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Clinical Trials/NCT03773198
NCT03773198CompletedPhase 3

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

Centre Hospitalier Universitaire Dijon2 sites in 1 country86 target enrollmentStarted: April 5, 2019Last updated:
Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
86
Locations
2
Primary Endpoint
anxiety-state

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • 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)

Outcomes

Primary Outcomes

anxiety-state

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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