Clinical trial NCT04109651: The Effect of Nursing Interventions on Maternal Attachment, Parental Self-efficacy and Infant Development
Official title: Influence of Nursing Intervention on Mother and Infant, Materna Attachment, Parental Self-efficacy, Infant Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurse's Role
Parenting
Self Efficacy
Development, Child
Attachment
Lead sponsor: KTO Karatay University
Sponsor class: OTHER
First posted: 2019-09-30
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional (Clinical Trial)
Primary purpose: OTHER

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: infant development level
timeFrame: At the end of 7 month
Secondary outcomes:
measure: Maternal attachment scores
timeFrame: At the end of 7 month
measure: Parental self-efficacy scales scores
timeFrame: At the end of 7 month
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Kto Karatay University
Study officials:
affiliation: SELÇUK UNİVERSİTY
name: FATMA TAŞ ARSLAN
role: STUDY_DIRECTOR
References: