Clinical trial NCT05302700: Effectiveness of Early Parental Sensitivity Intervention for Preterm Infant Mothers
Official title: The Effectiveness of Early Parental Sensitivity Intervention on Attachment, Parenting Confidence and Parental Stress of Preterm Infant Mothers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attachment
Parental Stress
Keywords: preterm infant mothers
early
parental sensitivity intervention
attachment
parenting confidence
parental stress
Lead sponsor: National Yang Ming Chiao Tung University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 68
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Maternal Attachment Inventory
timeFrame: On the fifth to seventh day after birth of preterm infant.
measure: Maternal Confidence Questionnaire
timeFrame: On the fifth to seventh day after birth of preterm infant.
measure: Parental Stressor Scale: Infant Hospitalization
timeFrame: On the fifth to seventh day after birth of preterm infant.
Secondary outcomes:
measure: Maternal Attachment Inventory
timeFrame: The first month of birth of preterm infant.
measure: Maternal Confidence Questionnaire
timeFrame: The first month of birth of preterm infant.
measure: Parental Stressor Scale: Infant Hospitalization
timeFrame: The first month of birth of preterm infant.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Yang Ming Chiao Tung University
Study officials:
References:
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.
citation: 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.
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.
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.