Ignite Creation Date:
2024-07-17 @ 10:52 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06497712
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-05-29
Brief Title:
BEnefit of HYpnosis on Pain During Stitches in Emergency Room
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
BEnefit of HYpnosis on Pain During Stitches in Emergency Room The BE-HYPER Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BE-HYPER
Brief Summary:
Suturing is a daily practice in the emergency department but it can be painful and stressful for patients Hypnosis is increasingly used as a complement to the usual painkillers The aim of our study was to investigate the impact of hypnosis on stitch placement in emergency department patients presenting with lacerations assessed by heart rate variability
Detailed Description:
The aim of this randomized controlled single-center prospective study is to evaluate the impact of hypnosis during suturing in emergency department patients presenting with a laceration assessed by heart rate variability
All patients with eligibility criteria will be included if the patient gave his written consent
Patients will be randomized to one of two arms 1 Hypnosis or 2 Standard Of Care SOC A heart rate monitoring belt will be fitted to the patient for both groups The patient will be asked to complete a self-assessment questionnaire on pain and stress as well as socio-demographic parameters
A blood sample will be collected and the heart rate and blood pressure will be measured
Stitches will be taken with or without hypnosis and after 30 minutes the pain and stress self-assessment questionnaire will again be completed by the patient and a new blood test will be taken
the heart rate monitoring belt will be removed and the study will be completed for the patient
All patients with eligibility criteria will be included if the patient gave his written consent
Patients will be randomized to one of two arms 1 Hypnosis or 2 Standard Of Care SOC A heart rate monitoring belt will be fitted to the patient for both groups The patient will be asked to complete a self-assessment questionnaire on pain and stress as well as socio-demographic parameters
A blood sample will be collected and the heart rate and blood pressure will be measured
Stitches will be taken with or without hypnosis and after 30 minutes the pain and stress self-assessment questionnaire will again be completed by the patient and a new blood test will be taken
the heart rate monitoring belt will be removed and the study will be completed for the patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None