Assessment of the Relationship Between Affective Temperament and the Severity of Nausea and Vomiting in Early Pregnancy

November 20, 2015 updated by: ALI BAHADIRLI, Mustafa Kemalpasa Government Hospital
In this study, the investigators aimed to research the relationship between affective temperament with the severity of the symptoms of nausea and vomiting in early pregnancy. The investigators aimed to assess temperament differences between healthy pregnant women and pregnant women suffering from mild, moderate, and severe hyperemesis gravidarum.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

252

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bursa, Turkey
        • Mustafakemalpasa Government Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 41 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • To be 16 years or older
  • To be at the level of education to understand and answer the survey questions
  • To have singleton live pregnancy within the first six weeks of pregnancy according to ultrasound measurement or the level of human chorionic gonadotropine in the blood
  • Agreed to participate the study by signing a voluntary informed consent form

Exclusion Criteria:

  • History of any medical problems (eg. endocrine, gastrointestinal, cardiovascular, pulmonary system diseases, vertigo)
  • Presence of a history of psychiatric disorder (eg. depression, anxiety, bipolar disorder, delirium, eating disorders and other psychotic disorders)
  • Multiple pregnancy
  • Pregnancy complicating situation (eg. imminent abortion, trophoblastic disease, ectopic pregnancy)
  • Presence of a history of regular medication use (Including drug use within the last six months for psychiatric illness)
  • To be not at the risk for anxiety disorder or depression according to the result of hospital anxiety and depression scale

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control
Participants who have PUQE ( Pregnancy Unique Quantification of Emesis scoring index) score equal to 3 and showing no symptom of nausea and/or vomiting during the three control visits. Control visits are performed a month apart.
Other: TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire)
Participants filled out the TEMPS-A survey at their first visit.
Other: Mild nausea and vomiting of pregnancy
Participants who have maximum PUQE ( Pregnancy Unique Quantification of Emesis scoring index) score equal to 4-6 during the three control visits. Control visits are performed a month apart.
Other: TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire)
Participants filled out the TEMPS-A survey at their first visit.
Other: Moderate nausea and vomiting of pregnancy
Participants who have maximum PUQE ( Pregnancy Unique Quantification of Emesis scoring index) score equal to 7-12 during the three control visits. Control visits are performed a month apart.
Other: TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire)
Participants filled out the TEMPS-A survey at their first visit.
Other: Severe nausea and vomiting of pregnancy
Participants who have maximum PUQE ( Pregnancy Unique Quantification of Emesis scoring index) score equal to 13-15 during the three control visits. Control visits are performed a month apart.
Other: TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire)
Participants filled out the TEMPS-A survey at their first visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TEMPS-A scale measurement
Time Frame: 1 day
The participants filled out TEMPS-A survey at their first visit.
1 day
PUQE scoring index
Time Frame: 2 months
The investigators performed this test to subjects three times of session separated by a month
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital anxiety and depression scale
Time Frame: 1 day
Used for excluding patients with the risk of anxiety disorder or depression.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mustafa Kemalpasa Government Hospital

Investigators

  • Principal Investigator: ALI BAHADIRLI, M.D., Recruiting

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

August 30, 2015

First Submitted That Met QC Criteria

September 2, 2015

First Posted (Estimate)

September 4, 2015

Study Record Updates

Last Update Posted (Estimate)

November 23, 2015

Last Update Submitted That Met QC Criteria

November 20, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUTF-GOKAEK 2013/50

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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