CClinicalTrials.gg
WithdrawnNCT02947919Updated Apr 26, 2019

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

An interventional study of Music in Stress, Physiological and Stress, Psychological, sponsored by Pontificia Universidad Catolica de Chile. Withdrawn at 1 site in Chile. Open to participants aged 5 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-04-26.

Sponsored by Pontificia Universidad Catolica de Chile · Not applicable, Interventional, and Prevention

Why this study was withdrawn
Problems with samples handling
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
5 Years to 7 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stress, Physiological
  • Stress, Psychological

Browse trials for

Keywords

  • Perioperative Period
  • Music
03

In context

Stress, Psychological

783 studies on the registry are indexed under Stress, Psychological; 128 are open to participants now.

Browse Stress, Psychological studies →

Lead sponsor

Pontificia Universidad Catolica de Chile is the lead sponsor of 215 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Intervention

    Music in the perioperative period

    Behavioral: Music

  • No intervention
    Control

    Usual treatment

Interventions

  • BehavioralMusic

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

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. M-YPAS

    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)

07

Study locations

1 site
  • Clinical Hospital - Pontificia Universidad Católica de Chile
    Santiago, RM 8330024, Chile
08

References and documents

Publications

  • 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. PubMed 11429348 ↗
  • 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. PubMed 21771174 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02947919
Lead sponsor
Pontificia Universidad Catolica de Chile
Responsible party
Sponsor
First posted
Oct 28, 2016
Start date
Jul 2016
Primary completion
Aug 2016 (estimated)
Completion
Aug 2016 (estimated)
Last update
Apr 26, 2019

Study contacts

Rodrigo López, MD
principal investigator · Pontificia Universidad Catolica de Chile

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion