Effectiveness of Early Parental Sensitivity Intervention for Preterm Infant Mothers

Not Applicable

Completed

• Conditions: Parental Stress; Attachment
• Interventions: Behavioral: Early Parental Sensitivity Intervention

• Registration Number: NCT05302700
• Lead Sponsor: National Yang Ming Chiao Tung University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-03-15
• Study First Submitted QC: 2022-03-27
• Study First Posted: 2022-03-31
• Study Start: 2022-11-02
• Status Verified: 2023-03
• Primary Completion: 2023-09-20
• Study Completion: 2023-11-22
• Last Update Submitted: 2024-04-07
• Last Update Posted: 2024-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early Parental Sensitivity Intervention Program	Early Parental Sensitivity Intervention	The protocol will last five to seven days for preterm infant mothers.

Primary Outcome Measures

Name	Time	Method
Maternal Confidence Questionnaire	On the fifth to seventh day after birth of preterm infant.	Using the Maternal Confidence Questionnaire to measure parenting confidence.There are 14 items on the scale,each item was scored using a 5-point Likert scale.The total score ranges from 14 to 70, with higher scores indicating better parenting confidence.
Maternal Attachment Inventory	On the fifth to seventh day after birth of preterm infant.	Using the Maternal Attachment Inventory to measure mother-infant attachment.There are 22 items on the scale,each item was scored using a 4-point Likert scale.The total score ranges from 22 to 88, with higher scores indicating better attachment.
Parental Stressor Scale: Infant Hospitalization	On the fifth to seventh day after birth of preterm infant.	Using the Parental Stressor Scale: Infant Hospitalization to measure parental stress.There are 21 items on the scale,each item was scored using a 5-point Likert scale.The total score ranges from 21 to 105, with higher scores indicating greater stress.

Secondary Outcome Measures

Name	Time	Method
Maternal Attachment Inventory	The first month of birth of preterm infant.	Using the Maternal Attachment Inventory to measure mother-infant attachment.There are 22 items on the scale,each item was scored using a 4-point Likert scale.The total score ranges from 22 to 88, with higher scores indicating better attachment.
Maternal Confidence Questionnaire	The first month of birth of preterm infant.	Using the Maternal Confidence Questionnaire to measure parenting confidence.There are 14 items on the scale,each item was scored using a 5-point Likert scale.The total score ranges from 14 to 70, with higher scores indicating better parenting confidence.
Parental Stressor Scale: Infant Hospitalization	The first month of birth of preterm infant.	Using the Parental Stressor Scale: Infant Hospitalization to measure parental stress.There are 21 items on the scale,each item was scored using a 5-point Likert scale.The total score ranges from 21 to 105, with higher scores indicating greater stress.

Trial Locations

Locations (1)

National Yang Ming Chiao Tung University; 🇨🇳 Taipei, Taiwan