search
Back to results

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

Primary Purpose

Alcohol Withdrawal Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Energetic Resonance by Cutaneous Stimulation
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alcohol Withdrawal Syndrome focused on measuring RESC, alcohol withdrawal syndrome

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hôpital croix rousse

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Energetic Resonance by Cutaneous Stimulation

Arm Description

Energetic Resonance by Cutaneous Stimulation session in addition to standard treatment for patients with withdrawal alcohol symptoms.

Outcomes

Primary Outcome Measures

Cushman Score measure after Energetic Resonance by Cutaneous Stimulation
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.

Secondary Outcome Measures

Anxiety depression scale
prescribed benzodiazepine amount
Analogic Visual Scale
Quality of life scale

Full Information

First Posted
May 19, 2014
Last Updated
August 22, 2017
Sponsor
Hospices Civils de Lyon
search

1. Study Identification

Unique Protocol Identification Number
NCT02146716
Brief Title
Assessment of Energetic Resonance by Cutaneous Stimulation on Withdrawal Alcohol Symptoms.
Acronym
RESC
Official Title
Assessment of Energetic Resonance by Cutaneous Stimulation on Withdrawal Alcohol Symptoms.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Withdrawal Syndrome
Keywords
RESC, alcohol withdrawal syndrome

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
Energetic Resonance by Cutaneous Stimulation
Arm Type
Experimental
Arm Description
Energetic Resonance by Cutaneous Stimulation session in addition to standard treatment for patients with withdrawal alcohol symptoms.
Intervention Type
Other
Intervention Name(s)
Energetic Resonance by Cutaneous Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cushman Score measure after Energetic Resonance by Cutaneous Stimulation
Description
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.
Time Frame
daily during one week
Secondary Outcome Measure Information:
Title
Anxiety depression scale
Time Frame
pre-screening, day 3 and day 7
Title
prescribed benzodiazepine amount
Time Frame
day 0 to day 7
Title
Analogic Visual Scale
Time Frame
before and after each Energetic Resonance by Cutaneous Stimulationsession at day 2, day 4 and day 6.
Title
Quality of life scale
Time Frame
day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claude Augustin-Normand, Dr
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital croix rousse
City
Lyon
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs