|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02947919 |
|
Date of registration:
|
13/10/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Impact of Music in the Preoperative Stress of Children Undergoing General Surgery
|
|
Scientific title:
|
Impacto de la música en el estrés Preoperatorio en niños Sometidos a cirugía General |
|
Date of first enrolment:
|
July 2016 |
|
Target sample size:
|
0 |
|
Recruitment status: |
Withdrawn |
|
URL:
|
https://clinicaltrials.gov/show/NCT02947919 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Investigator, Outcomes Assessor).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Chile
| | | | | | | |
|
Contacts
|
|
Name:
|
Rodrigo López, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Pontificia Universidad Catolica de Chile |
| | |
|
Key inclusion & exclusion 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
Age minimum:
5 Years
Age maximum:
7 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Stress, Physiological
|
|
Stress, Psychological
|
|
Intervention(s)
|
|
Behavioral: Music
|
|
Primary Outcome(s)
|
|
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(s)
|
|
M-YPAS
[Time Frame: Before intervention (preoperative unit) and at an average of 30 minutes after surgery (at the post-anesthesia care unit)]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|