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NCT Number: NCT03512587

Personalized Quantum Sonotherapy in Regional Anesthesia

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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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto Colombiano del Dolor

Medellín, Antioquia, 0000, Colombia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Placebo

Procedure

Headphones will be place in patients without playing quantum sonotherapy

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

CES University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 1, 2018
Registry last updated
May 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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