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Clinical Trials/NCT04711278
NCT04711278
Completed
Not Applicable

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country106 target enrollmentJanuary 7, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hallux Valgus
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
106
Locations
1
Primary Endpoint
Anxiety assessment at baseline
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 7, 2021
End Date
May 17, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Anxiety assessment at baseline

Time Frame: baseline, pre-intervention

The State Trait Anxiety Inventory (STAI) will be used to measure anxiety levels.

Anxiety assessment after the surgery

Time Frame: immediately after the surgery

The State Trait Anxiety Inventory (STAI) will be used to measure anxiety levels.

Secondary Outcomes

  • Analgesic taken(at the end of study, an average of 1 day)
  • Duration of stay(at the end of study, an average of 1 day)
  • Pain assessment(day 1)

Study Sites (1)

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