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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
112
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
Amsterdam UMC, location VUmc
Amsterdam, North Holland, Netherlands
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.
Time frame: 2 hours
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 2 hours
Occurrence of side effects
Measured using a questionnaire, with a 5-point Likert Scale.
Time frame: 3 days
Ongoing pregnancy rate
Defined as the precence of a heart beat at 10 to 12 weeks gestation
Time frame: 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.
Time frame: 3 days
Immersiveness in the VR program
Measured using a questionnaire, with a 5-point Likert Scale.
Time frame: 2 hours
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