How Anxiety in Pregnant Hospitalized Women Change wIth Internet Use

NCT02601261 | Completed

• 1 other identifier: HAWAII
• Study Type: observational
• Target: 105
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Pregnant Women in All Gestational Ages Hospitalized for a Problem of Pregnancy

Keywords

pregnant; gestational ages; hospitalized; problem of pregnancy

Outcome Measures

Primary Outcomes (1)

• The association between the use of Internet and the level of anxiety in pregnant hospitalized women.

  During the first day of hospitalization, the field investigator administers to every patient participating to the study all five questionnaires and on each questionnaire, it will be indicated the day when it has been completed. The study measures the level of state anxiety in hospitalized women with pathological pregnancy, influenced by internet use. The STAI questionnaire that evaluate the level of anxiety, is divided in to parts: the first part aims to determinate the state anxiety and it will be administered every other day, while the second part will discuss the anxiety itself, and has to completed only once.

  10 days

Secondary Outcomes (3)

• Using STAI questionnaire to evaluate how the level of anxiety changes during the hospitalization, in women with pathological pregnancy.

  10 days

• 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

  10 days

• 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.

  10 days

Study Arms (2)

Patients with some access to internet during stay

Other: At the first day of hospitalization the field investigator will submit to pregnant women in a pathological condition five questionnaires

Patients without access to internet during stay

Other: At the first day of hospitalization the field investigator will submit to pregnant women in a pathological condition five questionnaires

Interventions

At the first day of hospitalization the field investigator will submit to pregnant women in a pathological condition five questionnaires OTHER

Some of these questionnaires will have to be completed every day and others every other day: 1. The Internet questionnaire is divided in two parts. The first one investigates the use of internet at home and it will be administered only once, the second part will investigate the internet use at the hospital, in the case the women have a personal smartphone, tablet or personal computer (they are the owners) and it will be administered every other days. 2. The questionnaire is aimed to understand the quality of life (EQ-5D) will be administered only once, at the beginning of the hospitalization. 3. The STAI questionnaire is divided in to parts, the first part aims to determinate the state anxiety and it will be administered every other day, while the second part will discuss the anxiety itself, and has to completed only once. 4. The short questionnaire on critical events occurring during the day, 5. The short questionnaire with obstetric anamnesis.

Patients with some access to internet during stay; Patients without access to internet during stay

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Padova: lead
• Azienda Ospedaliero Universitaria, Santa Maria della Misericordia di Udine, Italy: collaborator
• Azienda Per I Servizi Sanitari N. 6 Friuli Occidentale: collaborator

Related Publications (14)

• Rubertsson C, Hellstrom J, Cross M, Sydsjo G. Anxiety in early pregnancy: prevalence and contributing factors. Arch Womens Ment Health. 2014 Jun;17(3):221-8. doi: 10.1007/s00737-013-0409-0. Epub 2014 Jan 18.

  PMID: 24442712 BACKGROUND

• van Batenburg-Eddes T, de Groot L, Huizink AC, Steegers EA, Hofman A, Jaddoe VW, Verhulst FC, Tiemeier H. Maternal symptoms of anxiety during pregnancy affect infant neuromotor development: the generation R study. Dev Neuropsychol. 2009;34(4):476-93. doi: 10.1080/87565640902964508.

  PMID: 20183712 BACKGROUND

• Field T, Diego M, Hernandez-Reif M, Figueiredo B, Deeds O, Ascencio A, Schanberg S, Kuhn C. Comorbid depression and anxiety effects on pregnancy and neonatal outcome. Infant Behav Dev. 2010 Feb;33(1):23-9. doi: 10.1016/j.infbeh.2009.10.004. Epub 2009 Nov 27.

  PMID: 19945170 BACKGROUND

• Fishell A. Depression and anxiety in pregnancy. J Popul Ther Clin Pharmacol. 2010 Fall;17(3):e363-9. Epub 2010 Oct 26.

  PMID: 21041870 BACKGROUND

• O'Connor TG, Heron J, Golding J, Beveridge M, Glover V. Maternal antenatal anxiety and children's behavioural/emotional problems at 4 years. Report from the Avon Longitudinal Study of Parents and Children. Br J Psychiatry. 2002 Jun;180:502-8. doi: 10.1192/bjp.180.6.502.

  PMID: 12042228 BACKGROUND

• Austin MP, Hadzi-Pavlovic D, Leader L, Saint K, Parker G. Maternal trait anxiety, depression and life event stress in pregnancy: relationships with infant temperament. Early Hum Dev. 2005 Feb;81(2):183-90. doi: 10.1016/j.earlhumdev.2004.07.001.

  PMID: 15748973 BACKGROUND

• Van den Bergh BR, Marcoen A. High antenatal maternal anxiety is related to ADHD symptoms, externalizing problems, and anxiety in 8- and 9-year-olds. Child Dev. 2004 Jul-Aug;75(4):1085-97. doi: 10.1111/j.1467-8624.2004.00727.x.

  PMID: 15260866 BACKGROUND

• O'Connor TG. Annotation: The 'effects' of parenting reconsidered: findings, challenges, and applications. J Child Psychol Psychiatry. 2002 Jul;43(5):555-72. doi: 10.1111/1469-7610.00046.

  PMID: 12120853 BACKGROUND

• Beijers R, Jansen J, Riksen-Walraven M, de Weerth C. Maternal prenatal anxiety and stress predict infant illnesses and health complaints. Pediatrics. 2010 Aug;126(2):e401-9. doi: 10.1542/peds.2009-3226. Epub 2010 Jul 19.

  PMID: 20643724 BACKGROUND

• Gao LL, Larsson M, Luo SY. Internet use by Chinese women seeking pregnancy-related information. Midwifery. 2013 Jul;29(7):730-5. doi: 10.1016/j.midw.2012.07.003. Epub 2012 Sep 5.

  PMID: 22958935 BACKGROUND

• Lee AM, Lam SK, Sze Mun Lau SM, Chong CS, Chui HW, Fong DY. Prevalence, course, and risk factors for antenatal anxiety and depression. Obstet Gynecol. 2007 Nov;110(5):1102-12. doi: 10.1097/01.AOG.0000287065.59491.70.

  PMID: 17978126 BACKGROUND

• Julian LJ. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S467-72. doi: 10.1002/acr.20561. No abstract available.

  PMID: 22588767 BACKGROUND

• Minto C, Bauce B, Calore C, Rigato I, Folino F, Soriani N, Hochdorn A, Iliceto S, Gregori D. Is Internet use associated with anxiety in patients with and at risk for cardiomyopathy? Am Heart J. 2015 Jul;170(1):87-95, 95.e1-4. doi: 10.1016/j.ahj.2015.02.024. Epub 2015 Apr 9.

  PMID: 26093868 BACKGROUND

• Ibanez G, Charles MA, Forhan A, Magnin G, Thiebaugeorges O, Kaminski M, Saurel-Cubizolles MJ; EDEN Mother-Child Cohort Study Group. Depression and anxiety in women during pregnancy and neonatal outcome: data from the EDEN mother-child cohort. Early Hum Dev. 2012 Aug;88(8):643-9. doi: 10.1016/j.earlhumdev.2012.01.014. Epub 2012 Feb 22.

  PMID: 22361259 RESULT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: November 10, 2015
• Study Start: August 1, 2015
• Primary Completion: March 31, 2016
• Study Completion: December 31, 2016
• Last Updated: April 28, 2021

Record last verified: 2021-04