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

Patient Requiring Scheduled Conventional Orthopedic Surgical Intervention of the Upper or Lower Limb Clinical Trial

— ERESCAO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03773198
• Other study ID #: DAUVERGNE APPARA 2017
• Status: Completed
• Phase: Phase 3
• Start date: April 5, 2019
• Est. completion date: May 12, 2023

Study information

• Verified date: December 2023
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: May 12, 2023
• Est. primary completion date: May 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Patient Requiring Scheduled Conventional Orthopedic Surgical Intervention of the Upper or Lower Limb

Intervention

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

Locations

Country	Name	City	State
France	Chu Dijon Bourogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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