Teleconsultations Hypnosis Sessions for Patients with Peripheral Chronic Neuropathic Pain

Not Applicable

Completed

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

• Registration Number: NCT05623449
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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.

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 Timeline

• Study First Submitted: 2022-10-27
• Study First Submitted QC: 2022-11-17
• Study First Posted: 2022-11-21
• Study Start: 2023-02-23
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
face-to-face hypnosis consultation	Anxiety and Depression Scale (HAD)	5 face-to-face hypnosis sessions
combination of face-to-face and teleconsultation hypnosis consultation	Anxiety and Depression Scale (HAD)	The first and the last hypnosis sessions in face-to-face, and the other 3 intermediate sessions being conducted by teleconsultation.
combination of face-to-face and teleconsultation hypnosis consultation	Clinical examination	The first and the last hypnosis sessions in face-to-face, and the other 3 intermediate sessions being conducted by teleconsultation.
combination of face-to-face and teleconsultation hypnosis consultation	Data collection	The first and the last hypnosis sessions in face-to-face, and the other 3 intermediate sessions being conducted by teleconsultation.
combination of face-to-face and teleconsultation hypnosis consultation	pain scale	The first and the last hypnosis sessions in face-to-face, and the other 3 intermediate sessions being conducted by teleconsultation.
face-to-face hypnosis consultation	Clinical examination	5 face-to-face hypnosis sessions
combination of face-to-face and teleconsultation hypnosis consultation	hypnosis consultation	The first and the last hypnosis sessions in face-to-face, and the other 3 intermediate sessions being conducted by teleconsultation.
combination of face-to-face and teleconsultation hypnosis consultation	Maintenance	The first and the last hypnosis sessions in face-to-face, and the other 3 intermediate sessions being conducted by teleconsultation.
face-to-face hypnosis consultation	pain scale	5 face-to-face hypnosis sessions
face-to-face hypnosis consultation	hypnosis consultation	5 face-to-face hypnosis sessions
face-to-face hypnosis consultation	Maintenance	5 face-to-face hypnosis sessions
face-to-face hypnosis consultation	Data collection	5 face-to-face hypnosis sessions

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Numerical Pain Assessme	Day 0, month 1, month 2, month 3 month 4 and montth 7	Mean difference in pain score, minimum value is 0 and maximum value is 10
Hospital Anxiety and Depression scale (HAD)	Day 0, month 4 and month 7	Mean difference in the anxiety and depression score, minimum value is 0 and maximum value is 42
Achievement/Acceptability	Month 8	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).
Learning self-hypnosis	Day 0, month 1, month 2, month 3 month 4 and montth 7	Evaluate the frequency of the use of self-hypnosis throughout the treatment.
Ssatisfaction scale	Month 7	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).

Trial Locations

Locations (1)

Université Hospital, Bordeaux; 🇫🇷 Pessac, France