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Effectiveness of Energy Resonance by Skin Stimulation in the Management of Anxious Patients Who Require Scheduled Orthopaedic Surgery (ERESCAO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03773198
Recruitment Status : Recruiting
First Posted : December 12, 2018
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:

The need for a surgical procedure may cause a patient to experience reactive anxiety. This reaction is appropriate if it is of low to moderate intensity. On the other hand, various studies have shown that postoperative awakening is more complicated if the patient experiences major preoperative anxiety. Thus, reducing anxiety could be a tool for preventing chronic pain.

For several years now, the investigator's facility has been implementing Energy Resonance through Cutaneous Stimulation (ERCS), a method based on "listening" to the body's vibrations through the fingers on points based on the mapping of meridians in Chinese medicine.

ERCS practitioners have noted the benefits of this method, particularly in soothing patients. It therefore seems necessary to detect and manage this anxiety beforehand and ERCS seems appropriate in this situation.


Condition or disease Intervention/treatment Phase
Patient Requiring Scheduled Conventional Orthopedic Surgical Intervention of the Upper or Lower Limb Other: Energy Resonance through Cutaneous Stimulation Other: questionnaires Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effectiveness of Energy Resonance by Skin Stimulation in the Management of Anxious Patients Who Require Scheduled Orthopaedic Surgery
Actual Study Start Date : April 5, 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: ERCS Group Other: Energy Resonance through Cutaneous Stimulation
The ERCS method involves "listening" to the body by applying fingers to the acupuncture skin points, developed according to the energy imbalance caused by illness, pain and emotional disorders.

Other: questionnaires
Measurement of anxiety-trait and state-anxiety (Spielberger), pain ( numerical scale) and satisfaction (numerical satisfaction scale)

Placebo Comparator: Control Group Other: questionnaires
Measurement of anxiety-trait and state-anxiety (Spielberger), pain ( numerical scale) and satisfaction (numerical satisfaction scale)




Primary Outcome Measures :
  1. anxiety-state [ Time Frame: During the surgical procedure ]
    Evolution of the patient's anxiety, between the entry and exit of the surgical department measured by the Spielberger state anxiety inventory, which is intended to evaluate an emotional reaction at a given time represented here by the operating room.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient who has given oral consent
  • Adult patient requiring scheduled conventional orthopedic surgery of the upper limb (wrist, elbow, shoulder) or lower limb (ankle, foot, knee, hip)

Exclusion Criteria:

  • Patient not affiliated to a national health insurance system,
  • Patient subject to a legal protection measure (curatorship, guardianship)
  • Patient subject to a justice protection measure
  • Pregnant, parturient or breastfeeding woman
  • Patient unable to give consent
  • Minor
  • Patient with a pace maker
  • Patient with cognitive problems: Alzheimer's, senile dementia
  • Patient who has already received ERCS as part of surgery
  • Patient who does not speak or understand French
  • Patient with psychiatric disorders: major depression, bipolar disorder, addictive disorders, psychotic disorders (psychosis, schizophrenia, acute delirium)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03773198


Contacts
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Contact: Isabelle DAUVERGNE +33 385818490 isabelle.dauvergne@ch-paray.fr

Locations
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France
Chu Dijon Bourogne Recruiting
Dijon, France, 21000
Contact: Isabelle DAUVERGNE    +33 385818490    isabelle.dauvergne@ch-paray.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03773198    
Other Study ID Numbers: DAUVERGNE APPARA 2017
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No