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

NCT02947919 | Withdrawn

• 1 other identifier: 15-242
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Physiological; Stress, Psychological

Keywords

Perioperative Period; Music

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• M-YPAS

  Before intervention (preoperative unit) and at an average of 30 minutes after surgery (at the post-anesthesia care unit)

Study Arms (2)

Intervention

EXPERIMENTAL

Music in the perioperative period

Behavioral: Music

Control

NO INTERVENTION

Usual treatment

Interventions

Music BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Elective surgery
• ASA I-II
• Parents' consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Clinical Hospital - Pontificia Universidad Católica de Chile

Santiago, RM, 8330024, Chile

Location

Related Publications (2)

• 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.

  PMID: 11429348 BACKGROUND

• 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.

  PMID: 21771174 BACKGROUND

MeSH Terms

Conditions

Stress, Psychological

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Rodrigo López, MD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 28, 2016
• Study Start: July 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: April 26, 2019

Record last verified: 2019-04

Locations

CL (1)