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

IVF Clinical Trial

— VitRo  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05555498
• Other study ID #: 2010170
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: May 1, 2025

Study information

• Verified date: September 2022
• Source: Amsterdam UMC, location VUmc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 112
• Est. completion date: May 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 43 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• IVF
• Pain, Procedural
• Procedural Anxiety
• Procedural Pain

Intervention

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

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, location VUmc	Amsterdam	Noord Holland

Sponsors (1)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Occurrence of side effects	Measured using a questionnaire, with a 5-point Likert Scale.	3 days
Secondary	Ongoing pregnancy rate	Defined as the precence of a heart beat at 10 to 12 weeks gestation	10 months
Secondary	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
Secondary	Immersiveness in the VR program	Measured using a questionnaire, with a 5-point Likert Scale.	2 hours