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Completed

NCT Number: NCT05302700

Effectiveness of Early Parental Sensitivity Intervention for Preterm Infant Mothers

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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Key information

Conditions

Attachment Parental Stress

Age range

20 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Yang Ming Chiao Tung University

Taipei, 11221, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Preterm infants:
  • Preterm infants less than 37 weeks gestation and hospitalized in the NICU
  • The birth weight is classified as VLBW and LBW, and the birth weight is between 1,000-2,499gm
  • Preterm infant mothers:
  • Children have not been hospitalized in the NICU in the past
  • At least 20 years old
  • They can speak Chinese, Taiwanese fluently and need to be literate

Exclusion criteria

  • Preterm infants :
  • Combined congenital diseases and chromosomal abnormalities
  • Immediate surgery, first aid and unstable vital signs are necessary after birth
  • The birth weight is classified as ELBW, and the birth weight is less than 1,000gm
  • Preterm infant mothers:
  • Hospitalized in the intensive care unit

Treatment and study plan

Early Parental Sensitivity Intervention

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.

Primary outcomes

  1. Maternal Attachment Inventory

    Time frame: 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.

  2. Maternal Confidence Questionnaire

    Time frame: 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.

  3. Parental Stressor Scale: Infant Hospitalization

    Time frame: 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 outcomes

  1. Maternal Attachment Inventory

    Time frame: 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.

  2. Maternal Confidence Questionnaire

    Time frame: 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.

  3. Parental Stressor Scale: Infant Hospitalization

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Yang Ming Chiao Tung University

Other

Registry information

Official study title

The Effectiveness of Early Parental Sensitivity Intervention on Attachment, Parenting Confidence and Parental Stress of Preterm Infant Mothers

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 31, 2022
Registry last updated
Apr 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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