Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04109651
Other study ID # KaratayU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 3, 2018
Est. completion date August 12, 2019

Study information

Verified date September 2019
Source KTO Karatay University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date August 12, 2019
Est. primary completion date August 12, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
Nursing intervention
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.

Locations

Country Name City State
Turkey Kto Karatay University Konya

Sponsors (1)

Lead Sponsor Collaborator
KTO Karatay University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary infant development level infant development at a high level At the end of 7 month
Secondary Maternal attachment scores Mother will increase infant attachment level At the end of 7 month
Secondary Parental self-efficacy scales scores Mother self-efficacy level will increase At the end of 7 month
See also
  Status Clinical Trial Phase
Completed NCT03905278 - Parental Support Intervention in the Oncological Context N/A
Recruiting NCT06111040 - Nurturing Needs Study: Parenting Food Motivated Children N/A
Completed NCT03559907 - Partnering for Prevention: Building Healthy Habits in Underserved Communities N/A
Completed NCT04628546 - The Parenting Young Children Check-up Evaluation N/A
Recruiting NCT06273228 - Parenting Young Children in Pediatrics N/A
Terminated NCT03517111 - The Impact of a Parenting Intervention on Latino Youth Health Behaviors N/A
Completed NCT04502979 - Learning to Love Mealtime Together N/A
Completed NCT03097991 - Randomized Controlled Trial of Prenatal Coparenting Intervention (CoparentRCT) N/A
Recruiting NCT06038721 - Unified Protocol: Community Connections N/A
Completed NCT04556331 - Sowing the Seeds of Confidence: Brief Online Group Parenting Programme for Anxious Parents of 1-3 Year Olds N/A
Completed NCT04101799 - Evaluation of the Parental Support Intervention For Our Children's Sake in Prisons in Sweden N/A
Completed NCT02792309 - Impact Evaluation of MotherWise Program N/A
Recruiting NCT02622048 - Understanding and Helping Families: Parents With Psychosis N/A
Completed NCT02718508 - An e-Parenting Skills Intervention to Decrease Injured Adolescents' Alcohol Use N/A
Completed NCT01861158 - Online Parent Training for Children With Behavior Disorders N/A
Completed NCT01554215 - Mom Power is an Attachment Based Parenting Program for Families and Their Children Phase 2
Terminated NCT01395238 - Enhancing Father's Ability to Support Their Preschool Child N/A
Completed NCT05930535 - Family-Focused Adolescent & Lifelong Health Promotion N/A
Completed NCT04525703 - Pathways for Parents After Incarceration Feasibility Study N/A
Recruiting NCT06038799 - Caregiver Skills Training: Comparing Clinician Training Methods N/A