Conversational Hypnosis for Peripherical Veinous Access (HYPNACESS) (HYPNACESS)

Analgesia Assessment of Conversational Hypnosis Script During Peripherical Veinous Catheter Set up Versus Standard Script in Operating Room

The peripherical veinous catheterization is required for anesthesia. However, it's a painful procedure and causes stress or even phobia.

Hypnosis can be seen as an interesting tool. Conversational hypnosis needs no training. It is used by script, which makes it easier.

The working hypothesis for study is that the conversational hypnosia script reduces pain during the set up of peripherical veinous access.

The main objective is the analgesia assessment of conversational hypnosis script for peripherical veinous catheter set up versus standard script in operating room. A nurse anesthetist is reading the conversational script or standard script during the procedure. The nurse anesthetist is untrained for hypnosis.

The secondary objective are the level of anxiety, patient satisfaction within the perioperative period (EVAN G questionnaire), the heart rate and the evaluation how nurse anesthetist feels about using the script after each use.

Study Overview

• Status: Unknown
• Conditions: Vascular Access Site Pain
• Intervention / Treatment: Other: Conversational hypnosis script; Other: Standard script

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hervé Bouaziz, Pr; Phone Number: 0383851403; Email: h.bouaziz@chru-nancy.fr

Study Locations

• France
  • Nancy, France, 54000
    • Centre hospitalier régional universitaire
    • Contact: Hervé Bouaziz, Pr; Phone Number: 0383851403; Email: h.bouaziz@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Digestive endoscopy procedure under general anesthesia in one of the participating centers
• Patient speaking and understanding French
• Patient affiliated or entitled to a social security scheme
• Patient who received enlightened information about the study and who co-signed, with the investigator, a consent to participate after a minimum period of reflection

Exclusion Criteria:

• Patient with deafness
• Patient with cognitive impairment
• Pregnant and / or breastfeeding patient
• Patient with dissociative disorders (contraindication to hypnosis)
• Patient suffering from a pathology which can cause chronic pain
• Patient receiving analgesia or anxiety drug
• Patient under justice, curatorship or tutorship
• Patient deprived of liberty by judicial or administrative decision

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Conversational hypnosis script; Patient who received conversational hypnosis script during peripherical veinous access set up	Other: Conversational hypnosis script; Conversational hypnosis during peripherical veinous catheter set up
Other: Standard script; Patient who received standard script during peripherical veinous access set up	Other: Standard script; Standard script during peripherical veinous catheter set up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesia assessment by digital pain scale	Digital pain scale: it describes the severity of the pain On this scale, "0" represents "no pain" and "10" represents "the worst possible pain"	immediately after applying the peripherical veinous catheter dressing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of anxiety by numerical scale	Digital scale: it describes the severity of the pain On this scale, "0" represents "no anxiety" and "10" represents "the worst possible anxiety"	before randomization and immediately after peripherical veinous catheter set up
patient satisfaction within the perioperative period (EVAN G questionnaire)	EVAN G questionnaire: Score from 0 to 100 The higher the score, the higher the level of patient satisfaction	between 4 and 48 hours after the procedure
Heart rate	maximum heart rate	during the procedure
Nurse anesthetist feeling about using the script after each use by digital scale	Evaluate how nurse anesthetist feels about using the script after each use by digital scale ranging from 0 to 10. On this scale, "0" represents " uncomfortable" and "10" represents " very comfortable "	immediately after procedure

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Hervé Bouaziz, Pr, Centre Hospitalier Régional Universitaire de Nancy

Publications and helpful links

General Publications

• Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-2404. doi: 10.1016/j.pain.2011.07.005.
• Auquier P, Pernoud N, Bruder N, Simeoni MC, Auffray JP, Colavolpe C, Francois G, Gouin F, Manelli JC, Martin C, Sapin C, Blache JL. Development and validation of a perioperative satisfaction questionnaire. Anesthesiology. 2005 Jun;102(6):1116-23. doi: 10.1097/00000542-200506000-00010.
• Armstrong P, Young C, McKeown D. Ethyl chloride and venepuncture pain: a comparison with intradermal lidocaine. Can J Anaesth. 1990 Sep;37(6):656-8. doi: 10.1007/BF03006485.
• Nir Y, Paz A, Sabo E, Potasman I. Fear of injections in young adults: prevalence and associations. Am J Trop Med Hyg. 2003 Mar;68(3):341-4.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 4, 2020
• Primary Completion (Anticipated): December 30, 2020
• Study Completion (Anticipated): January 18, 2021

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 21, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2020-A00187-32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No