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Completed

NCT Number: NCT04109651

The Effect of Nursing Interventions on Maternal Attachment, Parental Self-efficacy and Infant Development

The aim of this study was to determine the effects of Meleis 'Transition Theory based health improvement monitoring program on infants' development, maternal attachment and parental self-efficacy in 36-40 weeks of gestation and in the first and fourth months after birth. Sample was 64 (experimental group:32; control group: 32), alfa=0,05 and power=0.80 at the end of study. The experimental group received nursing interventions based on Meleis' Transition Theory, while the control group received routine primary health care. Data were collected 3 times: pretest, 3 and 7 months after intervention (for experimental group) and 3 and 7 months after pretest (for control group).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kto Karatay University

Konya, Turkey (Türkiye)

About this study

Motherhood is one of the most important milestones in a woman's life, and at the same time the beginning of a process in which very important responsibilities are undertaken. The mother needs knowledge, skills and energy to fulfill her new responsibilities. The development of motherhood identity is the process of learning motherhood behaviors of women. This process starts with the recognition of pregnancy, develops during pregnancy and continues after birth. Transition Theory is a suitable tool for nurses to understand the transition to parenting, a developmental type of transition. Appropriate nursing interventions tailored to the needs of pregnant women and women who have just given birth are needed. Targeted / predicted change in the large / large effect size of the mothers in the experimental group (effect size 0.80, 80% of the standard deviation) with the Health Promotion Monitoring Program, the sample calculation with 5% alpha error and 80% power was the minimum for each group. It was determined that a total of 52 people (26 *) should be recruited (G * Power 3.1.9.2). It was decided to include at least 32 people in each working group with a 20% surplus, considering that they might be lost in data collection. Women's experiences in transition to motherhood should be sought to propose, define, and explain professional interventions. In this study, a Health Promotion Program starting from 36-40 weeks of gestation until the sixth month of birth was administered to the mothers registered at the primary health care center in Karatay, Konya. In this study, the investigator planned to increase maternal infant attachment, to increase parental self-efficacy, to keep infant development at the best level, thus ensuring a healthy transition for the mother.

Duration of intervention and collecting data for the study was 11 months. Data was collected using information form (21 item; information about participant, parents and infant), three scales (Turkish Version of Maternal Attachment Inventory; parental self-efficacy scale, Denver II development screening test). Scales validation and reliability studies were made for Turkish population.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having at least primary school graduation
  • 18 Years and older
  • Lack of any chronic disease

Exclusion criteria

  • Multiple pregnancy
  • Risk of preterm birth
  • Does not speak Turkish
  • Pregnant / mothers not attending at least one education and / or measurement
  • Want to leave the work
  • Presence of mental or physical illnesses such as postpartum depression during follow-up
  • Baby; Presence of congenital and / or metabolic disease during prenatal and postnatal postnatal follow-up

Treatment and study plan

Nursing Intervention

Other

Nursing Intervention: This intervention was planned based on Meleis' Transition Theory. So it includes individual counseling and training.

In the Health Promotion Monitoring Program; three training modules and one reminder module were implemented and telephone counseling was provided. Various training tools were used in these trainings. Three different power point presentations were made during the training sessions. Illustrated printed training material was used. At the end of the training, training booklet was given to the participants.

Other names: No Intervention: Control Group

Primary outcomes

  1. infant development level

    Time frame: At the end of 7 month

    infant development at a high level

Secondary outcomes

  1. Maternal attachment scores

    Time frame: At the end of 7 month

    Mother will increase infant attachment level

  2. Parental self-efficacy scales scores

    Time frame: At the end of 7 month

    Mother self-efficacy level will increase

Sponsors and collaborators

Lead sponsor

KTO Karatay University

Other

Registry information

Official study title

Influence of Nursing Intervention on Mother and Infant, Materna Attachment, Parental Self-efficacy, Infant Development

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 30, 2019
Registry last updated
Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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