Interest of Audiovisual Distraction in the Management of Anxiety and Pain During Oocyte Retrieval (Happy-Fiv)

CMC Ambroise Paré

Status: Completed

Conditions: Fertilization in Vitro

Treatments: Device: HappyMed Video Glasses; Drug: Sufentanil; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT04213781

2019/02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Usual care

Other group

Description:

Sedation according to Dixon's up-and-down method.

Treatment:

Drug: Sufentanil

Drug: Propofol

Audiovisual distraction

Experimental group

Description:

Audiovisual distraction using HappyMed Video Glasses during procedure. Sedation according to Dixon's up-and-down method.

Treatment:

Device: HappyMed Video Glasses

Drug: Sufentanil

Drug: Propofol