Efficacy of Ericksonian Hypnosis in the Management of Chronic Pain Related to Parkinson's Disease (DOLHYP-PARK-1)

December 4, 2025 updated by: University Hospital, Lille
This study evaluates the efficacity of Erickson hypnosis in the treatment of chronic pain in patients with Parkinson's disease. Half of participants will follow a 2-month Erickson hypnosis protocole, while the other half will benefit from the usual care.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A large proportion of patients with Parkinson's disease suffer of chronic pain directly related to the disease. The management of painful symptoms is difficult and currently, there is no commonly admitted guidelines.

Several studies have shown the efficacy of Erickson hypnosis to reduce the perception of chronic pain in different conditions. This efficacy has never been tested in Parkinson's disease.

The objective of this study is to assess the efficacy of Erickson hypnosis protocol, compared to usual care, for the management of Parkinson's disease-related chronic pain.

The study team assume that Erickson hypnosis will be more efficient than usual care to reduce perceived chronic pain. They also assume that regular practice of autohypnosis will contribute to long-term efficacy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Caen, France
        • CHU côte de Nacre
      • Lille, France, 59800
        • Hopital Roger Salengro, CHRU de Lille
      • Rouen, France
        • Hopital Charles Nicolle Chu Rouen
      • Toulouse, France, 31300
        • Hopital Purpan Chu Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men or women
  • 18 to 80 years old
  • idiopathic Parkinson's disease
  • without neurological co-morbidity
  • Suffering from chronic pain (for at least 3 months), related to Parkinson's disease
  • Having a pain intensity of at least 30 mm on the VAS (average intensity over the previous week) for Parkinson's disease-related pain
  • antiparkinsonian, analgesic and psychotropic treatments stable for 1-month
  • having a health insurance
  • signed informed consent form

Exclusion Criteria:

  • Patient with a neurological condition other than Parkinson's disease or with an atypical Parkinson's syndrome
  • Early untreated patient
  • Patient with acute intercurrent pain
  • Patient whose pain is mainly attributable to another pathology (rheumatoid arthritis, spondyloarthritis ankylosing, diabetic neuropathy, cancer, etc.)
  • Patient with cognitive impairment objectified by a score at the Montreal Cognitive Assessment (MoCA) <24
  • Patient with hallucinations and/or psychosis (MDS-UPDRS 1.2> 1)
  • Patient with a apathy (MDS-UPDRS 1.5> 1)
  • Patient with disabling dyskinesia (MDS-UPDRS) 4.1 AND 4.2> 1)
  • Patient under the protection of adults
  • Pregnant or lactating woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Erickson hypnosis
5 sessions of Erickson hypnosis (1 session per week), associated with autohypnosis at home in-between sessions.
Behavioral: Erickson hypnosis
Erickson hypnosis sessions performed by an experienced hypnotherapist, according to a pre-established protocol : 5 sessions (1 per week). Between each session : exercise of auto-hypnosis by the patient himself, at home
No Intervention: Usual care
Usual management of pain symptoms

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of the intensity of pain perception
Time Frame: At baseline and 2 months after
Measure of the intensity of pain perception by VAS at the baseline visit and at the post-treatment visit (2 months later). The difference between both values will allow to calculate a variation index.
At baseline and 2 months after

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of the score at the Brief Pain Inventory
Time Frame: At baseline and 2 months after
Completion of the Brief Pain Inventory at the baseline visit and at the post-treatment visit (2 months later). The difference between both scores will allow to calculate a variation index.
At baseline and 2 months after
Change of the score at the McGill Pain Questionnaire
Time Frame: At baseline and 2 months after
Completion of the McGill Pain Questionnaire at the baseline visit and at the post-treatment visit (2 months later). The difference between both scores will allow to calculate a variation index.
At baseline and 2 months after
Change of the score at the Beck Depression Inventory
Time Frame: At baseline and 2 months after
Completion of the Beck Depression Inventory at the baseline visit and at the post-treatment visit (2 months later). The difference between both scores will allow to calculate a variation index.
At baseline and 2 months after
Change of the score at the Fatigue Severity Scale
Time Frame: At baseline and 2 months after
Completion of the Fatigue Severity Scale at the baseline visit and at the post-treatment visit (2 months later). The difference between both scores will allow to calculate a variation index.
At baseline and 2 months after
Change of the score at the Parkinson's Disease Questionnaire-8 (PDQ-8)
Time Frame: At baseline and 2 months after
Completion of the PDQ-8 at the baseline visit and at the post-treatment visit (2 months later). The difference between both scores will allow to calculate a variation index.
At baseline and 2 months after
Change of the score at the Scale for Outcomes at Parkinson's Disease (SCOPA-PS)
Time Frame: At baseline and 2 months after
Completion of the SCOPA-PS at the baseline visit and at the post-treatment visit (2 months later). The difference between both scores will allow to calculate a variation index.
At baseline and 2 months after
Change of the score at the Euroqol 5 dimensions 5 levels (EQ-5D-5L)
Time Frame: At baseline and 2 months after
Completion of the EQ-5D-5L at the baseline visit and at the post-treatment visit (2 months later). The difference between both scores will allow to calculate a variation index.
At baseline and 2 months after
Change in the dose of analgesic treatments
Time Frame: At baseline and 2 months after
Analgesic treatments will be recorded during the week preceding each visit and a mean dosage will be calculated during each period. The difference between both mean values will allow to calculate a variation index.
At baseline and 2 months after
Change in the dose of psychotropic medications
Time Frame: At baseline and 2 months after
Psychotropic medications will be recorded during the week preceding each visit and a mean dosage will be calculated during each period. The difference between both mean values will allow to calculate a variation index.
At baseline and 2 months after
Change of the score at MDS-UPDRS
Time Frame: At baseline and 2 months after
Completion of the MDS-UPDRS at the baseline visit and at the post-treatment visit (2 months later). The difference between both scores will allow to calculate a variation index.
At baseline and 2 months after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Lille

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
France Parkinson Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Luc Defebvre, MD,PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 8, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 16, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 16, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-51
  • 2019-A00539-48 (Other Identifier: ID-RCB number,ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings