Personalized Quantum Sonotherapy in Regional Anesthesia

NCT03512587 | Completed DMC

• 1 other identifier: 645
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain, Postoperative; Anxiety

Keywords

Personalized quantum sonotherapy; Regional anesthesia; Peripheral nerve block

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

Personal quantum sonotherapy group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

Patients will wear headphones but without playing the personalized quantum sonotherapy

Procedure: Placebo

Interventions

Personalized quantum sonotherapy PROCEDURE

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.

Personal quantum sonotherapy group

Placebo PROCEDURE

Headphones will be place in patients without playing quantum sonotherapy

Control group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CES University: lead

Study Sites (1)

Instituto Colombiano del Dolor

Medellín, Antioquia, 0000, Colombia

Location

MeSH Terms

Conditions

Pain, Postoperative; Anxiety Disorders

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Study Officials

• Mara P Gonzalez, MD

  University CES

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: March 25, 2018
• First Posted: May 1, 2018
• Study Start: February 1, 2017
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: May 1, 2018

Record last verified: 2018-04

Locations

CO (1)