Using Virtual Reality to Prevent Pre-operative Anxiety in Ambulatory Surgery Patients (PACAH-UCA HV)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Hallux Valgus; Surgery

Treatments: Other: Without hypnosis; Device: Mask-wearing hypnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT04711278

2019-A03316-51 (Registry Identifier)

APHP201445

Details and patient eligibility

About

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

Full 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.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

hypnosis group

Experimental group

Description:

Mask-wearing as hypnosis method for patients in this arm.

Treatment:

Device: Mask-wearing hypnosis

comparator group

Sham Comparator group

Description:

No hypnosis for patients in this arm.

Treatment:

Other: Without hypnosis