AnxietyNCT03958578
The Effect of Preoperative Anxiety on Duration and Efficacy of Motor and Sensory Block in Spinal Anesthesia
An observational study of Anxiety, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
Spinal anaesthesia results in blockade of sympathetic efferent neurones. Patients with higher baseline sympathetic activation have been shown to have more marked hypotension after spinal anaesthesia. Anxiety causes generalized sympathetic activation. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2019to 1 Dec 2019
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: It is planned to enroll healthy individuals undergoing elective surgery under spinal anaesthesia.
Who may be able to join
- Patients aged between 18 and 55 years.
- ASA I-II
- BMI 18-25
Who cannot join
- Major surgery
Trial locations and contacts
1 site in 1 country.
About this study
Spinal anaesthesia results in blockade of sympathetic efferent neurones. Patients with higher baseline sympathetic activation have been shown to have more marked hypotension after spinal anaesthesia. Anxiety causes generalized sympathetic activation. It was aimed to find the effect of preoperative anxiety on the duration and efficacy of neuraxial anaesthesia.
- Conditions
- Anxiety
- Medical subject headings
- Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
State-Trait Anxiety Inventory questionnaire
State-Trait Anxiety Inventory questionnaire is a direct psychological assessment of preoperative anxiety.
Measured: 20-30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start1 May 2019
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yadigar Yılmaz, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03958578
- Sponsor's protocol ID
- OKMEYDANI EAH 48670771-514.10
- Status last verified
- Nov 2021
- First submitted
- 20 May 2019
- Last updated
- 23 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Anxiety on Duration and Efficacy of Motor and Sensory Block in Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT03958578
- Acronym / sponsor ID
- OKMEYDANI EAH 48670771-514.10
- Conditions
- Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 22 May 2019 (actual)
- 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.
Spinal anaesthesia results in blockade of sympathetic efferent neurones. Patients with higher baseline sympathetic activation have been shown to have more marked hypotension after spinal anaesthesia. Anxiety causes generalized sympathetic activation. It was aimed to find the effect of preoperative anxiety on the duration and efficacy of neuraxial anaesthesia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- It is planned to enroll healthy individuals undergoing elective surgery under spinal anaesthesia.
Key inclusion criteria (3 listed)
- Patients aged between 18 and 55 years.
- ASA I-II
- BMI 18-25
Key exclusion criteria (1 listed)
- Major surgery
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
State-Trait Anxiety Inventory questionnaire
Time frame: 20-30 minutes.
State-Trait Anxiety Inventory questionnaire is a direct psychological assessment of preoperative anxiety.
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 23 Nov 2021.
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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 Anxiety, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
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 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 23 Nov 2021. 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 Turkey (Türkiye). 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?
State-Trait Anxiety Inventory questionnaire (time frame: 20-30 minutes.). 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 23 Nov 2021.