Teleconsultations Hypnosis Sessions for Patients With Peripheral Chronic Neuropathic Pain

Pain Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05623449
• Other study ID #: CHUBX 2022/34
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 23, 2023
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Pain
• Peripheral Nervous System Diseases
• Peripheral Neuropathy

Intervention

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).
• Anxiety and Depression Scale (HAD)
To screen for anxious and depressive symptoms

Procedure:
• pain scale
Measurement of pain intensity
• hypnosis consultation
5 hypnosis consultation
• 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.

Locations

Country	Name	City	State
France	Université Hospital, Bordeaux	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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