NCT04109651

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 25, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2019

Completed
Last Updated

September 30, 2019

Status Verified

September 1, 2019

Enrollment Period

10 months

First QC Date

September 25, 2019

Last Update Submit

September 26, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • infant development level

    infant development at a high level

    At the end of 7 month

Secondary Outcomes (2)

  • Maternal attachment scores

    At the end of 7 month

  • Parental self-efficacy scales scores

    At the end of 7 month

Study Arms (2)

Nursing İntervention

EXPERIMENTAL

Intervention: Other: Nursing intervention

Other: Nursing intervention

No Intervention: Control Group

OTHER

Receive routine nursing care

Other: Nursing intervention

Interventions

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.

Also known as: No Intervention: Control Group
No Intervention: Control GroupNursing İntervention

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kto Karatay University

Konya, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Methods

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • FATMA TAŞ ARSLAN

    SELÇUK UNİVERSİTY

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The last data were collected nurses from primary health center (not researher) who did not know anything about participants of experiment and control group. Data recorded on the computer by the assistant investigator without specifying the experiment and control group. The experimental and control groups codified by the co-investigator. The analysis of the data encoded by the groups was done by a statistical expert. Data collectors, statistical analyzes and report writing were blinded.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Interventional (Clinical Trial)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching a-Assistant

Study Record Dates

First Submitted

September 25, 2019

First Posted

September 30, 2019

Study Start

October 3, 2018

Primary Completion

August 12, 2019

Study Completion

August 12, 2019

Last Updated

September 30, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

I do not plan to share any data of participants.

Locations