Non-pharmacological Treatments for Non-malignant and Malignant Pain

NCT ID: NCT04217681

Last Updated: 2020-02-10

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-08

Study Completion Date

2021-01-30

Brief Summary

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Chronic pain concerns one in four adults in Belgium. Because of the psychological and social repercussions, a biopsychosocial approach is necessary in order to improve the quality of life of people suffering from chronic pain. Non-pharmacological techniques such as hypnosis, self-care learning and music-therapy are gaining more and more interest in the scientific field. Indeed, several studies have shown a reduction in psychological distress and an improvement in global quality of life after having learned self-hypnosis/self-care. Furthermore, other studies focusing on music as a treatment for chronic pain highlight an analgesic effect of music over pain and a reduction of common comorbidities. Nevertheless, only few studies aim at comparing these techniques to each other. The aim of our study would be to compare a 7 months learning program of self-hypnosis/self-care, music-therapy/self-care, motivation to learn self-hypnosis/self-care in order to highlight the most efficient treatment for chronic pain. Furthermore, we will include another type of chronic pain i.e. cancer pain to understand if self-hypnosis/self-care's impact is different in the other type of chronic pain.

Detailed Description

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Conditions

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Comparison of Treatment for Chronic Non-malignant and Malignant Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Each patients will have a medical consultation and will have to fill-in questionnaires (T0). After, patients will have to participate in a 5-session psycho-education programme. After, the care staff will have a multidisciplinary discussion and will randomize the participants to different treatment groups : self-hypnosis/self-care and music/self-care. Another group will be included but will not be randomized because it includes patients who demand to learn self-hypnosis/self-care (non-malignant and malignant pain). After, participants will receive a 7 months (2 hours session a month) learning program of self-hypnosis/self-care animated by a therapist specialized in hypnosis or music/self-care (identical procedure but the hypnosis is replaced by music) at the end if which they will complete the same questionnaire (T2). A follow-up at 6 (T3) and 12 (T4) months will also be conducted to account for any long term effect.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Self-hypnosis/self-care group

It is a 7-months 2 hours-session (1 session per month) of self-hypnosis/self-care learning. Participants are given strategies to learn self-care (knowing their needs, self-respect, communication etc.), each strategy is discussed for participant to understand them and thus apply them correctly in daily life. An hypnosis exercise is conducted at the end of each session. A CD with the audiotaped hypnosis exercise is given to each patient so that they can practice also every day.

Group Type EXPERIMENTAL

Self-hypnosis/self-care

Intervention Type BEHAVIORAL

It is a 7-months 2 hours-session (1 session per month) of self-hypnosis/self-care learning. Participants are given strategies to learn self-care (knowing their needs, self-respect, communication etc.), each strategy is discussed for participant to understand them and thus apply them correctly in daily life. An hypnosis exercise is conducted at the end of each session. A CD with the audiotaped hypnosis exercise is given to each patient so that they can practice also every day.

Music/self-care

It is a 7-months 2 hours-session (1 session per month) of music/self-care learning. Participants are given strategies to learn self-care (knowing their needs, self-respect, communication etc.), each strategy is discussed for participant to understand them and thus apply them correctly in daily life. At the end of each session, patients are invited to listen to a relaxing melody of 15 minutes. This melody was composed by a professional musico-therapist. A CD with the audiotaped melody is given to each patient so that they can practice also every day.

Group Type EXPERIMENTAL

Music/self-care

Intervention Type BEHAVIORAL

It is a 7-months 2 hours-session (1 session per month) of music/self-care learning. Participants are given strategies to learn self-care (knowing their needs, self-respect, communication etc.), each strategy is discussed for participant to understand them and thus apply them correctly in daily life. At the end of each session, patients are invited to listen to a relaxing melody of 15 minutes. This melody was composed by a professional musico-therapist. A CD with the audiotaped melody is given to each patient so that they can practice also every day.

Self-hypnosis/self-care motivation

It is a 7-months 2 hours-session (1 session per month) of self-hypnosis/self-care learning. Participants are given strategies to learn self-care (knowing their needs, self-respect, communication etc.), each strategy is discussed for participant to understand them and thus apply them correctly in daily life. An hypnosis exercise is conducted at the end of each session. A CD with the audiotaped hypnosis exercise is given to each patient so that they can practice also every day.

Group Type EXPERIMENTAL

Self-hypnosis/self-care motivation

Intervention Type BEHAVIORAL

It is a 7-months 2 hours-session (1 session per month) of self-hypnosis/self-care learning. Participants are given strategies to learn self-care (knowing their needs, self-respect, communication etc.), each strategy is discussed for participant to understand them and thus apply them correctly in daily life. An hypnosis exercise is conducted at the end of each session. A CD with the audiotaped hypnosis exercise is given to each patient so that they can practice also every day.

Self-hypnosis/self-care malignant pain

It is a 7-months 2 hours-session (1 session per month) of self-hypnosis/self-care learning. Participants are given strategies to learn self-care (knowing their needs, self-respect, communication etc.), each strategy is discussed for participant to understand them and thus apply them correctly in daily life. An hypnosis exercise is conducted at the end of each session. A CD with the audiotaped hypnosis exercise is given to each patient so that they can practice also every day.

Group Type EXPERIMENTAL

Self-hypnosis/self-care malignant pain

Intervention Type BEHAVIORAL

It is a 7-months 2 hours-session (1 session per month) of self-hypnosis/self-care learning. Participants are given strategies to learn self-care (knowing their needs, self-respect, communication etc.), each strategy is discussed for participant to understand them and thus apply them correctly in daily life. An hypnosis exercise is conducted at the end of each session. A CD with the audiotaped hypnosis exercise is given to each patient so that they can practice also every day.

Interventions

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Self-hypnosis/self-care

It is a 7-months 2 hours-session (1 session per month) of self-hypnosis/self-care learning. Participants are given strategies to learn self-care (knowing their needs, self-respect, communication etc.), each strategy is discussed for participant to understand them and thus apply them correctly in daily life. An hypnosis exercise is conducted at the end of each session. A CD with the audiotaped hypnosis exercise is given to each patient so that they can practice also every day.

Intervention Type BEHAVIORAL

Music/self-care

It is a 7-months 2 hours-session (1 session per month) of music/self-care learning. Participants are given strategies to learn self-care (knowing their needs, self-respect, communication etc.), each strategy is discussed for participant to understand them and thus apply them correctly in daily life. At the end of each session, patients are invited to listen to a relaxing melody of 15 minutes. This melody was composed by a professional musico-therapist. A CD with the audiotaped melody is given to each patient so that they can practice also every day.

Intervention Type BEHAVIORAL

Self-hypnosis/self-care motivation

It is a 7-months 2 hours-session (1 session per month) of self-hypnosis/self-care learning. Participants are given strategies to learn self-care (knowing their needs, self-respect, communication etc.), each strategy is discussed for participant to understand them and thus apply them correctly in daily life. An hypnosis exercise is conducted at the end of each session. A CD with the audiotaped hypnosis exercise is given to each patient so that they can practice also every day.

Intervention Type BEHAVIORAL

Self-hypnosis/self-care malignant pain

It is a 7-months 2 hours-session (1 session per month) of self-hypnosis/self-care learning. Participants are given strategies to learn self-care (knowing their needs, self-respect, communication etc.), each strategy is discussed for participant to understand them and thus apply them correctly in daily life. An hypnosis exercise is conducted at the end of each session. A CD with the audiotaped hypnosis exercise is given to each patient so that they can practice also every day.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Major
* Fluency in French
* Chronic pain diagnosis (malignant and non-malignant)

Exclusion Criteria

* Neurologic disorder
* Psychiatric disorder
* Drug addiction
* Alcoholism
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Audrey Vanhaudenhuyse

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital University of Liège

Liège, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Audrey Vanhaudenhuyse, PhD

Role: CONTACT

+32 4 366 84 82

Aminata Bicego, PhD Student

Role: CONTACT

+3243663499

Facility Contacts

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Audrey Vanhaudenhuyse, PhD

Role: primary

+3243668482

Aminata Bicego, PhD Student

Role: backup

+3243663499

Other Identifiers

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2015/85-B

Identifier Type: -

Identifier Source: org_study_id

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