Teleconsultations Hypnosis Sessions for Patients with Peripheral Chronic Neuropathic Pain

NCT ID: NCT05623449

Last Updated: 2024-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-23

Study Completion Date

2024-04-30

Brief Summary

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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

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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.

Conditions

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Peripheral Neuropathy Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Clinical examination

Intervention Type OTHER

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).

Anxiety and Depression Scale (HAD)

Intervention Type OTHER

To screen for anxious and depressive symptoms

pain scale

Intervention Type PROCEDURE

Measurement of pain intensity

hypnosis consultation

Intervention Type PROCEDURE

5 hypnosis consultation

Maintenance

Intervention Type PROCEDURE

Qualitative assessment

Data collection

Intervention Type OTHER

Age, sex, socio-professional category, level of education, comorbidities, date of diagnosis of chronic peripheral neuropathic pain, distance between home and hospital.

face-to-face hypnosis consultation

5 face-to-face hypnosis sessions

Group Type ACTIVE_COMPARATOR

Clinical examination

Intervention Type OTHER

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).

Anxiety and Depression Scale (HAD)

Intervention Type OTHER

To screen for anxious and depressive symptoms

pain scale

Intervention Type PROCEDURE

Measurement of pain intensity

hypnosis consultation

Intervention Type PROCEDURE

5 hypnosis consultation

Maintenance

Intervention Type PROCEDURE

Qualitative assessment

Data collection

Intervention Type OTHER

Age, sex, socio-professional category, level of education, comorbidities, date of diagnosis of chronic peripheral neuropathic pain, distance between home and hospital.

Interventions

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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).

Intervention Type OTHER

Anxiety and Depression Scale (HAD)

To screen for anxious and depressive symptoms

Intervention Type OTHER

pain scale

Measurement of pain intensity

Intervention Type PROCEDURE

hypnosis consultation

5 hypnosis consultation

Intervention Type PROCEDURE

Maintenance

Qualitative assessment

Intervention Type PROCEDURE

Data collection

Age, sex, socio-professional category, level of education, comorbidities, date of diagnosis of chronic peripheral neuropathic pain, distance between home and hospital.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennie SOURZAC

Role: PRINCIPAL_INVESTIGATOR

Université Hospital, Bordeaux

Locations

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Université Hospital, Bordeaux

Pessac, Pessac, France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2022/34

Identifier Type: -

Identifier Source: org_study_id

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