Clinical trial NCT05214846: Nulliparous Women and Education and Counseling
Official title: The Effect of Education and Counseling on Reducing Anxiety and Depression in Nullipar Pregnancy Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: nulliparous momen
Lead sponsor: Ondokuz Mayıs University
Sponsor class: OTHER
First posted: 2022-01-31
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This randomized controlled study was conducted at state hospital of nothern Turkey Obstetrics and Gynecology polyclinic between January 2021 and January 2022. The CONSORT (Consolidated Standards of Reporting Trials) guidelines for reporting randomised controlled trials (RCTs) has been used to describe the methods.
Primary purpose: PREVENTION

Brief summary: This study investigates the effect of education and counseling on anxiety and depression in nullipar women.

Detailed description: Pregnancy is a special process in a woman's life in which physiological, social and psychological changes occur. In this process, most women experience anxiety and depression, which are an important global health problem.The fear of uncertainty experienced by women who will become mothers for the first time may cause them to experience more anxiety/depression. The aim of this study was to investigate the effect of education and counseling on anxiety and depression of women.

This randomized controlled study was conducted at state hospital in northern Turkey , Obstetrics and Gynecology polyclinic between January 2022 and March 2022. Volunteer women undergoing polyclinic have been included. Participants were randomly assigned to the intervention or the control group using a computer-generated list. A data collection form including socio-demographic and obstetric characteristics such as age, educational status, Hospital Anxiety Depression Scale (HADS) was used for each patient. After obtaining written informed consent, the data collection form, Hospital Anxiety Depression Scale (HADS) were applied to both groups by face to face interview. Immediately after the questionnaires were applied, the nurse gave individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. Participants in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention (education and counseling) was performed.The IBM SPSS (Statistical package for the Social Sciences) 23.0 package program was used to evaluate the data obtained in the study.

Eligibility criteria: Inclusion Criteria:

* A healthy pregnant woman over 18 years of age,
* without a diagnosed psychiatric disease,
* without mental disability and communication problems,
* at 28 weeks of gestation,
* nulliparous,
* without fetal anomaly,
* without risky pregnancy

Exclusion Criteria:

* A healthy pregnant woman under 18 years of age,
* with a diagnosed psychiatric disease,
* with mental disability and communication problems,
* under 28 weeks of gestation,
* multiparous,
* with fetal anomaly,
* with risky pregnancy

Primary outcomes:
measure: Hospital Anxiety Depression Scale (HADS)
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Ondokuz Mayis University
state: Atakum
Study officials:
affiliation: Ondokuz Mayıs University
name: Emine KOÇ, Asst.Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Ondokuz Mayıs University
name: Nazlı BALTACI, Asst.Prof
role: STUDY_CHAIR
References:
citation: Ma X, Wang Y, Hu H, Tao XG, Zhang Y, Shi H. The impact of resilience on prenatal anxiety and depression among pregnant women in Shanghai. J Affect Disord. 2019 May 1;250:57-64. doi: 10.1016/j.jad.2019.02.058. Epub 2019 Feb 26.
citation: Gonzalez-Mesa E, Kabukcuoglu K, Korukcu O, Blasco M, Ibrahim N, Cazorla-Granados O, Kavas T. Correlates for state and trait anxiety in a multicultural sample of Turkish and Spanish women at first trimester of pregnancy. J Affect Disord. 2019 Apr 15;249:1-7. doi: 10.1016/j.jad.2019.01.036. Epub 2019 Jan 31.