Peripheral NeuropathyHYPTECNCT05623449
Teleconsultations Hypnosis Sessions for Patients With Peripheral Chronic Neuropathic Pain
A study testing Clinical examination, Anxiety and Depression Scale (HAD) and pain scale in people with Peripheral Neuropathy and Pain, run by University Hospital, Bordeaux at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Neuropathy, Pain
- What is being tested?
- Clinical examination, Anxiety and Depression Scale (HAD) and pain scale
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 23 Feb 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monocentric Pilot Study of the Feasibility of Teleconsultations Hypnosis Sessions Led by a Nurse for Patients With Peripheral Chronic Neuropathic Pain - HYPTEC
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.
Read the 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.
- Conditions
- Peripheral Neuropathy, Pain
- Being tested
- Clinical examination, Anxiety and Depression Scale (HAD), pain scale, hypnosis consultation, Maintenance
- Keywords
- peripheral chronic neuropathic pain, hypnosis, teleconsultations, feasability
- Medical subject headings
- Peripheral Nervous System Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examinationOther
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)Other
To screen for anxious and depressive symptoms
pain scaleProcedure or surgery
Measurement of pain intensity
hypnosis consultationProcedure or surgery
5 hypnosis consultation
MaintenanceProcedure or surgery
Qualitative assessment
Data collectionOther
Age, sex, socio-professional category, level of education, comorbidities, date of diagnosis of chronic peripheral neuropathic pain, distance between home and hospital.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Clinical examination; Other: Anxiety and Depression Scale (HAD); Procedure: pain scale; Procedure: hypnosis consultation; Procedure: Maintenance; Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Month 8
Secondary outcomes (5)
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).
Measured: Month 8
Numerical Pain Assessme
Mean difference in pain score, minimum value is 0 and maximum value is 10
Measured: Day 0, month 1, month 2, month 3 month 4 and montth 7
Hospital Anxiety and Depression scale (HAD)
Mean difference in the anxiety and depression score, minimum value is 0 and maximum value is 42
Measured: Day 0, month 4 and month 7
Learning self-hypnosis
Evaluate the frequency of the use of self-hypnosis throughout the treatment.
Measured: Day 0, month 1, month 2, month 3 month 4 and montth 7
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).
Measured: Month 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start23 Feb 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennie SOURZAC, Principal investigator, Université Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623449
- Sponsor's protocol ID
- CHUBX 2022/34
- Other IDs
- 2022-A02022-41
- Acronym
- HYPTEC
- Status last verified
- Nov 2024
- First submitted
- 27 Oct 2022
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Pilot Study of the Feasibility of Teleconsultations Hypnosis Sessions Led by a Nurse for Patients With Peripheral Chronic Neuropathic Pain - HYPTEC
- ClinicalTrials.gov ID
- NCT05623449
- Acronym / sponsor ID
- HYPTEC / CHUBX 2022/34
- Conditions
- Peripheral Neuropathy, Pain
- Keywords
- peripheral chronic neuropathic pain, hypnosis, teleconsultations, feasability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 21 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combination of face-to-face and teleconsultation hypnosis consultation | Experimental | Other: Clinical examination, Other: Anxiety and Depression Scale (HAD), Procedure: pain scale, Procedure: hypnosis consultation, Procedure: Maintenance, Other: Data collectionThe first and the last hypnosis sessions in face-to-face, and the other 3 intermediate sessions being conducted by teleconsultation. |
| face-to-face hypnosis consultation | Active comparator | Other: Clinical examination, Other: Anxiety and Depression Scale (HAD), Procedure: pain scale, Procedure: hypnosis consultation, Procedure: Maintenance, Other: Data collection5 face-to-face hypnosis sessions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical examinationCurrent 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). | Other | combination of face-to-face and teleconsultation hypnosis consultation, face-to-face hypnosis consultation |
| Anxiety and Depression Scale (HAD)To screen for anxious and depressive symptoms | Other | combination of face-to-face and teleconsultation hypnosis consultation, face-to-face hypnosis consultation |
| pain scaleMeasurement of pain intensity | Procedure or surgery | combination of face-to-face and teleconsultation hypnosis consultation, face-to-face hypnosis consultation |
| hypnosis consultation5 hypnosis consultation | Procedure or surgery | combination of face-to-face and teleconsultation hypnosis consultation, face-to-face hypnosis consultation |
| MaintenanceQualitative assessment | Procedure or surgery | combination of face-to-face and teleconsultation hypnosis consultation, face-to-face hypnosis consultation |
| Data collectionAge, sex, socio-professional category, level of education, comorbidities, date of diagnosis of chronic peripheral neuropathic pain, distance between home and hospital. | Other | combination of face-to-face and teleconsultation hypnosis consultation, face-to-face hypnosis consultation |
Primary outcome
5 hypnosis consultations (in face-to-face and by teleconsultation).
Time frame: Month 8
The rate (%) of included patients who have completed the 5 hypnosis consultations (in face-to-face and by teleconsultation).
5 secondary outcomes
Achievement/Acceptability
Time frame: Month 8
Numerical Pain Assessme
Time frame: Day 0, month 1, month 2, month 3 month 4 and montth 7
Hospital Anxiety and Depression scale (HAD)
Time frame: Day 0, month 4 and month 7
Learning self-hypnosis
Time frame: Day 0, month 1, month 2, month 3 month 4 and montth 7
Ssatisfaction scale
Time frame: Month 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennie SOURZAC principal investigator
Université Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical examination, Anxiety and Depression Scale (HAD) and pain scale in people with Peripheral Neuropathy and Pain, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5 hypnosis consultations (in face-to-face and by teleconsultation). (time frame: Month 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.