Clinical trial NCT05555498: Virtual Reality for Anxiety and Pain Management During Oocyte Retrieval in IVF/ICSI Treatment
Official title: Virtual Reality for Anxiety and Pain Management During Oocyte Retrieval in IVF/ICSI Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: IVF
Procedural Pain
Procedural Anxiety
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reduction of anxiety during oocyte retrieval
timeFrame: 2 hours
Secondary outcomes:
measure: Reduction of pain scores during oocyte retrieval
timeFrame: 2 hours
measure: Duration of the procedure
timeFrame: 2 hours
measure: Satisfaction score of the patient
timeFrame: 2 hours
measure: satisfaction score of the care giver
timeFrame: 2 hours
measure: Occurrence of side effects
timeFrame: 3 days
measure: Ongoing pregnancy rate
timeFrame: 10 months
measure: Use of oral analgesics
timeFrame: 3 days
measure: Immersiveness in the VR program
timeFrame: 2 hours
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, location VUmc
state: Noord Holland
Study officials:
References: