AnxietyNCT02695615
Stress During Elective or Emergency Cesarean Operations
An observational study of Anxiety, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
We investigated a correlation between maternal anxiety and age, body mass index (BMI), parity-gravidity, patient satisfaction, antenatal care, postoperative pain according to emergent or elective C/S under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Mar 2015
- How long will I take part?
- 1 Day
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The study included pregnant women aged ≥18 years (gestational age: 37-40 weeks) in whom emergent or elective C/S was indicated
Who may be able to join
- pregnant women aged ≥18 years (gestational age: 37-40 weeks) underwent emergent or elective C/S.
Who cannot join
- patients with cardiopulmonary,
- renal,
- hepatic or
- psychiatric disease,
- obstetric-fetal anomaly and
- weighing ≥ 100 kg were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of the Effects of Stress During Elective or Emergency Cesarean Operations; Prospective, Randomized Clinical Trial
We investigated a correlation between maternal anxiety and age, body mass index (BMI), parity-gravidity, patient satisfaction, antenatal care, postoperative pain according to emergent or elective C/S under general anesthesia.
- Conditions
- Anxiety
- Keywords
- cesarean operation, Spielberger State Trait Anxiety Inventory, pain
- Medical subject headings
- Anxiety Disorders, Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between maternal anxiety and age according to emergent or elective C/S under general anesthesia.
Measured: during operation
correlation between maternal anxiety and body mass index according to emergent or elective C/S under general anesthesia.
Measured: during operation
Secondary outcomes (3)
correlation between maternal anxiety and parity-gravidity according to emergent or elective C/S under general anesthesia.
Measured: during the operation
correlation between maternal anxiety and patient satisfaction according to emergent or elective C/S under general anesthesia.
Measured: during the operation
correlation between maternal anxiety and postoperative pain according to emergent or elective C/S under general anesthesia.
Measured: during the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gulsah Karaoren, Umraniye Education and Research Hospital
- Investigators
- Muhammed A Erkmen, MD, Study chair, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02695615
- Sponsor's protocol ID
- GK10
- Status last verified
- Feb 2016
- First submitted
- 24 Feb 2016
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Duggan M, Dowd N, O'Mara D, Harmon D, Tormey W, Cunningham AJ. Benzodiazepine premedication may attenuate the stress response in daycase anesthesia: a pilot study. Can J Anaesth. 2002 Nov;49(9):932-5. doi: 10.1007/BF03016877.
PubMed 12419719
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Effects of Stress During Elective or Emergency Cesarean Operations; Prospective, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02695615
- Acronym / sponsor ID
- GK10
- Conditions
- Anxiety
- Keywords
- cesarean operation, Spielberger State Trait Anxiety Inventory, pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 1 Mar 2016 (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.
We investigated a correlation between maternal anxiety and age, body mass index (BMI), parity-gravidity, patient satisfaction, antenatal care, postoperative pain according to emergent or elective C/S under general anesthesia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study included pregnant women aged ≥18 years (gestational age: 37-40 weeks) in whom emergent or elective C/S was indicated
Key inclusion criteria (1 listed)
- pregnant women aged ≥18 years (gestational age: 37-40 weeks) underwent emergent or elective C/S.
Key exclusion criteria (6 listed)
- patients with cardiopulmonary,
- renal,
- hepatic or
- psychiatric disease,
- obstetric-fetal anomaly and
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
correlation between maternal anxiety and age according to emergent or elective C/S under general anesthesia.
Time frame: during operation
correlation between maternal anxiety and body mass index according to emergent or elective C/S under general anesthesia.
Time frame: during operation
3 secondary outcomes
correlation between maternal anxiety and parity-gravidity according to emergent or elective C/S under general anesthesia.
Time frame: during the operation
correlation between maternal anxiety and patient satisfaction according to emergent or elective C/S under general anesthesia.
Time frame: during the operation
correlation between maternal anxiety and postoperative pain according to emergent or elective C/S under general anesthesia.
Time frame: during the operation
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 1 Mar 2016.
- Background: PubMed 12419719Duggan M, Dowd N, O'Mara D, Harmon D, Tormey W, Cunningham AJ. Benzodiazepine premedication may attenuate the stress response in daycase anesthesia: a pilot study. Can J Anaesth. 2002 Nov;49(9):932-5. doi: 10.1007/BF03016877.
- Individual participant dataSharing planned: Undecided
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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.
Muhammed A Erkmen, MD study chair
Umraniye Education and Research 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 Anxiety, run by Umraniye Education and Research Hospital 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 1 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 1 Mar 2016. 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?
correlation between maternal anxiety and age according to emergent or elective C/S under general anesthesia. (time frame: during operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02695615, which also lists 1 linked publication.
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 1 Mar 2016.