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

Phase 3

Completed

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

• Registration Number: NCT03773198
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-11
• Study First Posted: 2018-12-12
• Study Start: 2019-04-05
• Primary Completion: 2023-05-12
• Study Completion: 2023-05-12
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	questionnaires	-
ERCS Group	Energy Resonance through Cutaneous Stimulation	-
ERCS Group	questionnaires	-

Primary Outcome Measures

Name	Time	Method
anxiety-state	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.

Trial Locations

Locations (1)

Chu Dijon Bourogne; 🇫🇷 Dijon, France