Closed Reduction Surgery for Nasal Bone FractureNCT02282865
The Relationship Between the Surgery-related Anxiety and HRV: Prediction for Aggressive Emergence Behavior
An observational study of Closed Reduction Surgery for Nasal Bone Fracture, run by Yonsei University at 1 site in South Korea.
Trial summary
Heart rate variability (HRV) is known to reflect the balance of autonomic nervous system. Anxiousness, which tend to result from the deficient action of parasympathetic nervous system, likely to show low HRV. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Closed Reduction Surgery for Nasal Bone Fracture
- How many people
- 140 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Sep 2014to 3 Mar 2017
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 20-60 years old male, ASA 1-2, scheduled for elective closed reduction for nasal bone fracture.
Who may be able to join
- 20-60 years old male, ASA 1-2
- scheduled for elective closed reduction for nasal bone fracture
Who cannot join
- Patients having hearing difficulties, Foreigner, taking any CNS related medication, history of any adverse drug reaction, Glasgow coma scale < 15
- patients with severe cardiopulmonary dysfunction
- patients taking any neurologic medication (anti-depressant, anti-convulsant, etc)
- patients taking any cardiovascular medication
- patients taking medications affecting the autonomic nervous system (a-blocker, b-blocker, etc)
- patients refusal
Trial locations and contacts
1 site in 1 country.
About this study
Heart rate variability (HRV) is known to reflect the balance of autonomic nervous system. Anxiousness, which tend to result from the deficient action of parasympathetic nervous system, likely to show low HRV. This study is to investigate the relationship between the surgery-related anxiety and the HRV which is known to reflect the balance of autonomic nervous system. Furthermore, this study also focuses on HRV's role as a predictor for aggressive emergence behavior, which might also be considered as partially related to imbalance of autonomic nervous system.
- Keywords
- Emergence agitation, Heart rate variability (HRV)
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Visual analogue scale (VAS) >5 | The degree of surgery-related anxiety assessment using VAS | |
| Visual analogue scale (VAS) ≤5 | The degree of surgery-related anxiety assessment using VAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
High frequency (HF) of Heart Rate Variability (HRV)
High frequency (HF) component of HRV, which represents the parasympathetic activity
Measured: from immediately after tracheal intubation to 5 min after tracheal intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study start11 Sep 2014
- Primary completion3 Mar 2017
- Study completion3 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Closed Reduction Surgery for Nasal Bone FractureStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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-control
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282865
- Sponsor's protocol ID
- 4-2014-0599
- Status last verified
- Jan 2019
- First submitted
- 31 Oct 2014
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between the Surgery-related Anxiety and HRV: Prediction for Aggressive Emergence Behavior
- ClinicalTrials.gov ID
- NCT02282865
- Acronym / sponsor ID
- 4-2014-0599
- Keywords
- Emergence agitation, Heart rate variability (HRV)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 11 Sep 2014 (actual)
- Primary completion
- 3 Mar 2017 (actual)
- Study completion
- 3 Mar 2017 (actual)
- First posted
- 5 Nov 2014 (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.
Heart rate variability (HRV) is known to reflect the balance of autonomic nervous system. Anxiousness, which tend to result from the deficient action of parasympathetic nervous system, likely to show low HRV. This study is to investigate the relationship between the surgery-related anxiety and the HRV which is known to reflect the balance of autonomic nervous system. Furthermore, this study also focuses on HRV's role as a predictor for aggressive emergence behavior, which might also be considered as partially related to imbalance of autonomic nervous system.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual analogue scale (VAS) >5 | – | –The degree of surgery-related anxiety assessment using VAS |
| Visual analogue scale (VAS) ≤5 | – | –The degree of surgery-related anxiety assessment using VAS |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 20-60 years old male, ASA 1-2, scheduled for elective closed reduction for nasal bone fracture.
Key inclusion criteria (2 listed)
- 20-60 years old male, ASA 1-2
- scheduled for elective closed reduction for nasal bone fracture
Key exclusion criteria (6 listed)
- Patients having hearing difficulties, Foreigner, taking any CNS related medication, history of any adverse drug reaction, Glasgow coma scale < 15
- patients with severe cardiopulmonary dysfunction
- patients taking any neurologic medication (anti-depressant, anti-convulsant, etc)
- patients taking any cardiovascular medication
- patients taking medications affecting the autonomic nervous system (a-blocker, b-blocker, etc)
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
High frequency (HF) of Heart Rate Variability (HRV)
Time frame: from immediately after tracheal intubation to 5 min after tracheal intubation
High frequency (HF) component of HRV, which represents the parasympathetic activity
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 29 Jan 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Closed Reduction Surgery for Nasal Bone Fracture, run by Yonsei University at 1 site in South Korea.
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 2 inclusion and 6 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 29 Jan 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 South Korea. 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 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?
High frequency (HF) of Heart Rate Variability (HRV) (time frame: from immediately after tracheal intubation to 5 min after tracheal intubation). 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 29 Jan 2019.