Clinical trial NCT04213781: Interest of Audiovisual Distraction in the Management of Anxiety and Pain During Oocyte Retrieval
Official title: Does Audiovisual Distraction Decrease the Use of Hypnotic Drugs During Oocyte Retrieval?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertilization in Vitro
Keywords: Oocyte retrieval
Sedation
Lead sponsor: CMC Ambroise Paré
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Oocyte retrieval procedure for in vitro fertilization is a source of anxiety for patients. Local anaesthesia or sedation are commonly used to manage many situations of anxiety, including the oocyte retrieval. However, this sedation should be as mild as possible in order to preserve oocytes.

HappyMed Video Glasses are a recent medical device that allows the immersion of patients in films, cartoons or concerts. By distracting patients, this technology can reduce anxiety, discomfort and ultimately pain associated with care.

This randomized monocentric trial compares audiovisual distraction versus usual care for the management of anxiety and pain related to oocyte retrieval.

Hypothesis of this study is that the audiovisual distraction carried out with the HappyMed Video Glasses reduces the use of sedative drugs during oocyte retrieval while ensuring a better comfort and a faster walking ability.

Detailed description: Consent female patients between 18 and 43 years old scheduled for oocyte retrieval will be enrolled in this study and their anxiety level will be collected via a questionnaire.

After randomization, patients will either benefit from audiovisual distraction using HappyMed Video Glasses, (medical device with CE marking), or from the usual management during procedure. The anaesthesiologist will check that no anxiolytic or sedative drug was given 12 hours before anaesthesia. The patients will be stratified according to whether or not a previous intervention was performed. Anaesthesia will be started and maintained with administration of sufentanil (0.1 μg/kg) and propofol (using the Dixon's up-and-down method). The aim is a patient who spontaneously ventilates and does not react to gynaecological stimulation. Prevention of postoperative pain and nausea/vomiting will be carried out at the initiation of the surgical procedure. The effect of these drugs is longer than the intervention duration and will not influence the protocol.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing oocyte retrieval requiring a sedation associating sufentanil and propofol
* Contactable by phone the day after the procedure.
* Consent for participation
* Affiliation to the social security system

Exclusion Criteria:

* Corneal or conjunctival diseases in progress,
* Claustrophobia
* Patients under protection of the adults (guardianship, curators or safeguard of justice)
* Communication difficulties or neuropsychiatric disorder

Primary outcomes:
measure: Target concentration of propofol administered during oocyte retrieval procedure to maintain the patient comfortable
timeFrame: Intraoperative period : from the start of anaesthesia to the end of the intervention
Secondary outcomes:
measure: Side effects due to audiovisual distraction
timeFrame: 4 hours
measure: Patient comfort during propofol injection
timeFrame: 30 minutes
measure: Complications due to anaesthesia
timeFrame: up to 24 hours (from the start of anaesthesia to the patient's discharge of the recovery room)
measure: Resumption of walking
timeFrame: 12 hours
measure: Health staff satisfaction
timeFrame: 2 hours
measure: Patient satisfaction
timeFrame: 4 hours
measure: Resuming activities of daily living
timeFrame: 24 hours
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital FOCH
state: Ile-de-France
Study officials:
References: