Effectiveness of Early Parental Sensitivity Intervention for Preterm Infant Mothers

Attachment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05302700
• Other study ID #: Y_110_0501
• Status: Completed
• Phase: N/A
• Start date: November 2, 2022
• Est. completion date: November 22, 2023

Study information

• Verified date: March 2023
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: November 22, 2023
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Attachment
• Hypersensitivity
• Parental Stress

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Yang Ming Chiao Tung University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

Dunham MM, Marin T. NICU Maternal-Infant Bonding: Virtual Visitation as a Bonding Enhancement Tool. J Perinat Neonatal Nurs. 2020 Apr/Jun;34(2):171-177. doi: 10.1097/JPN.0000000000000484. — View Citation

Ioannou A, Papastavrou E, Avraamides MN, Charalambous A. Virtual Reality and Symptoms Management of Anxiety, Depression, Fatigue, and Pain: A Systematic Review. SAGE Open Nurs. 2020 Aug 27;6:2377960820936163. doi: 10.1177/2377960820936163. eCollection 2020 Jan-Dec. — View Citation

Kim AR, Kim SY, Yun JE. Attachment and relationship-based interventions for families during neonatal intensive care hospitalization: a study protocol for a systematic review and meta-analysis. Syst Rev. 2020 Mar 21;9(1):61. doi: 10.1186/s13643-020-01331-8. — View Citation

Lavallee A, Aita M, Bourbonnais A, De Clifford-Faugere G. Effectiveness of early interventions for parental sensitivity following preterm birth: a systematic review protocol. Syst Rev. 2017 Mar 23;6(1):62. doi: 10.1186/s13643-017-0459-x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal Attachment Inventory	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.	On the fifth to seventh day after birth of preterm infant.
Primary	Maternal Confidence Questionnaire	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.	On the fifth to seventh day after birth of preterm infant.
Primary	Parental Stressor Scale: Infant Hospitalization	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.	On the fifth to seventh day after birth of preterm infant.
Secondary	Maternal Attachment Inventory	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.	The first month of birth of preterm infant.
Secondary	Maternal Confidence Questionnaire	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.	The first month of birth of preterm infant.
Secondary	Parental Stressor Scale: Infant Hospitalization	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.	The first month of birth of preterm infant.