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

NCT04213781 | Completed

• 1 other identifier: 2019/02
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Fertilization in Vitro

Keywords

Oocyte retrieval; Sedation

Outcome Measures

Primary Outcomes (1)

• Target concentration of propofol administered during oocyte retrieval procedure to maintain the patient comfortable

  An up and down method will define the CP 50 in each group.

  Intraoperative period : from the start of anaesthesia to the end of the intervention

Secondary Outcomes (7)

• Side effects due to audiovisual distraction

  4 hours

• Patient comfort during propofol injection

  30 minutes

• Complications due to anaesthesia

  up to 24 hours (from the start of anaesthesia to the patient's discharge of the recovery room)

• Resumption of walking

  12 hours

• Health staff satisfaction

  2 hours

Study Arms (2)

Usual care

OTHER

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

Drug: Propofol; Drug: Sufentanil

Audiovisual distraction

EXPERIMENTAL

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

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

Interventions

HappyMed Video Glasses DEVICE

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

Audiovisual distraction

Propofol 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.

Audiovisual distraction; Usual care

Sufentanil DRUG

0.1 µg/kg

Audiovisual distraction; Usual care

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• CMC Ambroise Paré: lead

Study Sites (1)

Hopital FOCH

Suresnes, Île-de-France Region, 92151, France

Location

Related Publications (1)

• Trou B, Pirtea P, Ma S, Aime I, Gross T, Kennel T, Jean-Marc A, Fischler M, Squara P, Le Guen M. Impact of pre-operative audiovisual distraction on consumption of hypnotics during transvaginal oocyte retrieval: A randomised controlled trial. Eur J Anaesthesiol. 2023 Aug 1;40(8):608-610. doi: 10.1097/EJA.0000000000001866. Epub 2023 Jun 22. No abstract available.

  PMID: 37345747 RESULT

MeSH Terms

Interventions

Propofol; Sufentanil

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2019
• First Posted: December 30, 2019
• Study Start: September 23, 2020
• Primary Completion: November 24, 2020
• Study Completion: November 25, 2020
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)