Clinical trial NCT02947919: Impact of Music in the Preoperative Stress of Children Undergoing General Surgery
Official title: Impacto de la música en el estrés Preoperatorio en niños Sometidos a cirugía General
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stress, Physiological
Stress, Psychological
Keywords: Perioperative Period
Music
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2016-10-28
Enrollment: 0
Sex: ALL
Minimum age (years): 5
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in salivary cortisol concentration
timeFrame: Before intervention (preoperative unit) and at an average of 30 minutes after surgery (at the post-anesthesia care unit)
Secondary outcomes:
measure: M-YPAS
timeFrame: Before intervention (preoperative unit) and at an average of 30 minutes after surgery (at the post-anesthesia care unit)
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Clinical Hospital - Pontificia Universidad Católica de Chile
state: RM
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Rodrigo López, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McCann ME, Kain ZN. The management of preoperative anxiety in children: an update. Anesth Analg. 2001 Jul;93(1):98-105. doi: 10.1097/00000539-200107000-00022. No abstract available.
citation: Wennstrom B, Tornhage CJ, Nasic S, Hedelin H, Bergh I. The perioperative dialogue reduces postoperative stress in children undergoing day surgery as confirmed by salivary cortisol. Paediatr Anaesth. 2011 Oct;21(10):1058-65. doi: 10.1111/j.1460-9592.2011.03656.x. Epub 2011 Jul 20.