Personalized Quantum Sonotherapy in Regional Anesthesia

CES University

Status: Completed

Conditions: Pain, Postoperative; Anxiety

Treatments: Procedure: Personalized quantum sonotherapy; Procedure: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03512587

645

Details and patient eligibility

About

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).

Enrollment: 80 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups, including a placebo group

Personal quantum sonotherapy group

Experimental group

Description:

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

Treatment:

Procedure: Personalized quantum sonotherapy

Control group

Placebo Comparator group

Description:

Patients will wear headphones but without playing the personalized quantum sonotherapy

Treatment:

Procedure: Placebo