NCT02695615

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 1, 2016

Completed
Last Updated

March 1, 2016

Status Verified

February 1, 2016

Enrollment Period

1 year

First QC Date

February 24, 2016

Last Update Submit

February 29, 2016

Conditions

Anxiety

Keywords

cesarean operationSpielberger State Trait Anxiety Inventorypain

Outcome Measures

Primary Outcomes (2)

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

    during operation

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

    during operation

Secondary Outcomes (3)

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

    during the operation

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

    during the operation

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

    during the operation

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

gulsah Karaoren

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 12419719BACKGROUND

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Muhammed A Erkmen, MD

    Umraniye Education and Research Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 24, 2016

First Posted

March 1, 2016

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

March 1, 2015

Last Updated

March 1, 2016

Record last verified: 2016-02

Locations

TU(1)