Conversational Hypnosis for Peripherical Veinous Access (HYPNACESS)

NCT04358094 | Unknown

• 1 other identifier: 2020-A00187-32
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vascular Access Site Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Level of anxiety by numerical scale

  before randomization and immediately after peripherical veinous catheter set up

• patient satisfaction within the perioperative period (EVAN G questionnaire)

  between 4 and 48 hours after the procedure

• Heart rate

  during the procedure

• Nurse anesthetist feeling about using the script after each use by digital scale

  immediately after procedure

Study Arms (2)

Conversational hypnosis script

EXPERIMENTAL

Patient who received conversational hypnosis script during peripherical veinous access set up

Other: Conversational hypnosis script

Standard script

OTHER

Patient who received standard script during peripherical veinous access set up

Other: Standard script

Interventions

Conversational hypnosis script OTHER

Conversational hypnosis during peripherical veinous catheter set up

Conversational hypnosis script

Standard script OTHER

Standard script during peripherical veinous catheter set up

Standard script

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Centre Hospitalier Régional Universitaire

Nancy, 54000, France

Location

Related Publications (4)

• 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.

  PMID: 2208537 BACKGROUND

• 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.

  PMID: 12685642 BACKGROUND

• 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.

  PMID: 21856077 BACKGROUND

• 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.

  PMID: 15915023 BACKGROUND

Study Officials

• Hervé Bouaziz, Pr

  Central Hospital, Nancy, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hervé Bouaziz, Pr

CONTACT

0383851403; h.bouaziz@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: April 22, 2020
• Study Start: May 4, 2020
• Primary Completion: December 30, 2020
• Study Completion: January 18, 2021
• Last Updated: April 22, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)