Effectiveness of Early Parental Sensitivity Intervention for Preterm Infant Mothers

NCT05302700 | Completed DMC

• 1 other identifier: Y_110_0501
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Attachment; Parental Stress

Keywords

preterm infant mothers; early; parental sensitivity intervention; attachment; parenting confidence; parental stress

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (3)

• Maternal Attachment Inventory

  The first month of birth of preterm infant.

• Maternal Confidence Questionnaire

  The first month of birth of preterm infant.

• Parental Stressor Scale: Infant Hospitalization

  The first month of birth of preterm infant.

Study Arms (2)

Early Parental Sensitivity Intervention Program

EXPERIMENTAL

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

Behavioral: Early Parental Sensitivity Intervention

Control group

NO INTERVENTION

The control group received general routine nursing guidance.

Interventions

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.

Early Parental Sensitivity Intervention Program

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Yang Ming Chiao Tung University: lead

Study Sites (1)

National Yang Ming Chiao Tung University

Taipei, 11221, Taiwan

Location

Related Publications (4)

• 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.

  PMID: 28335806 BACKGROUND

• 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.

  PMID: 32332447 BACKGROUND

• 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.

  PMID: 33415290 BACKGROUND

• 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.

  PMID: 32199458 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 31, 2022
• Study Start: November 2, 2022
• Primary Completion: September 20, 2023
• Study Completion: November 22, 2023
• Last Updated: April 9, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)