Nulliparous Women and Education and Counseling

Pregnancy Clinical Trial

Official title:

The Effect of Education and Counseling on Reducing Anxiety and Depression in Nullipar Pregnancy Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05214846
• Other study ID #: 2020/737
• Status: Completed
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: January 5, 2022

Study information

• Verified date: February 2022
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 5, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Behavioral:
• Education and counseling
After obtaining informed consent, the data collection form, Hospital Anxiety Depression Scale (HADS) was applied to both groups by face to face interview. Immediately after the questionnaires were answered, individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. In addition, the education and counseling given to the participants by the researcher.The experimental group was given a telephone number where they could receive consultancy services for 12 hours a day. Pre-test was applied. One day later, the pregnant woman was called and encouraged to call for all her questions, and she was informed that she would be returned when she called.

Locations

Country	Name	City	State
Turkey	Ondokuz Mayis University	Samsun	Atakum

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

González-Mesa E, Kabukcuoglu K, Körükcü 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Anxiety Depression Scale (HADS)	The HADS contains 14 items and consists of two subscales: anxiety and depression. Each item is rated on a four-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represents 'borderline' and 0-7 'normal' (Zigmont ve Snaith).	30 minutes