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Personalized Quantum Sonotherapy in Regional Anesthesia

C

CES University

Status

Completed

Conditions

Pain, Postoperative
Anxiety

Treatments

Procedure: Personalized quantum sonotherapy
Procedure: Placebo

Study type

Interventional

Funder types

Other

Identifiers

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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