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Completed

NCT Number: NCT04213781

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

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.

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Key information

Conditions

Fertilization in Vitro

Age range

18 year–43 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hopital FOCH

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HappyMed Video Glasses

Device

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

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.

Sufentanil

Drug

0.1 µg/kg

Primary outcomes

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

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

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

Secondary outcomes

  1. Side effects due to audiovisual distraction

    Time frame: 4 hours

    Onset of vertigo, nausea or headaches

  2. Patient comfort during propofol injection

    Time frame: 30 minutes

    Comfort behavior scale : it incorporates three categories of behavior : Facial expression (0=relaxed ; 1= frowning ; 2=grimacing) ; Verbal response (0=none ; 1= moans ; 2=verbal protest) ; Arm movement (0=none ; 1=medium ; 2=strong). Each scored on a 0-2-point scale so that the total score ranges from 0 to 6.

  3. Complications due to anaesthesia

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

    Occurence of desaturation event (SpO2< 92%), respiratory distress event (RR<10 breaths per minute) or bronchospasm.

  4. Resumption of walking

    Time frame: 12 hours

    Duration between the end of the procedure and the standing position.

  5. Health staff satisfaction

    Time frame: 2 hours

    Satisfaction VRS ranging from 0 to 4 (0=unsatisfied, 4=very satisfied).

  6. Patient satisfaction

    Time frame: 4 hours

    Satisfaction VRS ranging from 0 to 4 (0=unsatisfied, 4=very satisfied).

  7. Resuming activities of daily living

    Time frame: 24 hours

    Numeric scale from 0 to 10 (0=bedridden, 10=resuming total activities).

Sponsors and collaborators

Lead sponsor

CMC Ambroise Paré

Other

Registry information

Official study title

Does Audiovisual Distraction Decrease the Use of Hypnotic Drugs During Oocyte Retrieval?

Acronym: Happy-Fiv

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 30, 2019
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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