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

Stress, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02947919
• Other study ID #: 15-242
• Status: Withdrawn
• Phase: N/A
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Stress, Physiological
• Stress, Psychological

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)