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Completed

NCT Number: NCT02541682

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

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.

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Key information

Age range

16 year–41 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mustafakemalpasa Government Hospital

Bursa, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire)

Other

Participants filled out the TEMPS-A survey at their first visit.

Primary outcomes

  1. TEMPS-A scale measurement

    Time frame: 1 day

    The participants filled out TEMPS-A survey at their first visit.

  2. PUQE scoring index

    Time frame: 2 months

    The investigators performed this test to subjects three times of session separated by a month

Secondary outcomes

  1. Hospital anxiety and depression scale

    Time frame: 1 day

    Used for excluding patients with the risk of anxiety disorder or depression.

Sponsors and collaborators

Lead sponsor

Mustafa Kemalpasa Government Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 4, 2015
Registry last updated
Nov 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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