Impact of Music in the Preoperative Stress of Children Undergoing General Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stress, Physiological, Stress, Psychological

Intervention / Treatment
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* Behavioral: Music


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective surgery ASA I-II 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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Music in the perioperative period | Behavioral: Music<br>* A previously defined list of songs will be administered by headphones to these patients with an MP3 device with headphones.<br>|
| No Intervention: Control<br>Usual treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in salivary cortisol concentration |  | Before intervention (preoperative unit) and at an average of 30 minutes after surgery (at the post-anesthesia care unit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| M-YPAS | M-YPAS (Yale Preoperative Anxiety Scale) | Before intervention (preoperative unit) and at an average of 30 minutes after surgery (at the post-anesthesia care unit) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perioperative Period, Music