Personalized Quantum Sonotherapy in Regional Anesthesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2017-03-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Pain, Postoperative Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Personalized quantum sonotherapy

Intervention Type 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.

Control group

Patients will wear headphones but without playing the personalized quantum sonotherapy

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type PROCEDURE

Headphones will be place in patients without playing quantum sonotherapy

Interventions

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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.

Intervention Type PROCEDURE

Placebo

Headphones will be place in patients without playing quantum sonotherapy

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes