Using Virtual Reality to Prevent Pre-operative Anxiety in Ambulatory Surgery Patients

Surgery Clinical Trial

— PACAH-UCA HV  

Official title:

Hypnosis Mask in Pre-operative Anxiety Management in Ambulatory Surgery Patients: Using Virtual Reality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04711278
• Other study ID #: APHP201445
• Secondary ID: 2019-A03316-51
• Status: Completed
• Phase: N/A
• Start date: January 7, 2021
• Est. completion date: May 17, 2022

Study information

• Verified date: February 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective is to evaluate the impact on pre-operative anxiety management of using the virtual reality mask for surgery of hallux valgus.

Description:

As secondary objectives, the study aims

• to evaluate post-operative analgesic according to non-drug pre-operative hypnosis, measured by reduction in analgesic intake, and by evaluate of pain;

• to evaluate factors which permitting discharge rapidly from hospital in case of hypnosis with virtual reality.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: May 17, 2022
• Est. primary completion date: May 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient = 18 years;

• Autonomous patient living at home;

• Affiliated to a social security scheme;

• Informed consent signed by patient;

• Patient will undergo a planned ambulatory surgery for hallux valgus.

Exclusion Criteria:

• Inability to understand STAI-A questionnaire;

• Patient refusal;

• Patient underwent a bilateral surgery;

• Patient judicial decision;

• Covered by french AME health system.

Related Conditions & MeSH terms

• Hallux Valgus
• Surgery

Intervention

Device:
• Mask-wearing hypnosis
Virtual mask will be worn by patients before and during surgery of Hallux valgus to realize hypnosis. Virtual mask with 2 types of voice: female voice and male voice. Several types of image or music to choice by patient.

Other:
• Without hypnosis
No hypnosis during surgery of Hallux valgus.

Locations

Country	Name	City	State
France	Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP	Boulogne-Billancourt

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Ganry L, Hersant B, Sidahmed-Mezi M, Dhonneur G, Meningaud JP. Using virtual reality to control preoperative anxiety in ambulatory surgery patients: A pilot study in maxillofacial and plastic surgery. J Stomatol Oral Maxillofac Surg. 2018 Sep;119(4):257-261. doi: 10.1016/j.jormas.2017.12.010. Epub 2018 Jan 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety assessment at baseline	The State Trait Anxiety Inventory (STAI) will be used to measure anxiety levels.	baseline, pre-intervention
Primary	Anxiety assessment after the surgery	The State Trait Anxiety Inventory (STAI) will be used to measure anxiety levels.	immediately after the surgery
Secondary	Analgesic taken	Dose of analgesic taken will be added up.	at the end of study, an average of 1 day
Secondary	Duration of stay	Duration of stay before discharge of hospital.	at the end of study, an average of 1 day
Secondary	Pain assessment	EVA score, a french auto evaluation tool will be used for pain.	day 1