Assessment of the Relationship Between Affective Temperament and the Severity of Nausea and Vomiting in Early Pregnancy
Keywords
Abstract
Dates
| Last Verified: | 10/31/2015 |
| First Submitted: | 08/29/2015 |
| Estimated Enrollment Submitted: | 09/01/2015 |
| First Posted: | 09/03/2015 |
| Last Update Submitted: | 11/19/2015 |
| Last Update Posted: | 11/22/2015 |
| Actual Study Start Date: | 02/28/2013 |
| Estimated Primary Completion Date: | 03/31/2015 |
| Estimated Study Completion Date: | 06/30/2015 |
Condition or disease
Intervention/treatment
Other: TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire)
Phase
Arm Groups
| 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: 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: 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: 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. |
Eligibility Criteria
| Ages Eligible for Study | 16 Years To 16 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. TEMPS-A scale measurement [1 day]
2. PUQE scoring index [2 months]
Secondary Outcome Measures
1. Hospital anxiety and depression scale [1 day]
