Back to resultsImpact of Music in the Preoperative Stress of Children Undergoing General Surgery
Primary Purpose
Stress, Physiological, Stress, Psychological
Status
Withdrawn
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Music
Sponsored by
About this trial
This is an interventional prevention trial for Stress, Physiological focused on measuring Perioperative Period, Music
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
Sites / Locations
- Clinical Hospital - Pontificia Universidad Católica de Chile
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Music in the perioperative period
Usual treatment
Outcomes
Primary Outcome Measures
Change in salivary cortisol concentration
Secondary Outcome Measures
M-YPAS
M-YPAS (Yale Preoperative Anxiety Scale)
Full Information
NCT ID
NCT02947919
First Posted
October 13, 2016
Last Updated
April 24, 2019
Sponsor
Pontificia Universidad Catolica de Chile
1. Study Identification
Unique Protocol Identification Number
NCT02947919
Brief Title
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
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Problems with samples handling
Study Start Date
July 2016 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pontificia Universidad Catolica de Chile
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Physiological, Stress, Psychological
Keywords
Perioperative Period, Music
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Music in the perioperative period
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual treatment
Intervention Type
Behavioral
Intervention Name(s)
Music
Intervention Description
A previously defined list of songs will be administered by headphones to these patients with an MP3 device with headphones.
Primary Outcome Measure Information:
Title
Change in salivary cortisol concentration
Time Frame
Before intervention (preoperative unit) and at an average of 30 minutes after surgery (at the post-anesthesia care unit)
Secondary Outcome Measure Information:
Title
M-YPAS
Description
M-YPAS (Yale Preoperative Anxiety Scale)
Time Frame
Before intervention (preoperative unit) and at an average of 30 minutes after surgery (at the post-anesthesia care unit)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rodrigo López, MD
Organizational Affiliation
Pontificia Universidad Catolica de Chile
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Hospital - Pontificia Universidad Católica de Chile
City
Santiago
State/Province
RM
ZIP/Postal Code
8330024
Country
Chile
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
11429348
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.
Results Reference
background
PubMed Identifier
21771174
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.
Results Reference
background
Learn more about this trial
Impact of Music in the Preoperative Stress of Children Undergoing General Surgery
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