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

Not Applicable

Completed

• Conditions: Fertilization in Vitro
• Interventions: Device: HappyMed Video Glasses; Drug: Propofol; Drug: Sufentanil

• Registration Number: NCT04213781
• Lead Sponsor: CMC Ambroise Paré

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.

Study Timeline

• Study First Submitted: 2019-12-27
• Study First Submitted QC: 2019-12-27
• Study First Posted: 2019-12-30
• Study Start: 2020-09-23
• Primary Completion: 2020-11-24
• Study Completion: 2020-11-25
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-14
• Last Update Posted: 2021-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Audiovisual distraction	HappyMed Video Glasses	Audiovisual distraction using HappyMed Video Glasses during procedure. Sedation according to Dixon's up-and-down method.
Usual care	Propofol	Sedation according to Dixon's up-and-down method.
Usual care	Sufentanil	Sedation according to Dixon's up-and-down method.
Audiovisual distraction	Propofol	Audiovisual distraction using HappyMed Video Glasses during procedure. Sedation according to Dixon's up-and-down method.
Audiovisual distraction	Sufentanil	Audiovisual distraction using HappyMed Video Glasses during procedure. Sedation according to Dixon's up-and-down method.

Primary Outcome Measures

Name	Time	Method
Target concentration of propofol administered during oocyte retrieval procedure to maintain the patient comfortable	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 Outcome Measures

Name	Time	Method
Resumption of walking	12 hours	Duration between the end of the procedure and the standing position.
Health staff satisfaction	2 hours	Satisfaction VRS ranging from 0 to 4 (0=unsatisfied, 4=very satisfied).
Patient satisfaction	4 hours	Satisfaction VRS ranging from 0 to 4 (0=unsatisfied, 4=very satisfied).
Patient comfort during propofol injection	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.
Complications due to anaesthesia	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.
Side effects due to audiovisual distraction	4 hours	Onset of vertigo, nausea or headaches
Resuming activities of daily living	24 hours	Numeric scale from 0 to 10 (0=bedridden, 10=resuming total activities).

Trial Locations

Locations (1)

Hopital FOCH; 🇫🇷 Suresnes, Ile-de-France, France