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

Sponsor
National Yang Ming University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05302700
Collaborator
(none)
80
1
2
6
13.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Early Parental Sensitivity Intervention
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
The Effectiveness of Early Parental Sensitivity Intervention on Attachment, Parenting Confidence and Parental Stress of Preterm Infant Mothers
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Early Parental Sensitivity Intervention Program

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

Behavioral: 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.

No Intervention: Control group

The control group received general routine nursing guidance.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Preterm infants:

  2. Preterm infants less than 37 weeks gestation and hospitalized in the NICU

  3. The birth weight is classified as VLBW and LBW, and the birth weight is between 1,000-2,499gm

  4. Preterm infant mothers:

  5. Children have not been hospitalized in the NICU in the past

  6. At least 20 years old

  7. They can speak Chinese, Taiwanese fluently and need to be literate

Exclusion Criteria:
  1. Preterm infants :

  2. Combined congenital diseases and chromosomal abnormalities

  3. Immediate surgery, first aid and unstable vital signs are necessary after birth

  4. The birth weight is classified as ELBW, and the birth weight is less than 1,000gm

  5. Preterm infant mothers:

  6. Hospitalized in the intensive care unit

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Yang Ming Chiao Tung University Taipei Taiwan 11221

Sponsors and Collaborators

  • National Yang Ming University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
National Yang Ming University
ClinicalTrials.gov Identifier:
NCT05302700
Other Study ID Numbers:
  • Y_110_0501
First Posted:
Mar 31, 2022
Last Update Posted:
Apr 14, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Yang Ming University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 14, 2022