Clinical trial NCT05623449: Teleconsultations Hypnosis Sessions for Patients with Peripheral Chronic Neuropathic Pain
Official title: Monocentric Pilot Study of the Feasibility of Teleconsultations Hypnosis Sessions Led by a Nurse for Patients with Peripheral Chronic Neuropathic Pain - HYPTEC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Neuropathy
Pain
Keywords: peripheral chronic neuropathic pain
hypnosis
teleconsultations
feasability
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 5 hypnosis consultations (in face-to-face and by teleconsultation).
timeFrame: Month 8
Secondary outcomes:
measure: Achievement/Acceptability
timeFrame: Month 8
measure: Numerical Pain Assessme
timeFrame: Day 0, month 1, month 2, month 3 month 4 and montth 7
measure: Hospital Anxiety and Depression scale (HAD)
timeFrame: Day 0, month 4 and month 7
measure: Learning self-hypnosis
timeFrame: Day 0, month 1, month 2, month 3 month 4 and montth 7
measure: Ssatisfaction scale
timeFrame: Month 7
Other outcomes:
Locations:
city: Pessac
country: France
facility: Université Hospital, Bordeaux
Study officials:
affiliation: Université Hospital, Bordeaux
name: Jennie SOURZAC
role: PRINCIPAL_INVESTIGATOR
References: