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

Study Overview
=================
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.

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

Conditions
-----------------
Hyperemesis Gravidarum, Temperament, Morning Sickness

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 41 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>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)<br>* Participants filled out the TEMPS-A survey at their first visit.<br>|
| Other: Mild nausea and vomiting of pregnancy<br>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)<br>* Participants filled out the TEMPS-A survey at their first visit.<br>|
| Other: Moderate nausea and vomiting of pregnancy<br>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)<br>* Participants filled out the TEMPS-A survey at their first visit.<br>|
| Other: Severe nausea and vomiting of pregnancy<br>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)<br>* Participants filled out the TEMPS-A survey at their first visit.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TEMPS-A scale measurement | The participants filled out TEMPS-A survey at their first visit. | 1 day | 
| PUQE scoring index | 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 | Used for excluding patients with the risk of anxiety disorder or depression. | 1 day |