Clinical trial NCT02601261: How Anxiety in Pregnant Hospitalized Women Change wIth Internet Use
Official title: How Anxiety in Pregnant Hospitalized Women Change wIth Internet Use
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnant Women in All Gestational Ages Hospitalized for a Problem of Pregnancy
Keywords: pregnant
gestational ages
hospitalized
problem of pregnancy
Lead sponsor: University of Padova
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy
name: Azienda Per I Servizi Sanitari N. 6 Friuli Occidentale
First posted: 2015-11-10
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The study has been powered to detect a difference on the average STAI state score (range 20-80) of 6 points between women with some access to internet during stay (at least 10 minutes/days of web browsing, besides e-mails) and those no accessing internet during stay. Assuming a Standard Deviation of the difference in STAI scores of about 8 points (art. 30-art. 33), and assuming that the ratio between the rate of women not using internet and that of women using internet is 0,42 (art. 31-art. 32) for specified alpha = 0.025 and power (1 - beta) of 90.0% a total of 109 women must be recruited (using a two-sample t-test with unknown variance).

Data entry will be based on e-CRF running on the REDCAP Clinical Data Management System of the Service for Clinical Trials and Biometrics (Department of Cardiology, Thoracic and Vascular Sciences, University of Padova).

Brief summary: Investigating the influence of Internet use to the level of state anxiety in hospitalized women with pathological pregnancy.

A recent research shown that the prevalence of antenatal anxiety changes during pregnancy at first trimester is 36.3%; the rate dropped to 32.3% at second trimester but increased again to 35.8% at third trimester (art. 29).According to the World Health Organization, mental health disorders are the leading cause of disease burden in woman from 15 to 44 years (art.6). A Swedish study indicated that the incidence of moderate or extreme symptoms of anxiety and depression of pregnant woman during the first trimester is 15,6% (art. 3).

Detailed description: WHAT CAUSES ANXIETY IN PREGNANT WOMEN

Anxiety during pregnancy may expose the woman to a higher risk of a negative outcome in four different fields:

1. Fetal obstetric outcomes; 2. Neonatal outcomes; 3. Child development; 4. Risk to the woman.

1. The anxiety in pregnant woman may expose the fetus to a higher risk of spontaneous early labor, preterm delivery, lower birth weight, fetal distress, fetal growth restriction, risk for spontaneous abortion, risk of pre-eclampsia and for operative/instrumental deliveries. Furthermore could be a major risk for the uterine artery to have high resistance that could reduce blood flow to the fetus.
2. The neonates that had a mother with anxiety issues during pregnancy may have an higher risk of admission to neonatal ICU, have a lower Apgar score and small head circumference, growth retardation, slowed mental development and excessive crying, irritability, hostility and erratic sleep. The mother anxiety could also increase the possibility to have colic in the neonatal age.
3. On the other hand the maternity anxiety could have long-term negative effects on the child development. There are risks of negative effect on maternal-infant bonding, difficult with affect regulations, cognitive delays, behavioral and emotional difficulties, maladaptive and social interactions, cognitive delays, behavioral and emotional difficulties and maladaptive social interactions. Furthermore, the child could develop a major level of fear and anxiety during life, an insecure and disorganized attachment and lower IQ at age 15-15 years. Anxiety of the mothers during pregnancy could cause a non-optimal neuromotorial development of the child, a research demonstrated an association between the anxiety of the mother in late pregnancy and the infant behavior, his emotional problems and his difficult temperament during later infancy. To demonstrated the correlation between anxiety and negative outcomes during childhood a Belgian/Dutch study showed that the 14-15 years old person that had a mother with anxiety disorders reveals a major risk of impulsivity and cognitive disorders. Another study demonstrated the connection between antenatal anxiety and behavioral/emotional problems of a four years old child. Another probable negative outcome of the pregnant anxiety is the asthma during childhood. A study demonstrated that the baby with a anxious mother has an higher risk to the use of antibiotic, to have respiratory and skin illnesses in the first year of the life than the child born from a mother without anxiety disorder.
4. It is very important underline to that anxiety during pregnancy has a negative effect not only on the fetus and child but also on the mother as well. Many researches demonstrated a link between prenatal anxiety and postpartum depression, psychiatric complications, and a higher risk of preeclampsia. In addition, the mother suffering of anxiety requires more examination from an obstetrician and most of all require an elective caesarean section. Other negative outcomes are poor nutrition, impaired self-care of the mother, failure to follow medical and prenatal guidelines, and major exposure to use alcohol, drugs and tobacco.

INTERNET INFORMATION In 2004 the 4,5% of the researches of internet were about medical information and, in 2009, the 61% of adult Internet users in the United States searched for health-related information. The Internet allows people to have an immediately health information and also pregnant woman search information about pregnancy and connected problems. For example women affected with nausea and vomiting during early pregnancy search online how this problem could be treated. On the other hand, not all information available on the Internet are regulated, nor are always reliable or current.

Eligibility criteria: Inclusion Criteria:

* Italian speaking and reading ability;
* Age \> 18 years
* Been hospitalized for a pathological pregnancy condition;
* Having a twin pregnancy;
* All gestational ages;
* Having been transferred from other hospitals.

Exclusion Criteria:

* Been under stressful family events (deaths, recent separation: self-reported)
* With a diagnosis of a mental psychiatric diseases;
* With a diagnosis of cancer pathology.

Primary outcomes:
measure: The association between the use of Internet and the level of anxiety in pregnant hospitalized women.
timeFrame: 10 days
Secondary outcomes:
measure: Using STAI questionnaire to evaluate how the level of anxiety changes during the hospitalization, in women with pathological pregnancy.
timeFrame: 10 days
measure: Using Internet questionnaire to determinate the type of health information pregnant women are seeking online during and before the hospitalization and the number of them
timeFrame: 10 days
measure: STAI questionnaire and Internet questionnaire used to compare the anxiety levels and the access to online health information between different subcategories: women having internet access during hospitalization and those who have not.
timeFrame: 10 days
Other outcomes:
Locations:
Study officials:
References:
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