Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04711278
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : March 2, 2022
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Hallux Valgus Surgery Device: Mask-wearing hypnosis Other: Without hypnosis Not Applicable

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Hypnosis Mask in Pre-operative Anxiety Management in Ambulatory Surgery Patients: Using Virtual Reality
Actual Study Start Date : January 7, 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Bunion
MedlinePlus related topics: Anxiety

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: hypnosis group
Mask-wearing as hypnosis method for patients in this arm.
 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.
Sham Comparator: comparator group
No hypnosis for patients in this arm.
 Other: Without hypnosis
No hypnosis during surgery of Hallux valgus.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04711278


Contacts
Layout table for location contacts
Contact: Christophe MENIGAUX, MD + 33 (0)1 49 09 54 30 christophe.ménigaux@aphp.fr
Contact: Marie-Hélène SANDIFORD + 33 (0)1 49 09 59 30 mh.sandiford@gmail.com

Locations
Layout table for location information
France
Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP Recruiting
Boulogne-Billancourt, France, 92100
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Layout table for investigator information
Principal Investigator: Christophe MENIGAUX, MD Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP
Study Director: Marie-Hélène SANDIFORD Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04711278    
Other Study ID Numbers: APHP201445
2019-A03316-51 ( Registry Identifier: IDRCB )
First Posted: January 15, 2021    Key Record Dates
Last Update Posted: March 2, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
hallux valgus
hypnosis
pre-operative anxiety
surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Hallux Valgus
Foot Deformities
Musculoskeletal Diseases