unless considered necessary by the investigators.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China
        • Department of Obstetrics and Gynaecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • - women aged > 18 years and <43 years

    • understand Chinese
    • undergoing transvaginal oocyte retrieval on both sides

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VR group
The participants will have the the virtual reality headset with immersive virtual reality.
Device: Virtual reality
immersive virtual reality technology
Placebo Comparator: Placeob group
The participants will have the virtual reality headset put on but blank screen.
Device: No virtual reality
Virtual reality with blank screen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain levels
Time Frame: Day 0
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
level of unpleasantness
Time Frame: Day 0
level of unpleasantness during oocyte retrieval (nil, mild, moderate and severe)
Day 0
client satisfaction questionnaire score
Time Frame: Day 0
scoring of client satisfaction questionnaire from 10 (minimum) to 40 (maximum); higher scores mean higher satisfaction
Day 0
Ongoing pregnancy rate
Time Frame: 10 weeks
Pregnancy rate at 8-10 weeks
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Study Director: Ernest HY Ng, MD, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Actual)

October 1, 2023

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

December 18, 2021

First Submitted That Met QC Criteria

January 19, 2022

First Posted (Actual)

February 1, 2022

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUGOR-VR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

No similar studies in this area

IPD Sharing Time Frame

Data will become available upon publication of the study and be available for 10 years.

IPD Sharing Access Criteria

any reasonable request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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