Home Support for Mothers Whose Premature Infants

NCT ID: NCT04741672

Last Updated: 2023-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-22

Study Completion Date

2022-08-01

Brief Summary

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Premature births are a challenging process for parents in many ways. Especially after the treatment and care in the hospital, they are concerned about whether they will be able to provide adequate care for their baby at home. The aim of this study is to examine the effect of the guide and telephone support given to mothers whose premature infants were discharged from the neonatal intensive care unit on the perceived maternal self-efficacy and state anxiety levels.

Detailed Description

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The study was planned as a randomized controlled trial with a single blind, pretest-posttest design. This study will be conducted between February 2021 and March 2022 with premature infants mothers. The sample of the study will be mothers (n = 102) of premature infants discharged from Antalya Training and Research Hospital Neonatal Intensive Care Unit. 51 mothers participating in the study will be given a premature infant home care guide after the discharge routine procedures are completed. In addition, mothers will be given an appointment for a phone call a week later. No intervention will be applied to the other 51 mothers after their discharge routine. Data will be collected by Mother-Infant Descriptive Information Form, Perceived Maternity Self-Efficacy Scale (PMSES), State Anxiety Inventory (SAI). Data will be collected with forms and scales immediately after discharge (pre-test) and in the 4th week after discharge (post-test). Ethics Committee and Institutional Permission was obtained for the study. In addition, written consent will be obtained from the participants. Statistical analysis will be done using SPSS 23.0 and significance will be evaluated at p \<0.05. Support will be received in the analysis phase of the Statistical Information Unit of Akdeniz University. It is predicted that the new information obtained from the research data will guide the education of premature infant mothers and new researches.

Conditions

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Infant, Premature, Diseases Mothers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This was pretest-posttest design, randomized controlled trial.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
The control and intervention group will be formed by randomization. The intervention and control group will be defined as group 1 and group 2 for statistical analysis. Data analysis will be evaluated and reported by the statistician. Also the statistician will be blind.

Study Groups

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Intervention group

Providing guidance and calling after discharge routine procedure.

Group Type EXPERIMENTAL

Providing guidance after discharge routine procedure and calling one week after discharge.

Intervention Type BEHAVIORAL

Guidance will be given to mothers after routine discharge. After one week, she will be called by phone and her questions about infant care will be answered.

Discharge routine procedure.

Intervention Type BEHAVIORAL

Discharge routine procedure.

Control group

Discharge routine procedure.

Group Type EXPERIMENTAL

Discharge routine procedure.

Intervention Type BEHAVIORAL

Discharge routine procedure.

Interventions

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Providing guidance after discharge routine procedure and calling one week after discharge.

Guidance will be given to mothers after routine discharge. After one week, she will be called by phone and her questions about infant care will be answered.

Intervention Type BEHAVIORAL

Discharge routine procedure.

Discharge routine procedure.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* The infant was born prematurely (37 weeks of gestation + 6 days earlier),
* Does not have advanced congenital anomalies in the baby,
* Who will carry out the primary care of the infant at home,
* Reading and writing,
* Can speak and understand Turkish,
* Mothers who agreed to participate in the study

Exclusion Criteria

* Incomplete filling of the forms
* Mothers who previously had training in newborn care
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Arzu Akcan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Arzu Akcan, PhD

Role: STUDY_DIRECTOR

Akdeniz Universtiy

Ezgi Boz, Postgraduate

Role: STUDY_CHAIR

Akdeniz University

Locations

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Akdeniz University

Antalya, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Lee SY, Chau JPC, Choi KC, Lo SHS. Feasibility of a guided participation discharge program for very preterm infants in a neonatal intensive care unit: a randomized controlled trial. BMC Pediatr. 2019 Nov 4;19(1):402. doi: 10.1186/s12887-019-1794-y.

Reference Type BACKGROUND
PMID: 31684903 (View on PubMed)

Other Identifiers

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19113

Identifier Type: -

Identifier Source: org_study_id

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