Personalized Quantum Sonotherapy in Regional Anesthesia

Personalized Quantum Sonotherapy in Regional Anesthesia Peripheral Nerve Block: Randomized and Controlled Clinical Trial

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).

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Anxiety
• Intervention / Treatment: Procedure: Personalized quantum sonotherapy; Procedure: Placebo

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Antioquia
    • Medellin, Antioquia, Colombia, 0000
      • Instituto Colombiano del Dolor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Personal quantum sonotherapy group; Patients who will listen through MP3 devices the personalized quantum sonotherapy previously created through a especialized software, before the application of regional anesthesia.	Procedure: Personalized quantum sonotherapy; Quantum sonotherapy is an alternative non-pharmacological treatment that effects a molecular reorganization that occurs after the sound stimulus. The audible words and their waves have the ability to generate vibrations and stimulate the psycho-neuro-endocrine chain, independent of the semantic meaning of the words. It is an alternative therapy that uses non-musical sound waves.
PLACEBO_COMPARATOR: Control group; Patients will wear headphones but without playing the personalized quantum sonotherapy	Procedure: Placebo; Headphones will be place in patients without playing quantum sonotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	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.	48 hours (From the moment before surgery when the sonotherapy is apply until 48 hours after surgery)
Anxiety	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.	48 hours (From the moment before surgery when the sonotherapy is apply until 48 hours after surgery)

Collaborators and Investigators

• Sponsor: CES University
• Investigators: Principal Investigator: Mara P Gonzalez, MD, University CES

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2017
• Primary Completion (ACTUAL): March 31, 2017
• Study Completion (ACTUAL): March 31, 2017

Study Registration Dates

• First Submitted: March 25, 2018
• First Submitted That Met QC Criteria: April 18, 2018
• First Posted (ACTUAL): May 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 18, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Regional anesthesia; Peripheral nerve block; Personalized quantum sonotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 645

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No