Nulliparous Women and Education and Counseling

NCT05214846 | Completed

• 1 other identifier: 2020/737
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pregnancy

Keywords

nulliparous momen

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Education and Counseling

EXPERIMENTAL

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.

Behavioral: Education and counseling

control group

NO INTERVENTION

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

Interventions

Education and counseling 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.

Education and Counseling

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis University

Samsun, Atakum, 55200, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 30831542 BACKGROUND

• 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.

  PMID: 30739036 BACKGROUND

MeSH Terms

Interventions

Educational Status; Counseling

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Emine KOÇ, Asst.Prof

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

• Nazlı BALTACI, Asst.Prof

  Ondokuz Mayıs University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Dr.

Model Details: 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.

Study Record Dates

• First Submitted: January 17, 2022
• First Posted: January 31, 2022
• Study Start: January 25, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 5, 2022
• Last Updated: February 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)