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

Primary Purpose

Peripheral Neuropathy, Pain

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Clinical examination
Anxiety and Depression Scale (HAD)
pain scale
hypnosis consultation
Maintenance
Data collection
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peripheral Neuropathy focused on measuring peripheral chronic neuropathic pain, hypnosis, teleconsultations, feasability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Université Hospital, BordeauxRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

combination of face-to-face and teleconsultation hypnosis consultation

face-to-face hypnosis consultation

Arm Description

The first and the last hypnosis sessions in face-to-face, and the other 3 intermediate sessions being conducted by teleconsultation.

5 face-to-face hypnosis sessions

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
Numerical Pain Assessme
Mean difference in pain score, minimum value is 0 and maximum value is 10
Hospital Anxiety and Depression scale (HAD)
Mean difference in the anxiety and depression score, minimum value is 0 and maximum value is 42
Learning self-hypnosis
Evaluate the frequency of the use of self-hypnosis throughout the treatment.
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).

Full Information

First Posted
October 27, 2022
Last Updated
October 5, 2023
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT05623449
Brief Title
Teleconsultations Hypnosis Sessions for Patients With Peripheral Chronic Neuropathic Pain
Acronym
HYPTEC
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy, Pain
Keywords
peripheral chronic neuropathic pain, hypnosis, teleconsultations, feasability

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
combination of face-to-face and teleconsultation hypnosis consultation
Arm Type
Experimental
Arm Description
The first and the last hypnosis sessions in face-to-face, and the other 3 intermediate sessions being conducted by teleconsultation.
Arm Title
face-to-face hypnosis consultation
Arm Type
Active Comparator
Arm Description
5 face-to-face hypnosis sessions
Intervention Type
Other
Intervention Name(s)
Clinical examination
Intervention Description
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
Intervention Name(s)
Anxiety and Depression Scale (HAD)
Intervention Description
To screen for anxious and depressive symptoms
Intervention Type
Procedure
Intervention Name(s)
pain scale
Intervention Description
Measurement of pain intensity
Intervention Type
Procedure
Intervention Name(s)
hypnosis consultation
Intervention Description
5 hypnosis consultation
Intervention Type
Procedure
Intervention Name(s)
Maintenance
Intervention Description
Qualitative assessment
Intervention Type
Other
Intervention Name(s)
Data collection
Intervention Description
Age, sex, socio-professional category, level of education, comorbidities, date of diagnosis of chronic peripheral neuropathic pain, distance between home and hospital.
Primary Outcome Measure Information:
Title
5 hypnosis consultations (in face-to-face and by teleconsultation).
Description
The rate (%) of included patients who have completed the 5 hypnosis consultations (in face-to-face and by teleconsultation).
Time Frame
Month 8
Secondary Outcome Measure Information:
Title
Achievement/Acceptability
Description
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).
Time Frame
Month 8
Title
Numerical Pain Assessme
Description
Mean difference in pain score, minimum value is 0 and maximum value is 10
Time Frame
Day 0, month 1, month 2, month 3 month 4 and montth 7
Title
Hospital Anxiety and Depression scale (HAD)
Description
Mean difference in the anxiety and depression score, minimum value is 0 and maximum value is 42
Time Frame
Day 0, month 4 and month 7
Title
Learning self-hypnosis
Description
Evaluate the frequency of the use of self-hypnosis throughout the treatment.
Time Frame
Day 0, month 1, month 2, month 3 month 4 and montth 7
Title
Ssatisfaction scale
Description
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).
Time Frame
Month 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennie SOURZAC
Phone
0677551606
Email
jennie.sourzac@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennie SOURZAC
Organizational Affiliation
Université Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Université Hospital, Bordeaux
City
Pessac
ZIP/Postal Code
33600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennie SOURZAC

12. IPD Sharing Statement

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Teleconsultations Hypnosis Sessions for Patients With Peripheral Chronic Neuropathic Pain

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