Hand Injuries
Conditions
Brief summary
Ultrasound-guided infiltration is a common procedure and is known to be locally painful. This care-induced pain leads to strong apprehension in patients who need to benefit from this procedure. The practice of hypnosis to improve the patient's comfort during a treatment has appeared progressively in hospital departments. Among the various existing conversational hypnosis techniques, there is the magic glove technique. This is the technique that will be used in this study. The investigators wish to evaluate the interest of hypnosis on the pain felt by the patient when performing an echo-guided infiltration of the hand, one of the most painful extremities during infiltrations.
Interventions
PROCEDUREHypnosis
conversational hypnosis technique call the magic glove
PROCEDUREInfiltration
Ultrasound-guided hand infiltration
Sponsors
Centre Hospitalier Departemental Vendee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with an indication of a first hand infiltration under ultrasound examination * Major patient * Patient with capacity to understand the protocol and has given oral consent to participate in the research, * Patient with social security coverage.
Exclusion criteria
* Patient having preventively applied a pain patch to the area to be infiltrated * Contraindication to infiltrations ( imbalanced diabetes, imbalanced,hypertension, ongoing infections). * Hearing impaired patient * Patient under guardianship/curtel * Minor * Pregnant woman * Patient participating in another intervention research protocol * Patient unable to follow the protocol as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the Pain Felt in Patients Who Have Benefited From a Hypnosis Session Before a Hand Infiltration Versus Hand Infiltration Without Hypnosis | 5 minutes after ultrasound-guided infiltration of hand | Analogical visual scale of pain (VAS) To 0mm (no pain) form 10 mm (maximum pain imaginable) |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Infiltration Ultrasound-guided hand infiltration
Infiltration: Ultrasound-guided hand infiltration | 40 |
| Hypnosis Hypnosis before Ultrasound-guided hand infiltration
Hypnosis: conversational hypnosis technique call the magic glove
Infiltration: Ultrasound-guided hand infiltration | 39 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 1 |
Baseline characteristics
| Characteristic | Infiltration | Hypnosis | Total |
|---|---|---|---|
| Age, Continuous | 60 Years STANDARD_DEVIATION 11 | 62 Years STANDARD_DEVIATION 10 | 61 Years STANDARD_DEVIATION 11 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 26 Participants | 27 Participants | 53 Participants |
| Sex: Female, Male Male | 14 Participants | 12 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Evaluate the Pain Felt in Patients Who Have Benefited From a Hypnosis Session Before a Hand Infiltration Versus Hand Infiltration Without Hypnosis
Analogical visual scale of pain (VAS) To 0mm (no pain) form 10 mm (maximum pain imaginable)
Time frame: 5 minutes after ultrasound-guided infiltration of hand
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Infiltration | Evaluate the Pain Felt in Patients Who Have Benefited From a Hypnosis Session Before a Hand Infiltration Versus Hand Infiltration Without Hypnosis | 4.56 units on a scale | Standard Deviation 2.71 |
| Hypnosis | Evaluate the Pain Felt in Patients Who Have Benefited From a Hypnosis Session Before a Hand Infiltration Versus Hand Infiltration Without Hypnosis | 1.75 units on a scale | Standard Deviation 1.63 |
p-value: <0.001t-test, 2 sided