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

Fertilization in Vitro Clinical Trial

— Happy-Fiv  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04213781
• Other study ID #: 2019/02
• Status: Completed
• Phase: N/A
• Start date: September 23, 2020
• Est. completion date: November 25, 2020

Study information

• Verified date: January 2021
• Source: CMC Ambroise Paré
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 25, 2020
• Est. primary completion date: November 24, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertilization in Vitro

Intervention

Device:
• HappyMed Video Glasses
HappyMed allows the immersion of patients in films, cartoons or concerts.

Drug:
• 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.
• Sufentanil
0.1 µg/kg

Locations

Country	Name	City	State
France	Hopital FOCH	Suresnes	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
CMC Ambroise Paré

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Side effects due to audiovisual distraction	Onset of vertigo, nausea or headaches	4 hours
Secondary	Patient comfort during propofol injection	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.	30 minutes
Secondary	Complications due to anaesthesia	Occurence of desaturation event (SpO2< 92%), respiratory distress event (RR<10 breaths per minute) or bronchospasm.	up to 24 hours (from the start of anaesthesia to the patient's discharge of the recovery room)
Secondary	Resumption of walking	Duration between the end of the procedure and the standing position.	12 hours
Secondary	Health staff satisfaction	Satisfaction VRS ranging from 0 to 4 (0=unsatisfied, 4=very satisfied).	2 hours
Secondary	Patient satisfaction	Satisfaction VRS ranging from 0 to 4 (0=unsatisfied, 4=very satisfied).	4 hours
Secondary	Resuming activities of daily living	Numeric scale from 0 to 10 (0=bedridden, 10=resuming total activities).	24 hours