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CompletedNCT02695615Updated Mar 1, 2016

Stress During Elective or Emergency Cesarean Operations

An observational study in Anxiety, sponsored by Umraniye Education and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-01.

Sponsored by Umraniye Education and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
60
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Anxiety

Keywords

  • cesarean operation
  • Spielberger State Trait Anxiety Inventory
  • pain
03

In context

Anxiety Disorders

5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.

This study's enrollment of 60 is below the median of 148 across 630 observational studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Umraniye Education and Research Hospital is the lead sponsor of 61 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study included pregnant women aged ≥18 years (gestational age: 37-40 weeks) in whom emergent or elective C/S was indicated

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • pregnant women aged ≥18 years (gestational age: 37-40 weeks) underwent emergent or elective C/S.

Exclusion criteria

Exclusion Criteria:

  • patients with cardiopulmonary,
  • renal,
  • hepatic or
  • psychiatric disease,
  • obstetric-fetal anomaly and
  • weighing ≥ 100 kg were excluded.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
60 participants (actual)
Target follow-up
1 Day
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. correlation between maternal anxiety and age according to emergent or elective C/S under general anesthesia.

    Time frame: during operation

  2. correlation between maternal anxiety and body mass index according to emergent or elective C/S under general anesthesia.

    Time frame: during operation

Secondary outcomes

  1. correlation between maternal anxiety and parity-gravidity according to emergent or elective C/S under general anesthesia.

    Time frame: during the operation

  2. correlation between maternal anxiety and patient satisfaction according to emergent or elective C/S under general anesthesia.

    Time frame: during the operation

  3. correlation between maternal anxiety and postoperative pain according to emergent or elective C/S under general anesthesia.

    Time frame: during the operation

07

Study locations

1 site
  • gulsah Karaoren
    Istanbul, Turkey (Türkiye)
08

References and documents

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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2014, a primary completion of Jan 2015 and a completion of Mar 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 24, 2016
First posted
Mar 1, 2016
Start
Jan 2014
Primary completionActual
Jan 2015
CompletionActual
Mar 2015
Last update
Mar 1, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02695615
Lead sponsor
Umraniye Education and Research Hospital
Responsible party
Gulsah Karaoren (MD, Umraniye Education and Research Hospital) — Principal investigator
First posted
Mar 1, 2016
Start date
Jan 2014
Primary completion
Jan 2015
Completion
Mar 2015
Last update
Mar 1, 2016

Study contacts

Muhammed A Erkmen, MD
study chair · Umraniye Education and Research Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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