Nulliparous Women and Education and Counseling

NCT ID: NCT05214846

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-25
• Study Completion Date: 2022-01-05

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.

Conditions

Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Education and counseling

Intervention Type: BEHAVIORAL

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.

control group

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 control group was called by phone at the end of 6 weeks and told that they would be retested and 6 weeks later, they were called by phone and their anxiety and depression levels (posttest) were applied. directed to continue

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

Sümeyye BAL

Lecturer Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emine KOÇ, Asst.Prof

Role: PRINCIPAL_INVESTIGATOR

Ondokuz Mayıs University

Nazlı BALTACI, Asst.Prof

Role: STUDY_CHAIR

Ondokuz Mayıs University

Locations

Ondokuz Mayis University

Samsun, Atakum, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 30831542 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30739036 (View on PubMed)

Other Identifiers

2020/737

Identifier Type: -

Identifier Source: org_study_id