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Personalized Quantum Sonotherapy in Regional Anesthesia

Primary Purpose

Pain, Postoperative, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Personalized quantum sonotherapy
Placebo
Sponsored by
CES University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Personalized quantum sonotherapy, Regional anesthesia, Peripheral nerve block

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Instituto Colombiano del Dolor

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Personal quantum sonotherapy group

Control group

Arm Description

Patients who will listen through MP3 devices the personalized quantum sonotherapy previously created through a especialized software, before the application of regional anesthesia.

Patients will wear headphones but without playing the personalized quantum sonotherapy

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 25, 2018
Last Updated
April 18, 2018
Sponsor
CES University
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1. Study Identification

Unique Protocol Identification Number
NCT03512587
Brief Title
Personalized Quantum Sonotherapy in Regional Anesthesia
Official Title
Personalized Quantum Sonotherapy in Regional Anesthesia Peripheral Nerve Block: Randomized and Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
March 31, 2017 (Actual)
Study Completion Date
March 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CES University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Anxiety
Keywords
Personalized quantum sonotherapy, Regional anesthesia, Peripheral nerve block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Personal quantum sonotherapy group
Arm Type
Experimental
Arm Description
Patients who will listen through MP3 devices the personalized quantum sonotherapy previously created through a especialized software, before the application of regional anesthesia.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Patients will wear headphones but without playing the personalized quantum sonotherapy
Intervention Type
Procedure
Intervention Name(s)
Personalized quantum sonotherapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Placebo
Intervention Description
Headphones will be place in patients without playing quantum sonotherapy
Primary Outcome Measure Information:
Title
Pain
Description
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.
Time Frame
48 hours (From the moment before surgery when the sonotherapy is apply until 48 hours after surgery)
Title
Anxiety
Description
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.
Time Frame
48 hours (From the moment before surgery when the sonotherapy is apply until 48 hours after surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mara P Gonzalez, MD
Organizational Affiliation
University CES
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Colombiano del Dolor
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
0000
Country
Colombia

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Personalized Quantum Sonotherapy in Regional Anesthesia

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