Virtual Reality for Anxiety and Pain Management During Oocyte Retrieval in IVF/ICSI Treatment

NCT05555498 | Unknown

• 1 other identifier: 2010170
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

Despite current anxiety and pain management during oocyte retrieval in IVF/ICSI treatment by conscious sedation, oocyte retrieval often remains painful and stressful for patients. An average pain score of 6.0 (expressed using VAS) and stress score of 41.63 (using STAI-S) were reported by previous researches. Previous research showed there might be a negative correlation between anxiety experienced in IVF/ICSI treatment, and ongoing pregnancy rate. Other researches nuance this. In addition, conscious sedation can give a variety of side effects such as apnea and respiratory depression. The appliance of Virtual Reality is increasingly researched, in a variety of procedures. Previous researches showed that Virtual Reality was effective in the reduction of anxiety and pain experienced, also in the field of Gynaecology and Obstetrics. We hypothesized that Virtual Reality can aid in the reduction of anxiety and pain experienced during oocyte retrieval in IVF/ICSI treatment. We also aim to find a definitive answer on the question whether anxiety during IVF/ICSI treatment can negatively influence ongoing pregnancy rates.

Conditions

IVF; Procedural Pain; Procedural Anxiety

Outcome Measures

Primary Outcomes (1)

• Reduction of anxiety during oocyte retrieval

  Assessed using the STAI-S. A score between 20 and 80 can be calculated. The higher the score, the more severe the anxiety experienced is.

  2 hours

Secondary Outcomes (8)

• Reduction of pain scores during oocyte retrieval

  2 hours

• Duration of the procedure

  2 hours

• Satisfaction score of the patient

  2 hours

• satisfaction score of the care giver

  2 hours

• Occurrence of side effects

  3 days

Study Arms (2)

Intervention group: VR-glasses added to standard care of conscious sedation

EXPERIMENTAL

For the intervention group, Virtual Reality glasses will be administered on top of standard pain and anxiety management. Standard pain and management consists of conscious sedation, where benzodiazepines and opioids are administrered. In addition, participants are asked to complete 4 questionnaires on different times : immediately before, immediately after and three days after oocyte retrieval. In case of ongoing pregnancy, women are asked to complete a questionnaire approximately a month after their expected date of delivery.

Device: Virtual Reality glasses

standard care consisting of conscious sedation

NO INTERVENTION

The control group will receive standard pain- and anxiety management during oocyte retrieval in IVF/ICSI treatment, consisting of opioids combined with benzodiazepines. This will result in a conscious sedated state. In addition, participants are asked to complete 4 questionnaires on different times : immediately before, immediately after and three days after oocyte retrieval. In case of ongoing pregnancy, women are asked to complete a questionnaire approximately a month after their expected date of delivery.

Interventions

Virtual Reality glasses DEVICE

The intervention used are Virtual Reality glasses. The VR-glasses used are designed by SyncVR medical (Utrecht, the Netherlands), and are applicable specifically for medical use. By distracting the patients' cognition from the procedure, using images and sounds, the patient hopefully experiences less pain and anxiety. Women can choose between relaxation excersises and nature films

Intervention group: VR-glasses added to standard care of conscious sedation

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Between 18 and 43 years of age;
• Undergoing oocyte retrieval as part of IVF/ICSI treatment;
• Be able to understand and read the Dutch or English language.

You may not qualify if:

• Chronic use of pain medication;
• Chronic use of anti-depressants or sedatives;
• Women who previously underwent an oocyte retrieval with a VR intervention;
• Women undergoing oocyte retrieval because of fertility preservation;
• Women with visual or auditive impairment;
• Technology-related sensitivity such as motion-sickness, dizziness, epilepsy, seizures, active nausea and vomiting;
• Women who are not willing or able to give their informed consent.

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

Amsterdam UMC, location VUmc

Amsterdam, North Holland, 1081 HV, Netherlands

Location

Related Publications (1)

• van Haaps AP, Schreurs AMF, Rosielle K, Mijatovic V, Kallewaard JW, Dreyer K. No anxiety or pain reduction by Virtual Reality during oocyte retrieval in IVF/ICSI treatment: results of a randomized controlled trial. Hum Reprod. 2025 Oct 7:deaf193. doi: 10.1093/humrep/deaf193. Online ahead of print.

  PMID: 41057042 DERIVED

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Patients are randomised between the intervention group where VR glasses are added to standard care with conscious sedation (intervention group), and the control group where only standard care consisting of conscious sedation (opioids with benzodiazepines) is applied. When assigned to the intervention group, the patient will wear VR-glasses during the entire procedure of oocyte retrieval in IVF/ICSI treatment. Due to the nature of the intervention, double blind randomisation is not possible.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: September 27, 2022
• Study Start: November 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: May 1, 2025
• Last Updated: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)