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

NCT03773198 | Completed Phase 3

• 1 other identifier: DAUVERGNE APPARA 2017
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

ERCS Group

EXPERIMENTAL

Other: Energy Resonance through Cutaneous Stimulation; Other: questionnaires

Control Group

PLACEBO COMPARATOR

Other: questionnaires

Interventions

Energy Resonance through Cutaneous Stimulation OTHER

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.

ERCS Group

questionnaires OTHER

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

Control Group; ERCS Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourogne

Dijon, 21000, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 12, 2018
• Study Start: April 5, 2019
• Primary Completion: May 12, 2023
• Study Completion: May 12, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-12

Locations

FR (1)