Effectiveness of Early Parental Sensitivity Intervention for Preterm Infant Mothers

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

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-02

Study Completion Date

2023-11-22

Brief Summary

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In Taiwan, according to the birth notification statistics of the Ministry of Health and Welfare. 164,496 newborns were born in 2020, with preterm births accounting for about 11.58%.Most preterm infants need to be hospitalized for highly specialized care, resulting in the separation of preterm infants from their parents after birth, which may have a negative impact on the healthy attachment development between parents and preterm infants. Moreover, due to the vulnerability of preterm infants, parents often lack the confidence to take care of them.

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Detailed Description

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The study was a quantitative study of a randomized controlled trial, designed by experimental research method. Using GPower 3.1.2 to estimate the number of samples, and the statistical method chosen was Repeated measures ANOVA, the sample size was 80.

The subjects were divided into two groups, The control group received general routine nursing guidance, while the experimental group received general routine nursing guidance and early parental sensitivity intervention program. Using the NICU VR Tour and Premature Infant Behavioral Clues Teaching Materials as educational tools for early parental sensitivity intervention program. The outcome used the Maternal Attachment Inventory, Maternal Confidence Questionnaire and Parental Stressor Scale: Infant Hospitalization as evaluated tools.

Conditions

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Attachment Parental Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Early Parental Sensitivity Intervention Program

The protocol will last five to seven days for preterm infant mothers.

Group Type EXPERIMENTAL

Early Parental Sensitivity Intervention

Intervention Type BEHAVIORAL

Parental sensitivity intervention include (1)Establish an emotional connection：Using the VR tour to introduce the environment, instruments and equipment of the neonatal intensive care unit, appearance of premature infants and pipeline wires on their bodies .(2)maintain physical proximity:proactively provide mothers with the opportunity to touch the body of preterm infants.(3) parents must understand their infant's cues:Using the Premature Infant Behavioral Clues Teaching Materials to play video and we will discuss and respond to the mother's questions.(4)engage in his/her care and communicate appropriately with him/her:We will discuss the behavioral clues of the preterm infant with the mother next to the incubator, encourage the mother to ask questions and participate in care activities such as changing diapers and stamping the baby's footprints on the card, asking the mother to write down the number of days of birth, corrected age, weight and what she wants to say for her baby.

Control group

The control group received general routine nursing guidance.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Early Parental Sensitivity Intervention

Parental sensitivity intervention include (1)Establish an emotional connection：Using the VR tour to introduce the environment, instruments and equipment of the neonatal intensive care unit, appearance of premature infants and pipeline wires on their bodies .(2)maintain physical proximity:proactively provide mothers with the opportunity to touch the body of preterm infants.(3) parents must understand their infant's cues:Using the Premature Infant Behavioral Clues Teaching Materials to play video and we will discuss and respond to the mother's questions.(4)engage in his/her care and communicate appropriately with him/her:We will discuss the behavioral clues of the preterm infant with the mother next to the incubator, encourage the mother to ask questions and participate in care activities such as changing diapers and stamping the baby's footprints on the card, asking the mother to write down the number of days of birth, corrected age, weight and what she wants to say for her baby.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Preterm infants:

1. Preterm infants less than 37 weeks gestation and hospitalized in the NICU
2. The birth weight is classified as VLBW and LBW, and the birth weight is between 1,000-2,499gm
2. Preterm infant mothers:

1. Children have not been hospitalized in the NICU in the past
2. At least 20 years old
3. They can speak Chinese, Taiwanese fluently and need to be literate

Exclusion Criteria

1. Preterm infants :

1. Combined congenital diseases and chromosomal abnormalities
2. Immediate surgery, first aid and unstable vital signs are necessary after birth
3. The birth weight is classified as ELBW, and the birth weight is less than 1,000gm
2. Preterm infant mothers:

1. Hospitalized in the intensive care unit

Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No