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

NCT ID: NCT03773198

Last Updated: 2023-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-05
• Study Completion Date: 2023-05-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

ERCS Group

Group Type: EXPERIMENTAL

Energy Resonance through Cutaneous Stimulation

Intervention Type: 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.

questionnaires

Intervention Type: OTHER

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

Control Group

Group Type: PLACEBO_COMPARATOR

questionnaires

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

questionnaires

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

Intervention Type: OTHER

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Dijon Bourogne

Dijon, , France

Countries

France

Other Identifiers

DAUVERGNE APPARA 2017

Identifier Type: -

Identifier Source: org_study_id