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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-08-31

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.

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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.

Conditions

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Stress, Physiological Stress, Psychological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intervention

Music in the perioperative period

Group Type EXPERIMENTAL

Music

Intervention Type BEHAVIORAL

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

Control

Usual treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music

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

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

5 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes