Stress, PhysiologicalNCT02947919
Impact of Music in the Preoperative Stress of Children Undergoing General Surgery
A study testing Music in people with Stress, Physiological and Stress, Psychological, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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. Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Physiological, Stress, Psychological
- What is being tested?
- Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChile
- Study dates
- Jul 2016to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Elective surgery
- ASA I-II
- Parents' consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Chile1 site
Clinical Hospital - Pontificia Universidad Católica de Chile
Santiago, RM, 8330024
About this study
Official title: Impacto de la música en el estrés Preoperatorio en niños Sometidos a cirugía General
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.
- Conditions
- Stress, Physiological, Stress, Psychological
- Being tested
- Music
- Keywords
- Perioperative Period, Music
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicBehavioural
A previously defined list of songs will be administered by headphones to these patients with an MP3 device with headphones.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Music in the perioperative period Receives: Behavioral: Music |
| Control | No intervention | Usual treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in salivary cortisol concentration
Measured: 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)
Measured: Before intervention (preoperative unit) and at an average of 30 minutes after surgery (at the post-anesthesia care unit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Why it stopped: Problems with samples handling
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stress, PhysiologicalStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rodrigo López, MD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947919
- Sponsor's protocol ID
- 15-242
- Status last verified
- Apr 2019
- First submitted
- 13 Oct 2016
- Last updated
- 26 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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 11429348Wennstrom 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacto de la música en el estrés Preoperatorio en niños Sometidos a cirugía General
- ClinicalTrials.gov ID
- NCT02947919
- Acronym / sponsor ID
- 15-242
- Conditions
- Stress, Physiological, Stress, Psychological
- Keywords
- Perioperative Period, Music
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Problems with samples handling
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 28 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: MusicMusic in the perioperative period |
| Control | No intervention | –Usual treatment |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Elective surgery
- ASA I-II
- Parents' consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicA previously defined list of songs will be administered by headphones to these patients with an MP3 device with headphones. | Behavioural | Intervention |
Primary outcome
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)
1 secondary outcome
M-YPAS
Time frame: Before intervention (preoperative unit) and at an average of 30 minutes after surgery (at the post-anesthesia care unit)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2019.
- Background: PubMed 11429348McCann 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.
- Background: PubMed 21771174Wennstrom 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo López, MD principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Stress, Physiological and Stress, Psychological, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02947919, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2019.