Assessment of Energetic Resonance by Cutaneous Stimulation on Withdrawal Alcohol Symptoms. (RESC)

August 22, 2017 updated by: Hospices Civils de Lyon
The purpose of RESC study is to assess the efficacy of Energetic Resonance by Cutaneous Stimulation on alcohol withdrawal symptoms measured by CUSHMAN score and in a second time to measure the benzodiazepine amount prescribed during the withdrawal time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • 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 Locations

  • France
      • Lyon, France
        • Hôpital Croix Rousse

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

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women between 18 and 80 years,
  • Patient with alcohol addiction,
  • Patient needing alcohol withdrawal in a hospital.
  • Patient with social Security,
  • Patient with inform consent signed.

Exclusion Criteria:

  • Pregnant women
  • Minor.
  • Major with guardianship.
  • People without sufficient information because of troubles of cognitive functions, or without sufficient knowledge of French language.

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
Intervention / Treatment
No Intervention: Control
Experimental: Energetic Resonance by Cutaneous Stimulation
Energetic Resonance by Cutaneous Stimulation session in addition to standard treatment for patients with withdrawal alcohol symptoms.
Other: Energetic Resonance by Cutaneous Stimulation
Energetic Resonance by Cutaneous Stimulation (RESC) is a non-invasive method based on energetic Chinese medicine principles and digital contact. RESC is characterized by echo phenomena between two stimulation points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cushman Score measure after Energetic Resonance by Cutaneous Stimulation
Time Frame: daily during one week
CUSHMAN score is represented by a scale with 7 variables collecting physiological modifications or behavioural manifestations related to adrenergic answer, neurovegetative signs, confusion, nervousness, perceptive or hallucinatory phenomena.
daily during one week

Secondary Outcome Measures

Outcome Measure
Time Frame
Anxiety depression scale
Time Frame: pre-screening, day 3 and day 7
pre-screening, day 3 and day 7
prescribed benzodiazepine amount
Time Frame: day 0 to day 7
day 0 to day 7
Analogic Visual Scale
Time Frame: before and after each Energetic Resonance by Cutaneous Stimulationsession at day 2, day 4 and day 6.
before and after each Energetic Resonance by Cutaneous Stimulationsession at day 2, day 4 and day 6.
Quality of life scale
Time Frame: day 0
day 0

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Claude Augustin-Normand, Dr, Hospices Civils de Lyon

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)

May 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

May 19, 2014

First Submitted That Met QC Criteria

May 21, 2014

First Posted (Estimate)

May 26, 2014

Study Record Updates

Last Update Posted (Actual)

August 23, 2017

Last Update Submitted That Met QC Criteria

August 22, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-840

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.

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