Skip to main content
Clinical Trials/NCT02947919
NCT02947919
Withdrawn
Not Applicable

Impacto de la música en el estrés Preoperatorio en niños Sometidos a cirugía General

Pontificia Universidad Catolica de Chile1 site in 1 countryJuly 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress, Physiological
Sponsor
Pontificia Universidad Catolica de Chile
Locations
1
Primary Endpoint
Change in salivary cortisol concentration
Status
Withdrawn
Last Updated
7 years ago

Overview

Brief Summary

Preoperative anxiety and stress are present in up to 60% of pediatric patients undergoing surgery, having a great physiological and emotional impact on children in both the short and long term. There are many reports on the use of music therapy in the perioperative period as a complementary technique in the preoperative stress and anxiety management. However, there are no assessments of the effect of this intervention on the physiological variables, such as salivary cortisol.

Detailed Description

60 patients aged 5-7 years, ASA (American Society of Anesthesiologists) status I-II, scheduled for general surgery at the Hospital of the Catholic University and associate institutions, will be considered for inclusion. 30 will receive music as intervention and 30 will received usual treatment. Salivary cortisol samples will be obtained preoperatively, in the surgical ward (OR), and in the post-anesthesia care unit (PACU). Secondary outcomes will be M-YPAS (Yale Preoperative Anxiety Scale) for children, and STAI (State-Trait Anxiety Inventory) for parents scales.

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
August 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Elective surgery
  • Parents' consent

Exclusion Criteria

  • History of endocrine diseases (hypothyroidism, treatment with growth hormone, severely obese)
  • Taking glucocorticoid inhalers or oral corticosteroids
  • Children with severe hearing problems
  • Patients requiring emergency surgery
  • Refusal to participate in the study

Outcomes

Primary Outcomes

Change in salivary cortisol concentration

Time Frame: Before intervention (preoperative unit) and at an average of 30 minutes after surgery (at the post-anesthesia care unit)

Secondary Outcomes

  • M-YPAS(Before intervention (preoperative unit) and at an average of 30 minutes after surgery (at the post-anesthesia care unit))

Study Sites (1)

Loading locations...

Similar Trials