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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A03316-51 | Registry Identifier | IDRCB |
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The primary objective is to evaluate the impact on pre-operative anxiety management of using the virtual reality mask for surgery of hallux valgus.
As secondary objectives, the study aims
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hypnosis group | Experimental | Mask-wearing as hypnosis method for patients in this arm. |
|
| comparator group | Sham Comparator | No hypnosis for patients in this arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety assessment at baseline | The State Trait Anxiety Inventory (STAI) will be used to measure anxiety levels. | baseline, pre-intervention |
| Anxiety assessment after the surgery | The State Trait Anxiety Inventory (STAI) will be used to measure anxiety levels. | immediately after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesic taken | Dose of analgesic taken will be added up. | at the end of study, an average of 1 day |
| Duration of stay | Duration of stay before discharge of hospital. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christophe MENIGAUX, MD | Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP | Principal Investigator |
| Marie-Hélène SANDIFORD | Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Orthopaedics and Traumatology, Ambroise Paré hospital, APHP | Boulogne-Billancourt | 92100 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29317347 | Background | Ganry L, Hersant B, Sidahmed-Mezi M, Dhonneur G, Meningaud JP. Using virtual reality to control preoperative anxiety in ambulatory surgery patients: A pilot study in maxillofacial and plastic surgery. J Stomatol Oral Maxillofac Surg. 2018 Sep;119(4):257-261. doi: 10.1016/j.jormas.2017.12.010. Epub 2018 Jan 6. |
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| ID | Term |
|---|---|
| D006215 | Hallux Valgus |
| ID | Term |
|---|---|
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D006990 | Hypnosis |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
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| Without hypnosis | Other | No hypnosis during surgery of Hallux valgus. |
|
| at the end of study, an average of 1 day |
| Pain assessment | EVA score, a french auto evaluation tool will be used for pain. | day 1 |
| D004191 |
| Behavioral Disciplines and Activities |