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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: IVF; Procedural Pain; Procedural Anxiety
• Intervention / Treatment: Device: Virtual Reality glasses

Detailed Description

Patients undergoing oocyte retrieval as part of IVF/ICSI treatment are often still anxious and experience pain despite adequate management of both by applying conscious sedation, consisting of opioids combined with benzodiazepines. An average pain score of 6.0 during oocyte retrieval is reported by patients, expressed using the Visual Analogue Score (VAS). Very limited research has been done on anxiety experienced during oocyte retrieval by patients. However, in 2013 Turner et al. reported an average anxiety score of 41.63, objectified using the State-Trait Anxiety Inventory (STAI-S) of Spielberger et al. They also saw a higher pregnancy rate in women reporting a lower anxiety score (34.93 in pregnant women versus 44.35 in non-pregnant women, p=0.05). This finding was nuanced by other researches, they found no correlation between anxiety and IVF/ICSI outcomes.

There is an increased risk of side effects when benzodiazepines are added to opioids to induce conscious sedation. Due to the anxiolytic, sedative and amnesic effect of benzodiazepines, a reduction in anxiety experienced by patients is seen. Benzodiazepines combined with opioids additionally cause a depression of the central nervous system, resulting in a conscious sedative state. The patient is still fully conscious and able to communicate with the healthcare provider. However, the risk of respiratory side effects such as respiratory depression and apnea increases when conscious sedation is applied. No successful alternative to benzodiazepines has yet been found.

Virtual Reality is increasingly used successfully to reduce both anxiety and pain experienced by patients during a variety of procedures. Additionally, higher satisfaction scores by both the patient and care giver are reported when Virtual Reality was applied. By deriving the patient's cognition from the procedural pain using a Virtual Reality environment, subjective pain experienced by the patient is reduced. VR is increasingly used in the medical field, including in the field of Gynecology and Obstetrics. However, no studies have yet been conducted on the effectiveness of VR during oocyte retrieval.

Based on previous studies, where reduced pain and anxiety was seen when Virtual Reality was applied, we hypothesized that a VR intervention can aid in the reduction of pain and anxiety experienced by patients during oocyte retrieval. In addition, we hypothesize there is a higher ongoing pregnancy rate in women experiencing less anxiety during oocyte retrieval.

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord Holland
    • Amsterdam, Noord Holland, Netherlands, 1081 HV
      • Amsterdam UMC, location VUMc
      • Contact: Annelotte A.P. van Haaps, Drs; Phone Number: 020 0204445277; Email: a.vanhaaps@amsterdamumc.nl
      • Contact: Velja V Mijatovic, Prof. Dr.; Phone Number: 0204445277; Email: mijatovic@amsterdamumc.nl
      • Sub-Investigator: Annelotte van Haaps, Drs
      • Principal Investigator: Velja Mijatovic, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group: VR-glasses added to standard care of conscious sedation; 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; 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
No Intervention: standard care consisting of conscious sedation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of pain scores during oocyte retrieval	Measured using a VAS-score, scale 0-10. The higher the VAS-score, the more pain the participant exprienced.	2 hours
Duration of the procedure	When the patients' anxiety is reduced, it is expected that she is more relaxed and the procedure will run more smoothly resulting in a shorter duration of the procedure.	2 hours
Satisfaction score of the patient	Measured using the Numeric Rating Scale, with a scale from 0 to 10. The higher the NRS-score, the higher patient satisfaction.	2 hours
satisfaction score of the care giver	Measured using the Numeric Rating Scale, with a scale from 0 to 10. The higher the NRS-score, the higher care giver satisfaction.	2 hours
Occurrence of side effects	Measured using a questionnaire, with a 5-point Likert Scale.	3 days
Ongoing pregnancy rate	Defined as the precence of a heart beat at 10 to 12 weeks gestation	10 months
Use of oral analgesics	Possible need for pain medication until 3 days after oocyte retrieval. Measured using a questionnaire that is send 3 days after oocyte retrieval.	3 days
Immersiveness in the VR program	Measured using a questionnaire, with a 5-point Likert Scale.	2 hours

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 27, 2022

Study Record Updates

• Last Update Posted (Actual): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pain; Neurologic Manifestations; Anxiety Disorders; Pain, Procedural
• Other Study ID Numbers: 2010170

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No trial data will be shared with other researchers. Only the researchers involved in the trial will be able to see the data. All participants will be assigned an anonymous code. To this code, all study data will be collected. The key to the codes will be stored at the research center, in a sealed digital map.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No