Conversational Hypnosis for Peripherical Veinous Access (HYPNACESS)

Vascular Access Site Pain Clinical Trial

— HYPNACESS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04358094
• Other study ID #: 2020-A00187-32
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 4, 2020
• Est. completion date: January 18, 2021

Study information

• Verified date: April 2020
• Source: Central Hospital, Nancy, France
• Contact: Hervé Bouaziz, Pr
• Phone: 0383851403
• Email: h.bouaziz[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: January 18, 2021
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Vascular Access Site Pain

Intervention

Other:
• Conversational hypnosis script
Conversational hypnosis during peripherical veinous catheter set up
• Standard script
Standard script during peripherical veinous catheter set up

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Auquier P, Pernoud N, Bruder N, Simeoni MC, Auffray JP, Colavolpe C, François 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. — View Citation

Ferreira-Valente MA, Pais-Ribeiro JL, Jensen MP. Validity of four pain intensity rating scales. Pain. 2011 Oct;152(10):2399-404. doi: 10.1016/j.pain.2011.07.005. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Heart rate	maximum heart rate	during the procedure
Secondary	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