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

NCT05837962 | Completed DMC

• 1 other identifier: Acta No 234 CEI-FE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertensive Disorders of Pregnancy

Keywords

Knowledge,Self Care,Pregnancy,Nursing, Feasibility Studies

Outcome Measures

Primary Outcomes (2)

• Feasibility: recruitment, attrition, follow-up

  Recruitment For the analysis of this variable, the number of pregnant women enrolled in the prenatal control program of the health institution who meet the inclusion criteria of the study, and the number of pregnant women who agree to participate in the study, will be taken into account. Attrition This variable will include the number of pregnant women who agreed to participate, and the number of participants who did not attend or did not complete the four sessions of the intervention. Follow-up This variable will include the number of pregnant women who complete the four sessions of the intervention, and the number of participants who completed the study after the post-intervention measurements.

  6 months

• Acceptability

  A survey will be used to assess acceptability. The survey will be divided into three sessions, the first consisting of 13 items aimed at obtaining information related to the contents of the educational material, the activities and the form of delivery of the intervention, dose and interventionist. The second session consisted of 11 items that will evaluate the benefits and weaknesses of the intervention. The third contains 3 open questions related to the taste for the intervention, suggestions and recommendations

  6 months

Study Arms (2)

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

EXPERIMENTAL

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.

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

Usual management during prenatal care

NO INTERVENTION

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

Interventions

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

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Antioquia: lead

Study Sites (1)

Local Hospital of Piedecuesta

Santander, Piedecuesta, 681011, Colombia

Location

Study Officials

• Edier Arias Rojas

  Universidad de Antioquia

  STUDY DIRECTOR

• Iliana Ulloa Sabogal

  Universidad de Antioquia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor Facultad de Enfermería

Study Record Dates

• First Submitted: April 2, 2023
• First Posted: May 1, 2023
• Study Start: April 10, 2023
• Primary Completion: August 16, 2023
• Study Completion: December 28, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

CO (1)