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

Not Applicable

Withdrawn

• Conditions: Stress, Physiological; Stress, Psychological
• Interventions: Behavioral: Music

• Registration Number: NCT02947919
• Lead Sponsor: Pontificia Universidad Catolica de Chile

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.

Study Timeline

• Study Start: 2016-07
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Study First Submitted: 2016-10-13
• Study First Submitted QC: 2016-10-26
• Study First Posted: 2016-10-28
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-24
• Last Update Posted: 2019-04-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Music	Music in the perioperative period

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
M-YPAS	Before intervention (preoperative unit) and at an average of 30 minutes after surgery (at the post-anesthesia care unit)	M-YPAS (Yale Preoperative Anxiety Scale)

Trial Locations

Locations (1)

Clinical Hospital - Pontificia Universidad Católica de Chile; 🇨🇱 Santiago, RM, Chile