Nursing Intervention for Knowledge and Self-care Behaviors in the Face of Hypertensive Disorders of Pregnancy

NCT ID: NCT05837962

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-10
• Study Completion Date: 2023-12-28

Brief Summary

Hypertensive disorders of pregnancy (HDP) are a leading cause of maternal and fetal morbidity and mortality worldwide. The lack of knowledge and self-care behaviors by the pregnant woman in the face of THE could be associated with their appearance. This is a randomized controlled pilot trial type study, with a control group that will receive the usual prenatal care and an intervention group that will additionally receive the nursing intervention to improve knowledge and self-care behaviors in the face of HDP. Each group will include 30 pregnant women, for a total of 60 users. The level of knowledge and self-care behaviors will be assessed before and after the intervention.

Detailed Description

Introduction: the World Health Organization (WHO) indicates that HDP are the third leading cause of maternal death worldwide; and in Latin America and the Caribbean they are positioned as the first cause. The evidence has described that limited or non-existent knowledge and the lack of self-care behaviors by the pregnant woman in the face of HDP are important conditions in the incidence of this obstetric complication. In this sense, nursing must design and implement intervention strategies that have a positive impact on knowledge and self-care behaviors in the face of HDP.

Objective: to determine the feasibility and acceptability of the "EducaTHE" nursing intervention to improve knowledge and self-care behaviors in the face of hypertensive disorders of pregnancy in pregnant women.

Methods: randomized controlled pilot trial experimental study with pregnant women assigned to an intervention group and a control group. The sample will consist of a total of 40 pregnant women, 20 in each of the study groups.

The intervention group will receive the usual education of prenatal control. The control group, in addition to the usual prenatal control information, will receive an educational, behavioral and motivational intervention related to HDP and their self-care behaviors. The intervention will be carried out in 4 sessions, on a weekly basis, in a face-to-face and group. In both groups, knowledge and self-care behaviors will be measured before and 4 weeks after the end of the intervention.

Randomization: the assignment will be carried out through a simple randomization process, with an intervention/control ratio 1:1, by means of a sequence of random numbers generated by a statistical program. The assignment will be given by one of the researchers who will not perform the intervention, nor the initial or final evaluation.

Expected results: feasibility and acceptability of the study in the context of perinatal maternal care

Conditions

Hypertensive Disorders of Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Nursing intervention to improve knowledge and self-care behaviors in the face of HDP

Behavioral: Educational, behavioral and motivational intervention developed by nurses aimed at improving the level of knowledge and self-care behaviors of pregnant women in the face of HDP.

Group Type: EXPERIMENTAL

Nursing intervention to improve knowledge and self-care behaviors in the face of HDP

Intervention Type: BEHAVIORAL

The nursing professional will perform 1 session weekly, for 4 weeks, lasting 90 minutes each. The contents that make up each of the sessions are:

Session 1. Knowledge about the risk factors, signs and symptoms, maternal and fetal complications of HDP.

Session 2. Control over behaviour, positive attitude and family and social support: essential components for conducting self-care behaviour.

Session 3. Nutritional recommendations: eating healthy helps prevent or reduce the risk of developing HDP.

Recommendations to improve sleep, rest and physical exercise: key routines in my health to prevent or reduce the risk of developing HDP.

Session 4. Mental health promotion: managing my stress, anxiety and depression levels help prevent or decrease the risk of HDP

Usual management during prenatal care

Behavioral: Nursing education about maternal care and usual education in maternity preparation course

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nursing intervention to improve knowledge and self-care behaviors in the face of HDP

The nursing professional will perform 1 session weekly, for 4 weeks, lasting 90 minutes each. The contents that make up each of the sessions are:

Session 1. Knowledge about the risk factors, signs and symptoms, maternal and fetal complications of HDP.

Session 2. Control over behaviour, positive attitude and family and social support: essential components for conducting self-care behaviour.

Session 3. Nutritional recommendations: eating healthy helps prevent or reduce the risk of developing HDP.

Recommendations to improve sleep, rest and physical exercise: key routines in my health to prevent or reduce the risk of developing HDP.

Session 4. Mental health promotion: managing my stress, anxiety and depression levels help prevent or decrease the risk of HDP

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Pregnant women enrolled in the prenatal care program of a health institution
• Pregnant women aged 18 years or older
• Pregnant women with a gestational age equal to or less than 24 weeks determined by the date of the last period or obstetric ultrasound.
• Pregnant women residing in the urban area.

Exclusion Criteria

• Pregnant women with chronic conditions such as heart disease, renal disease, or diabetes mellitus.
• Pregnant women with a history or diagnosis at entry or during the study of HDP according to the classification of the American College of Obstetricians and Gynecologists (ACOG)
• Pregnant women who are participating in other educational studies or workshops/programs with similar themes to this study.
• Pregnant women scoring less than 24 points on the Mini-mental status test.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Antioquia

OTHER

Sponsor Role: lead

Responsible Party

Edier Mauricio Arias Rojas

Profesor Facultad de Enfermería

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edier Arias Rojas

Role: STUDY_DIRECTOR

Universidad de Antioquia

Iliana Ulloa Sabogal

Role: PRINCIPAL_INVESTIGATOR

Universidad de Antioquia

Locations

Local Hospital of Piedecuesta

Santander, Piedecuesta, Colombia

Countries

Colombia

Other Identifiers

Acta No 234 CEI-FE

Identifier Type: -

Identifier Source: org_study_id