Interest of Audiovisual Distraction in the Management of Anxiety and Pain During Oocyte Retrieval

NCT ID: NCT04213781

Last Updated: 2021-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-23
• Study Completion Date: 2020-11-25

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.

Conditions

Fertilization in Vitro

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Usual care

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

Group Type: OTHER

Propofol

Intervention Type: DRUG

The dosage is modified according to the Dixon's up-and-down method (using 0.5 µg/ml as a step size). The first patient in each group will start at a dose 3 µg/ml propofol. If patient manifests discomfort then the next patient will receive an increment of 0.5 µg/ml propofol, if patient is comfortable, then the next patient received a decrement of 0.5 µg/ml propofol.

Sufentanil

Intervention Type: DRUG

0.1 µg/kg

Audiovisual distraction

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

Group Type: EXPERIMENTAL

HappyMed Video Glasses

Intervention Type: DEVICE

HappyMed allows the immersion of patients in films, cartoons or concerts.

Propofol

Intervention Type: DRUG

The dosage is modified according to the Dixon's up-and-down method (using 0.5 µg/ml as a step size). The first patient in each group will start at a dose 3 µg/ml propofol. If patient manifests discomfort then the next patient will receive an increment of 0.5 µg/ml propofol, if patient is comfortable, then the next patient received a decrement of 0.5 µg/ml propofol.

Sufentanil

Intervention Type: DRUG

0.1 µg/kg

Interventions

HappyMed Video Glasses

HappyMed allows the immersion of patients in films, cartoons or concerts.

Intervention Type: DEVICE

Propofol

The dosage is modified according to the Dixon's up-and-down method (using 0.5 µg/ml as a step size). The first patient in each group will start at a dose 3 µg/ml propofol. If patient manifests discomfort then the next patient will receive an increment of 0.5 µg/ml propofol, if patient is comfortable, then the next patient received a decrement of 0.5 µg/ml propofol.

Intervention Type: DRUG

Sufentanil

0.1 µg/kg

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CMC Ambroise Paré

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital FOCH

Suresnes, Île-de-France Region, France

Countries

France

Other Identifiers

2019/02

Identifier Type: -

Identifier Source: org_study_id