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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04711278

Acronym

PACAH-UCA HV

Enrollment

106

Registered

2021-01-15

Start date

2021-01-07

Completion date

2022-05-17

Last updated

2025-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallux Valgus, Surgery

Keywords

hallux valgus, hypnosis, pre-operative anxiety, surgery

Brief 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.

Detailed 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.

Interventions

DEVICEMask-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.

OTHERWithout hypnosis

No hypnosis during surgery of Hallux valgus.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Anxiety assessment at baseline	baseline, pre-intervention	The State Trait Anxiety Inventory (STAI) will be used to measure anxiety levels.
Anxiety assessment after the surgery	immediately after the surgery	The State Trait Anxiety Inventory (STAI) will be used to measure anxiety levels.

Secondary

Measure	Time frame	Description
Analgesic taken	at the end of study, an average of 1 day	Dose of analgesic taken will be added up.
Duration of stay	at the end of study, an average of 1 day	Duration of stay before discharge of hospital.
Pain assessment	day 1	EVA score, a french auto evaluation tool will be used for pain.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026