Heart Rate VariabilityNCT02011074
Perioperative Changes of Heart Rate Variability Related to Anxiety and Depressiveness in Patients Undergoing General Anesthesia
An observational study of Heart Rate Variability and STAI, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Preoperative anxiety can be detected via structured and standardised screening by the State - Trait Anxiety Inventory (STAI) and Self rating Depression Scale (SDS) questionnaire. Read more about this study
- Who is it for?
- Ages 30 to 80 years, men only
- Conditions the study is for
- Heart Rate Variability, STAI, SDS
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to Nov 2014
- 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 30 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Hepatocellular carinoma patients undegoing Hepatectomy with general anesthesia
Who may be able to join
- Hepatocellular carcinoma patients
Who cannot join
- uncontrolled hypertension uncontrolled diabetes mellitus known autonomic nerve dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Changes of Heart Rate Variability Related to Anxiety and Depressiveness in Psychologically Normal Patients Undergoing General Anesthesia
Preoperative anxiety can be detected via structured and standardised screening by the State - Trait Anxiety Inventory (STAI) and Self rating Depression Scale (SDS) questionnaire. The investigators evaluate the relation of perioperative anxiety and heart rate variability, also the impact of general anesthesia on the change of heart rate variability.
- Conditions
- Heart Rate Variability, STAI, SDS, General Anesthesia, Anxiety
- Medical subject headings
- Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Measured: change from baseline in HRV at 10 minutes after induction of general anesthesia
Secondary outcomes (1)
STAI score
Measured: change from baseline in HRV at 10 minutes after induction of general anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2013 (estimated)
- Study startMar 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Rate VariabilityStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Myung Hee Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011074
- Sponsor's protocol ID
- 2012-08-043
- Status last verified
- Nov 2014
- First submitted
- 28 Nov 2013
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Changes of Heart Rate Variability Related to Anxiety and Depressiveness in Psychologically Normal Patients Undergoing General Anesthesia
- ClinicalTrials.gov ID
- NCT02011074
- Acronym / sponsor ID
- 2012-08-043
- Conditions
- Heart Rate Variability, STAI, SDS, General Anesthesia, Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 13 Dec 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.
Preoperative anxiety can be detected via structured and standardised screening by the State - Trait Anxiety Inventory (STAI) and Self rating Depression Scale (SDS) questionnaire. The investigators evaluate the relation of perioperative anxiety and heart rate variability, also the impact of general anesthesia on the change of heart rate variability.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hepatocellular carinoma patients undegoing Hepatectomy with general anesthesia
Key inclusion criteria (1 listed)
- Hepatocellular carcinoma patients
Key exclusion criteria (1 listed)
- uncontrolled hypertension uncontrolled diabetes mellitus known autonomic nerve dysfunction
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
Heart rate variability
Time frame: change from baseline in HRV at 10 minutes after induction of general anesthesia
1 secondary outcome
STAI score
Time frame: change from baseline in HRV at 10 minutes after induction of general anesthesia
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 19 Nov 2014.
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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.
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 Heart Rate Variability and STAI, run by Samsung Medical Center 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 1 inclusion and 1 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 19 Nov 2014. 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?
Heart rate variability (time frame: change from baseline in HRV at 10 minutes after induction of general anesthesia). 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 19 Nov 2014.