Teleconsultations Hypnosis Sessions for Patients with Peripheral Chronic Neuropathic Pain (HYPTEC)

Monocentric Pilot Study of the Feasibility of Teleconsultations Hypnosis Sessions Led by a Nurse for Patients with Peripheral Chronic Neuropathic Pain - HYPTEC

The aim of this study is to assess the feasibility of hypnosis sessions performed in teleconsultations and led by a nurse, for patients with peripheral chronic neuropathic pain. Acceptability, satisfaction and effects (on pain and psychological distress) are also evaluated, comparing patients who have benefited from teleconsultations and those who did not.

Study Overview

• Status: Completed
• Conditions: Pain; Peripheral Neuropathy
• Intervention / Treatment: Other: Clinical examination; Other: Anxiety and Depression Scale (HAD); Procedure: pain scale; Procedure: hypnosis consultation; Procedure: Maintenance; Other: Data collection

Detailed Description

Factors explaining peripheral chronic neuropathic pains are complex ; they require a personalized therapeutic strategy and multidisciplinary management. Among the recommended management, psychocorporal approaches such as hypnosis, are subject of recent interest. At the CHU de Bordeaux, the management of patients suffering from such chronic pains, consists of 5 hypnosis sessions, conducted face-to-face, each performed one month apart : the first session is carried out by a doctor and a hypnotherapist nurse and the 4 following sessions by the hypnotherapist nurse alone. However, it seems that this usual management is not easily accessible for patients who are geographically distant and/or who are unable to move due to excessive pain. In such situations, teleconsultations would avoid travel for these patients with low mobility and then would an interesting alternative to face-to-face consultations. Few studies have been done on hypnosis sessions led by teleconsultations. So, the whole purpose of this study is to compare the management of 15 patients by teleconsultations (experimental arm) with 15 other patients seen in face-to-face (control arm) to evaluate feasibility of teleconsultation in hypnosis.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pessac, France, 33600
    • Université Hospital, Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient aged over 18 years old,
• Patient suffering of from peripheral neuropathic pain for more than 1 year,
• Patient referred for hypnosis management as part of a coordinated care support,
• Patient who accepts teleconsultation, having the appropriate equipment to attend teleconsultations (computer, microphone, camera and stable internet connection with sufficient internet speed) and the ability to use it independently,
• Patient having signed a free, informed and written consent,
• Patient affiliated or beneficiary of the social security system.

Exclusion Criteria:

• Patient with severe and unstable neurocognitive or psychiatric conditions (depression, psychoses, major cognitive impairments),
• Patient with uncorrected deafness,
• Patient with poor understanding of French
• Patient placed under judicial safeguard, guardianship or curatorship.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: combination of face-to-face and teleconsultation hypnosis consultation; The first and the last hypnosis sessions in face-to-face, and the other 3 intermediate sessions being conducted by teleconsultation.	Other: Clinical examination; Current medications (only those prescribed to treat pain, anxiety and depression), non-drug treatment(s) prior to treatment in hypnosis as well as any ongoing treatment(s).; Other: Anxiety and Depression Scale (HAD); To screen for anxious and depressive symptoms; Procedure: pain scale; Measurement of pain intensity; Procedure: hypnosis consultation; 5 hypnosis consultation; Procedure: Maintenance; Qualitative assessment; Other: Data collection; Age, sex, socio-professional category, level of education, comorbidities, date of diagnosis of chronic peripheral neuropathic pain, distance between home and hospital.
Active Comparator: face-to-face hypnosis consultation; 5 face-to-face hypnosis sessions	Other: Clinical examination; Current medications (only those prescribed to treat pain, anxiety and depression), non-drug treatment(s) prior to treatment in hypnosis as well as any ongoing treatment(s).; Other: Anxiety and Depression Scale (HAD); To screen for anxious and depressive symptoms; Procedure: pain scale; Measurement of pain intensity; Procedure: hypnosis consultation; 5 hypnosis consultation; Procedure: Maintenance; Qualitative assessment; Other: Data collection; Age, sex, socio-professional category, level of education, comorbidities, date of diagnosis of chronic peripheral neuropathic pain, distance between home and hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
5 hypnosis consultations (in face-to-face and by teleconsultation).	The rate (%) of included patients who have completed the 5 hypnosis consultations (in face-to-face and by teleconsultation).	Month 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achievement/Acceptability	Acceptance rate (%) of the proposal to participate in the study in the two study arms: face-to-face hypnosis care (control arm) and care including hypnosis teleconsultations (experimental arm).	Month 8
Numerical Pain Assessme	Mean difference in pain score, minimum value is 0 and maximum value is 10	Day 0, month 1, month 2, month 3 month 4 and montth 7
Hospital Anxiety and Depression scale (HAD)	Mean difference in the anxiety and depression score, minimum value is 0 and maximum value is 42	Day 0, month 4 and month 7
Learning self-hypnosis	Evaluate the frequency of the use of self-hypnosis throughout the treatment.	Day 0, month 1, month 2, month 3 month 4 and montth 7
Ssatisfaction scale	Evaluate the level of satisfaction and the feeling of the patients with regard to the nursing care in hypnosis at the end of the care in the two study arms (face-to-face control arm and experimental arm with teleconsultations).	Month 7

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Jennie SOURZAC, Université Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2023
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: October 27, 2022
• First Submitted That Met QC Criteria: November 17, 2022
• First Posted (Actual): November 21, 2022

Study Record Updates

• Last Update Posted (Estimated): November 25, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: hypnosis; feasability; peripheral chronic neuropathic pain; teleconsultations
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Neuralgia; Peripheral Nervous System Diseases
• Other Study ID Numbers: CHUBX 2022/34

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No