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OpenTrials
Completed

NCT Number: NCT04711278

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP

Boulogne-Billancourt, 92100, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mask-wearing hypnosis

Device

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.

Without hypnosis

Other

No hypnosis during surgery of Hallux valgus.

Primary outcomes

  1. Anxiety assessment at baseline

    Time frame: baseline, pre-intervention

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

  2. 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

  1. Analgesic taken

    Time frame: at the end of study, an average of 1 day

    Dose of analgesic taken will be added up.

  2. Duration of stay

    Time frame: at the end of study, an average of 1 day

    Duration of stay before discharge of hospital.

  3. Pain assessment

    Time frame: day 1

    EVA score, a french auto evaluation tool will be used for pain.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: PACAH-UCA HV

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 15, 2021
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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