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

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.

Study Overview

• Status: Completed
• Conditions: Patient Requiring Scheduled Conventional Orthopedic Surgical Intervention of the Upper or Lower Limb
• Intervention / Treatment: Other: Energy Resonance through Cutaneous Stimulation; Other: questionnaires

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21000
    • Chu Dijon Bourogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control Group	Other: questionnaires; Measurement of anxiety-trait and state-anxiety (Spielberger), pain ( numerical scale) and satisfaction (numerical satisfaction scale)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anxiety-state	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.	During the surgical procedure

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2019
• Primary Completion (Actual): May 12, 2023
• Study Completion (Actual): May 12, 2023

Study Registration Dates

• First Submitted: December 4, 2018
• First Submitted That Met QC Criteria: December 11, 2018
• First Posted (Actual): December 12, 2018

Study Record Updates

• Last Update Posted (Actual): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: DAUVERGNE APPARA 2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No