Personalized Quantum Sonotherapy in Regional Anesthesia

• ClinicalTrials.gov Identifier: NCT03512587
• Recruitment Status: Completed
• First Posted: May 1, 2018
• Last Update Posted: May 1, 2018
• Sponsor: CES University
• Information provided by (Responsible Party): Ana Sofia Arango Gutierrez, CES University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Pain, Postoperative; Anxiety	Procedure: Personalized quantum sonotherapy; Procedure: Placebo	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Personalized Quantum Sonotherapy in Regional Anesthesia Peripheral Nerve Block: Randomized and Controlled Clinical Trial
• Actual Study Start Date: February 1, 2017
• Actual Primary Completion Date: March 31, 2017
• Actual Study Completion Date: March 31, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Pain [ Time Frame: 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.
2. Anxiety [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Colombia

Instituto Colombiano del Dolor

Medellin, Antioquia, Colombia, 0000

Sponsors and Collaborators

CES University

Investigators

• Principal Investigator: Mara P Gonzalez, MD; University CES

More Information

• Responsible Party: Ana Sofia Arango Gutierrez, Medical Doctor, CES University
• ClinicalTrials.gov Identifier: NCT03512587
• Other Study ID Numbers: 645
• First Posted: May 1, 2018
• Last Update Posted: May 1, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ana Sofia Arango Gutierrez, CES University:

Personalized quantum sonotherapy; Regional anesthesia; Peripheral nerve block

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations