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

Not Applicable

Completed

• Conditions: Temperament; Morning Sickness; Hyperemesis Gravidarum
• Interventions: Other: TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire)

• Registration Number: NCT02541682
• Lead Sponsor: Mustafa Kemalpasa Government Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2015-04
• Study Completion: 2015-07
• Study First Submitted: 2015-08-30
• Study First Submitted QC: 2015-09-02
• Study First Posted: 2015-09-04
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-20
• Last Update Posted: 2015-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 252

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control	TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire)	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.
Mild nausea and vomiting of pregnancy	TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire)	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.
Moderate nausea and vomiting of pregnancy	TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire)	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.
Severe nausea and vomiting of pregnancy	TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Hospital anxiety and depression scale	1 day	Used for excluding patients with the risk of anxiety disorder or depression.

Trial Locations

Locations (1)

Mustafakemalpasa Government Hospital; 🇹🇷 Bursa, Turkey