Nulliparous Women and Education and Counseling

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Behavioral: Education and counseling

• Registration Number: NCT05214846
• Lead Sponsor: Ondokuz Mayıs University

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.

Study Timeline

• Study Start: 2021-01-25
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-05
• Study First Submitted: 2022-01-17
• Study First Submitted QC: 2022-01-17
• Study First Posted: 2022-01-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Education and Counseling	Education and counseling	After obtaining written 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 applied, the nurse gave individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. Women were counseled for 6 weeks. Anxiety-depression levels (post-test) were applied by phone call 6 weeks later.This education consisted of the definition and the purpose of pregnancy and pregnancy problems and nutrition during pregnancy, sexuality during pregnancy, number of fetal movements, preparation of the delivery bag, breast care, etc.

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety Depression Scale (HADS)	30 minutes	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).

Trial Locations

Locations (1)

Ondokuz Mayis University; 🇹🇷 Samsun, Atakum, Turkey