Teleconsultations Hypnosis Sessions for Patients with Peripheral Chronic Neuropathic Pain

NCT05623449 | Completed

• 1 other identifier: CHUBX 2022/34
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Neuropathy; Pain

Keywords

peripheral chronic neuropathic pain; hypnosis; teleconsultations; feasability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Achievement/Acceptability

  Month 8

• Numerical Pain Assessme

  Day 0, month 1, month 2, month 3 month 4 and montth 7

• Hospital Anxiety and Depression scale (HAD)

  Day 0, month 4 and month 7

• Learning self-hypnosis

  Day 0, month 1, month 2, month 3 month 4 and montth 7

• Ssatisfaction scale

  Month 7

Study Arms (2)

combination of face-to-face and teleconsultation hypnosis consultation

EXPERIMENTAL

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

Other: Clinical examination; Other: Anxiety and Depression Scale (HAD); Procedure: pain scale; Procedure: hypnosis consultation; Procedure: Maintenance; Other: Data collection

face-to-face hypnosis consultation

ACTIVE COMPARATOR

5 face-to-face hypnosis sessions

Other: Clinical examination; Other: Anxiety and Depression Scale (HAD); Procedure: pain scale; Procedure: hypnosis consultation; Procedure: Maintenance; Other: Data collection

Interventions

Clinical examination 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).

combination of face-to-face and teleconsultation hypnosis consultation; face-to-face hypnosis consultation

Anxiety and Depression Scale (HAD) OTHER

To screen for anxious and depressive symptoms

combination of face-to-face and teleconsultation hypnosis consultation; face-to-face hypnosis consultation

pain scale PROCEDURE

Measurement of pain intensity

combination of face-to-face and teleconsultation hypnosis consultation; face-to-face hypnosis consultation

hypnosis consultation PROCEDURE

5 hypnosis consultation

combination of face-to-face and teleconsultation hypnosis consultation; face-to-face hypnosis consultation

Maintenance PROCEDURE

Qualitative assessment

combination of face-to-face and teleconsultation hypnosis consultation; face-to-face hypnosis consultation

Data collection OTHER

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

combination of face-to-face and teleconsultation hypnosis consultation; face-to-face hypnosis consultation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Université Hospital, Bordeaux

Pessac, Pessac, 33600, France

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Pain

Interventions

Restraint, Physical; Maintenance; Data Collection

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques; Health Care Facilities Workforce and Services; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jennie SOURZAC

  Université Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 21, 2022
• Study Start: February 23, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-11

Locations

FR (1)