Post-operative DeliriumNCT01993992
Parental Anxiety and Its Relationship With Pediatric Patients' Post-operative Responses
An observational study of Post-operative Delirium and Children, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Post-operative delirium had multiple risk factors, such as pre-operative anxiety status, post-operative pain, and anesthetic method. We currently decrease pre-operative anxiety by parental accompanying until the children put to sleep. Read more about this study
- Who is it for?
- Ages Up to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-operative Delirium, Children, Anxiety
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2013to Dec 2016
- Phase
- Observational
- 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 Up to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Age younger than 16-year-old who required surgery
Who may be able to join
- American Society Anesthesia (ASA) risks classification I or II
Who cannot join
- Parents who have cognitive problems
- Parents who have difficulty finishing questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Post-operative delirium had multiple risk factors, such as pre-operative anxiety status, post-operative pain, and anesthetic method. We currently decrease pre-operative anxiety by parental accompanying until the children put to sleep. However, references indicate that parental anxiety can increase the post-operative delirium. Heart rate variability was used to measure the anxiety status of parents. We think sympathetic tone elevation measured by heart rate variability may not induce by anxiety alone, thus we want to explore this question by using Stat-Trait Anxiety Inventory questionnaire.
Read the detailed description
Outcome measures
- Post-operative emergence delirium, observed with an average duration up to 24 hours
- Sedatives used in recovery unit
- Conditions
- Post-operative Delirium, Children, Anxiety
- Keywords
- Anesthesia
- Medical subject headings
- Emergence Delirium, Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of emergence delirium
Measured: after operation, with an average duration up to 24 hours
Secondary outcomes (2)
recovery room stay time
Measured: after operation, with an average duration up to 24 hours
Sedatives used in recovery room
Measured: after operation, with an average duration up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative DeliriumStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YI-CHIA WANG, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993992
- Sponsor's protocol ID
- 201310021RIND
- Status last verified
- Jul 2015
- First submitted
- 3 Nov 2013
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Anxiety and Its Relationship With Pediatric Patients' Post-operative Responses
- ClinicalTrials.gov ID
- NCT01993992
- Acronym / sponsor ID
- 201310021RIND
- Conditions
- Post-operative Delirium, Children, Anxiety
- Keywords
- Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 25 Nov 2013 (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.
Post-operative delirium had multiple risk factors, such as pre-operative anxiety status, post-operative pain, and anesthetic method. We currently decrease pre-operative anxiety by parental accompanying until the children put to sleep. However, references indicate that parental anxiety can increase the post-operative delirium. Heart rate variability was used to measure the anxiety status of parents. We think sympathetic tone elevation measured by heart rate variability may not induce by anxiety alone, thus we want to explore this question by using Stat-Trait Anxiety Inventory questionnaire.
Detailed description
Outcome measures
- Post-operative emergence delirium, observed with an average duration up to 24 hours
- Sedatives used in recovery unit
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Age younger than 16-year-old who required surgery
Key inclusion criteria (1 listed)
- American Society Anesthesia (ASA) risks classification I or II
Key exclusion criteria (2 listed)
- Parents who have cognitive problems
- Parents who have difficulty finishing questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
degree of emergence delirium
Time frame: after operation, with an average duration up to 24 hours
2 secondary outcomes
recovery room stay time
Time frame: after operation, with an average duration up to 24 hours
Sedatives used in recovery room
Time frame: after operation, with an average duration up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 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.
YI-CHIA WANG principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-operative Delirium and Children, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Jul 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 Taiwan. 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?
Results are not available in the source record.
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?
degree of emergence delirium (time frame: after operation, with an average duration up to 24 hours). 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 8 Jul 2015; AzTrials last refreshed its copy on 7 Nov 2026.