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| Name | Class |
|---|---|
| Vivactis M2Research | INDUSTRY |
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This is a single-center, prospective, randomized, open-label study of two parallel groups of patients undergoing hand surgery:
Group 1: locoregional anesthesia + neuroleptanalgesia Group 2: locoregional anesthesia + hypnoanalgesia Therapeutic benefit is based on VAS assessment of intraoperative anxiety.
In a population of patients undergoing hand surgery and divided into two groups according to the anesthesia protocol administered in addition to locoregional anesthesia by truncal block:
Group 1: neuroleptanalgesia Group 2: hypnoanalgesia Primary objective The main objective of the study is to compare changes in preoperative anxiety between the two groups, between two measurements taken preoperatively (before anxiety management) and at the end of surgery. This level will be evaluated using a VAS rated from 0 to 10.
Secondary objectives
Comparing groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual neuroleptanalgesic treatment | Active Comparator | Usual neuroleptanalgesic treatment Hypnovel (1 mg if weight < 60 kg, 1.5 mg if weight between 60 and 80 kg, 2 mg if weight > 80 kg) |
|
| Hypnoanalgesia | Experimental | Patients in this group will begin their hypnoanalgesia session with a nurse trained in hypnotherapy. Various methods commonly used in hypnosis (VAKOG, dissociation, diversion, metaphors, etc.) will be selected based on the patient, their personality, their expectations, and their degree of suggestibility. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuroleptanalgesic treatment | Drug | Usual neuroleptanalgesic treatment Hypnovel and Locoregional anesthesia |
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| Measure | Description | Time Frame |
|---|---|---|
| VAS anxiety score | Changes in VAS anxiety score between preoperative and intraoperative assessment. Anxiety will be assessed on a visual analog scale measuring 10 cm (with 0 = no stress - 10 = major stress) and by administering the APAIS scale. | Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity assessment | Pain intensity will be assessed using a simple numerical scale (ENS) graduated from 0 (no pain) to 10 (worst pain imaginable). | Day 0 |
| Pain intensity assessment | Pain intensity will be assessed using a simple numerical scale (ENS) graduated from 0 (no pain) to 10 (worst pain imaginable). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mélanie FROMENTIN, MD | Contact | 01 86 86 66 00 | 33 | mfromentin.anesthesierea@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mélanie FROMENTIN, MD | Hôpital Privé Paul d'Egine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Privé Paul d'Egine | Recruiting | Champigny-sur-Marne | 94500 | France |
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Single-center, prospective, randomized, open label study with two parallel groups of patients.
Maximum duration of patient participation = 3 days.
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| Hypnoanalgesia | Other | Hypnoanalgesia and Locoregional anesthesia |
|
| Day 2 |
| Overall patient satisfaction | Overall patient satisfaction will be assessed using a simple numerical scale (ENS) graduated from 0 (not at all satisfied) to 10 (completely satisfied). | Day 0 |
| Overall patient satisfaction | Overall patient satisfaction will be assessed using a simple numerical scale (ENS) graduated from 0 (not at all satisfied) to 10 (completely satisfied). | Day 2 |
| Treatment Safety | The safety will be assessed by collecting data on adverse events occurring during the study. | Day 2 |