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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02947919
Other study ID # 15-242
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date July 2016
Est. completion date August 2016

Study information

Verified date April 2019
Source Pontificia Universidad Catolica de Chile
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 7 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Chile Clinical Hospital - Pontificia Universidad Católica de Chile Santiago RM

Sponsors (1)

Lead Sponsor Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

References & Publications (2)

McCann ME, Kain ZN. The management of preoperative anxiety in children: an update. Anesth Analg. 2001 Jul;93(1):98-105. Review. — View Citation

Wennström B, Törnhage 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 M-YPAS M-YPAS (Yale Preoperative Anxiety Scale) Before intervention (preoperative unit) and at an average of 30 minutes after surgery (at the post-anesthesia care unit)
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