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Effectiveness of Early Parental Sensitivity Intervention for Preterm Infant Mothers

N

National Yang Ming Chiao Tung University

Status

Completed

Conditions

Attachment
Parental Stress

Treatments

Behavioral: Early Parental Sensitivity Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05302700
Y_110_0501

Details and patient eligibility

About

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.

Full description

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.

Enrollment

68 patients

Sex

Female

Ages

20 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

68 participants in 2 patient groups

Early Parental Sensitivity Intervention Program
Experimental group
Description:
The protocol will last five to seven days for preterm infant mothers.
Treatment:
Behavioral: Early Parental Sensitivity Intervention
Control group
No Intervention group
Description:
The control group received general routine nursing guidance.

Trial contacts and locations

1

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Central trial contact

Chi-Wen Chen, PhD; Ting-Yi Hsu, MD

Data sourced from clinicaltrials.gov

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