Postoperative BehaviourNCT02339298
Intraoperative Music Application and Postoperative Behaviour in Children and Adolescents.
A study testing music application, only headphones and a caudal block in people with Postoperative Behaviour, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial summary
The purpose of the study is to evaluate whether intraoperative music application has a positive impact on postoperative behavior in children and adolescents. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Postoperative Behaviour
- What is being tested?
- music application, only headphones and a caudal block
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2009to Nov 2015
- 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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age: 4-16 years
- American Society of Anesthesiologists (ASA) physical status of 1 and 2
- elective inguinal herniotomy or circumcision
- general anaesthesia with sevoflurane and caudal block
- written informed consent available
Who cannot join
- age <4 or >16.99 years
- ASA physical status of 3 or higher
- emergency surgery
- no general anaesthesia with sevoflurane or/and caudal block
- no written informed consent available
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Children's Hospital
Zurich, Canton of Zurich, 8032
About this study
Official title: Impact of Intraoperative Music Application on Postoperative Behaviour in Children and Adolescents.
The purpose of the study is to evaluate whether intraoperative music application has a positive impact on postoperative behavior in children and adolescents.
Read the detailed description
After induction of anesthesia, paralyzation of the patient and subsequent intubation, a caudal block is applied. After positioning of the patient, headphones are placed on the patients head and in case of the interventional group, music is played. Previously, the volume of the music is adjusted to a range from 50 to 60 decibel. Headphones are removed before extubation.
Postoperative behaviour is evaluated by parents and by caretaking personnel in the recovery room at arrival, after 15 minutes and before discharge to the ward and at home by parents after one, two and four weeks using questionnaires.
sample size calculation: n = minimal number of required probands π = 70% (proportion of interest) → 0.7 π0 = 50% (null hypothesis proportion) → 0.5 μ = (100% - 90%power) → 1.28 v = 1.96 (level of significance p=0.05)
n > [ μ√ π(1- π) + v√ π0(1- π0)]2 / (π - π0) n > 61.4 + correction for drop-outs (+10%) n = 70 per group → 140 probands in total
- Conditions
- Postoperative Behaviour
- Being tested
- music application, only headphones, a caudal block
- Keywords
- Music Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music applicationOther
music is applied during anaesthesia using headphones
only headphonesOther
music is not applied, only headphones are placed
a caudal blockDrug
| Study group | Role | What they receive |
|---|---|---|
| Music group | Active comparator | music application Receives: Other: music application; Drug: a caudal block |
| Control group | Sham comparator | only headphones Receives: Other: only headphones; Drug: a caudal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occuring of a behaviour change
Patients are followed during the first 4 weeks after the operation by parents using a questionnaire in order to detect behaviour changes after the operation.
Measured: patients are followed during the first 4 weeks after the operation
Secondary outcomes (9)
occurring of postoperative vomiting
Measured: baseline
occurring of postoperative vomiting
Measured: 15 min after arrival at the recovery room
occurring of postoperative vomiting
Measured: before discharge to the ward, which means after an expected average stay of 2 hours at the recovery room
rating of the behaviour of the child in the recovery room by parents using a questionnaire
Measured: baseline
rating of the behaviour of the child in the recovery room by parents using a questionnaire
Measured: 15 min after arrival at the recovery room
rating of the behaviour of the child in the recovery room by parents using a questionnaire
Measured: before discharge to the ward, which means after an expected average stay of 2 hours at the recovery room
rating of the behaviour of the child in the recovery room by caretaking personnel using a questionnaire
Measured: baseline
rating of the behaviour of the child in the recovery room by caretaking personnel using a questionnaire
Measured: 15 min after arrival at the recovery room
rating of the behaviour of the child in the recovery room by caretaking personnel using a questionnaire
Measured: before discharge to the ward, which means after an expected average stay of 2 hours at the recovery room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study startJul 2009
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative BehaviourStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus Weiss, Prof., Principal investigator, University Children's Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339298
- Sponsor's protocol ID
- Music study StV 10/09
- Status last verified
- Nov 2015
- First submitted
- 12 Dec 2014
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intraoperative Music Application on Postoperative Behaviour in Children and Adolescents.
- ClinicalTrials.gov ID
- NCT02339298
- Acronym / sponsor ID
- Music study StV 10/09
- Conditions
- Postoperative Behaviour
- Keywords
- Music Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 15 Jan 2015 (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.
The purpose of the study is to evaluate whether intraoperative music application has a positive impact on postoperative behavior in children and adolescents.
Detailed description
After induction of anesthesia, paralyzation of the patient and subsequent intubation, a caudal block is applied. After positioning of the patient, headphones are placed on the patients head and in case of the interventional group, music is played. Previously, the volume of the music is adjusted to a range from 50 to 60 decibel. Headphones are removed before extubation.
Postoperative behaviour is evaluated by parents and by caretaking personnel in the recovery room at arrival, after 15 minutes and before discharge to the ward and at home by parents after one, two and four weeks using questionnaires.
sample size calculation: n = minimal number of required probands π = 70% (proportion of interest) → 0.7 π0 = 50% (null hypothesis proportion) → 0.5 μ = (100% - 90%power) → 1.28 v = 1.96 (level of significance p=0.05)
n > [ μ√ π(1- π) + v√ π0(1- π0)]2 / (π - π0) n > 61.4 + correction for drop-outs (+10%) n = 70 per group → 140 probands in total
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music group | Active comparator | Other: music application, Drug: a caudal blockmusic application |
| Control group | Sham comparator | Other: only headphones, Drug: a caudal blockonly headphones |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- age: 4-16 years
- American Society of Anesthesiologists (ASA) physical status of 1 and 2
- elective inguinal herniotomy or circumcision
- general anaesthesia with sevoflurane and caudal block
- written informed consent available
Key exclusion criteria (5 listed)
- age <4 or >16.99 years
- ASA physical status of 3 or higher
- emergency surgery
- no general anaesthesia with sevoflurane or/and caudal block
- no written informed consent available
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 |
|---|---|---|
| music applicationmusic is applied during anaesthesia using headphones | Other | Music group |
| only headphonesmusic is not applied, only headphones are placed | Other | Control group |
| a caudal block | Drug | Control group, Music group |
Primary outcome
Occuring of a behaviour change
Time frame: patients are followed during the first 4 weeks after the operation
Patients are followed during the first 4 weeks after the operation by parents using a questionnaire in order to detect behaviour changes after the operation.
9 secondary outcomes
occurring of postoperative vomiting
Time frame: baseline
occurring of postoperative vomiting
Time frame: 15 min after arrival at the recovery room
occurring of postoperative vomiting
Time frame: before discharge to the ward, which means after an expected average stay of 2 hours at the recovery room
rating of the behaviour of the child in the recovery room by parents using a questionnaire
Time frame: baseline
rating of the behaviour of the child in the recovery room by parents using a questionnaire
Time frame: 15 min after arrival at the recovery room
rating of the behaviour of the child in the recovery room by parents using a questionnaire
Time frame: before discharge to the ward, which means after an expected average stay of 2 hours at the recovery room
rating of the behaviour of the child in the recovery room by caretaking personnel using a questionnaire
Time frame: baseline
rating of the behaviour of the child in the recovery room by caretaking personnel using a questionnaire
Time frame: 15 min after arrival at the recovery room
rating of the behaviour of the child in the recovery room by caretaking personnel using a questionnaire
Time frame: before discharge to the ward, which means after an expected average stay of 2 hours at the recovery room
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2015.
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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.
Markus Weiss, Prof. principal investigator
University Children's Hospital, Zurich
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 application, only headphones and a caudal block in people with Postoperative Behaviour, run by University Children's Hospital, Zurich at 1 site in Switzerland.
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 5 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: finished, as of the sponsor's last update on 10 Nov 2015. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occuring of a behaviour change (time frame: patients are followed during the first 4 weeks after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Nov 2015.