Personalized Quantum Sonotherapy in Regional Anesthesia

Not Applicable

Completed

• Conditions: Pain, Postoperative; Anxiety

• Registration Number: NCT03512587
• Lead Sponsor: CES University

Brief Summary

The objetive of the study is to evaluate the effect of personalized quantum sonotherapy on the level of anxiety and pain in outpatients schedule for orthopedic surgery under regional anesthesia in a second level center. The investigators believed that personalized quantum sonotherapy could reduce the levels of anxiety and pain before and after surgery evaluated through hemodynamic variables and scales for pain (analogous visual scale) and anxiety (STAI Spielberger anxious state questionnaire).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2017-03-31
• Study Completion: 2017-03-31
• Study First Submitted: 2018-03-25
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-18
• Last Update Submitted: 2018-04-18
• Study First Posted: 2018-05-01
• Last Update Posted: 2018-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients scheduled for elective orthopedic ambulatory surgery under regional anesthesia
• Age between 18 and 60 years.
• Patients with anesthetic risk ASA 1 and 2.
• Patients without contraindications for the administration of opioids and benzodiazepines.
• Patients living in the metropolitan area who have a telephone line and can be contacted by telephone within the first 48 hours through calls at 24 and 48 hours after surgery, made by the researchers at the number previously reported by the patient.
• Patients with an adequate level of understanding, who are able to communicate by telephone and understand a numerical scale.
• Patients who agree to participate in the work.

Exclusion Criteria

• Patients with auditory and cognitive problems.
• Patients requiring general anesthesia at some time during the intraoperative period.
• Patients with morbid obesity.
• Patients consuming anxiolytics in the last month.
• Patients whose start of surgery is after 45 minutes of the blockade.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain	48 hours (From the moment before surgery when the sonotherapy is apply until 48 hours after surgery)	To assess the effect of personalized quantum sonotherapy on the level of pain of patients taken to orthopedic surgery under regional anesthesia through pain score visual analoge score (VAS). VAS ranges from 0 to 10 being 0 no pain an 10 the worst pain ever felted. It would be measured before and after placing de sonotherapy, 24 and 48 hour after surgery.
Anxiety	48 hours (From the moment before surgery when the sonotherapy is apply until 48 hours after surgery)	To assess the effect of personalized quantum sonotherapy on the level of anxiety of patients taken to orthopedic surgery under regional anesthesia through anxiety score Questionnaire of anxious state STAI (Spielberger). STAI is a score to meausre anxiety, it has 20 questions each one with a possible value from 0 to 3 points. Total score is evaluated adding each score for each question, and it goes from 0 to 60 points, being 60 de higest score for anxiety. It would be measured before and after placing de sonotherapy, 24 and 48 hour after surgery.

Trial Locations

Locations (1)

Instituto Colombiano del Dolor; 🇨🇴 Medellin, Antioquia, Colombia