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

Mustafa Kemalpasa Government Hospital

Status: Completed

Conditions: Temperament; Hyperemesis Gravidarum; Morning Sickness

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02541682

TUTF-GOKAEK 2013/50

Details and patient eligibility

About

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.

Enrollment: 252 patients

Sex: Female

Ages: 16 to 41 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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252 participants in 4 patient groups

Control

Other group

Description:

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.

Treatment:

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

Mild nausea and vomiting of pregnancy

Other group

Description:

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.

Treatment:

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

Moderate nausea and vomiting of pregnancy

Other group

Description:

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.

Treatment:

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

Severe nausea and vomiting of pregnancy

Other group

Description:

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.

Treatment:

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