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

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02947919

Enrollment

Registered

2016-10-28

Start date

2016-07-31

Completion date

2016-08-31

Last updated

2019-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress, Physiological, Stress, Psychological

Keywords

Perioperative Period, Music

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.

Interventions

BEHAVIORALMusic

A previously defined list of songs will be administered by headphones to these patients with an MP3 device with headphones.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

5 Years to 7 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	Time frame	Description
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)

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026