Demonstrate the Value of Using Hypnosis in Chimiotherapy- Induced Chronic Neuropathies

NCT ID: NCT03156595

Last Updated: 2021-10-19

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-04

Study Completion Date

2021-11-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Chimiotherapy produces neuropathies injuries to 30% to 70% cases. A third of those patients keeps suffering from this side effects disabilities and their quality of life is seriously affected.

Hypnosis, as a non-invasive tool without physical side effects, might be used to relieve them.

the purpose of this trial based on our own experience, is to demonstrate the value of using hypnosis and self-hypnosis in chimiotherapy- induced chronic neuropathies.

The aim will be to sustainably improve the quality of life by expanding self-management of pain and motor function side effect.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chemotherapy-induced Neuropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nurse interview

Personal interview with nurses to evaluate the relief of neuropathic pains with the reference treatment. (If necessary send to the medical team ) It's a listening time around neuropathic pain which altered the quality of life.

Group Type PLACEBO_COMPARATOR

Nurse interview

Intervention Type BEHAVIORAL

Personal interview with nurses to evaluate the relief of neuropathic pains with the reference treatment. (If necessary send to the medical team ) It's a listening time around neuropathic pain which altered the quality of life.

Hypnosis session

Hypnosis sessions with nurses or psychologists, with deepening sessions to facilitate self-hypnosis learning.

Group Type EXPERIMENTAL

Hypnosis sessions

Intervention Type BEHAVIORAL

Hypnosis sessions with a nurse or psychologist, with deepening sessions to facilitate self-hypnosis learning.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nurse interview

Personal interview with nurses to evaluate the relief of neuropathic pains with the reference treatment. (If necessary send to the medical team ) It's a listening time around neuropathic pain which altered the quality of life.

Intervention Type BEHAVIORAL

Hypnosis sessions

Hypnosis sessions with a nurse or psychologist, with deepening sessions to facilitate self-hypnosis learning.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Listening time

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Minimum age :18 years
* Chemiotherapy- induced chronic neuropathies for at least 2 months with a DN4 score \>4
* Failure of classic treatment used to relief neuropathic
* Having stopped chemotherapy treatment and being in complete or partial response or in tumoral stability
* Without any planed chemiotherapy during the study
* Having signed a written informed consent.
* French efficient understanding
* With health insurance coverage
* availability during all the study
* With efficient contraception for women of childbearing age

Exclusion Criteria

* No participation to another study at the same time
* Suffering from neuropathy before having chemotherapy
* Other disease that may cause neuropathy
* deafness
* Any medicine that could cause neuropathy
* Neurological or psychiatrical disease past or present
* Mental retardation
* Allergy to EMG's electrodes
* Unable to consent, under tutelage or curatorship or judiciary safeguard
* Pregnant or nursing woman
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Caroline MAURER, Nurse

Role: STUDY_CHAIR

Strasbourg's University Hospitals

Raoul HERBRECHT, MD

Role: PRINCIPAL_INVESTIGATOR

Strasbourg's University Hospitals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Strasbourg Hospital

Strabsourg, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Anne Laudamy

Role: CONTACT

+33 3 88 11 66 88

anatta Razafimanantsoa

Role: CONTACT

+ 33 3 88 11 54 14

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Raoul HERBRECHT, MD

Role: primary

Caroline MAURER, Nurse

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PHRIP 2015 - HUS n°6395

Identifier Type: -

Identifier Source: org_study_id