The Effect of Parental Participation on Newborn Comfort During Diaper Care

NCT06345742 | Completed

• 1 other identifier: ATADEK-2023-10/396
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

It was aimed to determine the effect of parental participation on newborn comfort during diaper care practice in preterm infants. H1: Parental participation during infant diaper care practice in preterm infants has an effect on newborn comfort. H2: There is a difference in the effect of parent diaper care practice and the participation of the mother or father on newborn comfort in preterm infants. H3: There is a difference between the stress levels of parents before the application of infant diaper care in preterm infants.

Conditions

Preterm

Keywords

diaper care; newborn comfort; parental participation; preterm

Outcome Measures

Primary Outcomes (2)

• Level of Parental Stress

  The level of parental stress will be measured using the Neonatal Intensive Care Unit Parental Stress Scale.The scale was developed by Miles, Funk and Carlson in 1993 to determine the perception levels of stressors arising from the physical and psychosocial environment by mothers and fathers. The Turkish validity and reliability study of the scale was conducted by Turan and Başbakkal in 2006. The scale consists of 5 rating points and is rated from 1 (not stressful) to 5 (extremely stressful). The score that can be obtained from the scale varies between 0 and 170. The scale can be applied to mothers and fathers with infants in the neonatal intensive care unit

  It will be measured once just before the diaper care

• Change in Level of Comfort

  The infants' comfort level will be measured using the Premature Infant Comfort Scale.The scale is a multi-dimensional scale used to measure comfort in preterm newborns. The Premature Infant Comfort Scale was developed by Monique et al. in the Netherlands in 2007. The validity and reliability of the Turkish scale was determined by Küçük Alemdar and Güdücü Tüfekçi in 2015. The scale consists of 1 to 5 rating points. The infant's comfort is evaluated based on the total score according to the scale. According to the total score, 35 indicates the lowest score, 7 indicates the highest comfort level, and a high score indicates a low comfort level. The subscales of the scale include the preterm infant's alertness, calmness, respiratory status, physical movement, muscle tone, facial movements, and average heart rate

  immediately before the procedure, during the procedure, immediately after the procedure. The change in these time intervals will be assessed

Study Arms (3)

Control group (no parental participation)

OTHER

In the control group, infant diaper care will be carried out without parental participation.

Other: No parental participation

Experimental group (mother participation)

EXPERIMENTAL

In the experimental group, infant diaper care will be provided with the mothers.

Other: Mother participation

Experimental group (father participation)

EXPERIMENTAL

In the experimental group, infant diaper care will be provided with the fathers.

Other: Father participation

Interventions

No parental participation OTHER

1. Before collecting data, Preterm Infant information form will be filled out. 2. The "Premature Infant Comfort Scale" will be evaluated before the procedure. 3. Diaper care will be performed by the primary nurse. 4. "Premature Infant Comfort Scale" will be evaluated during and after the diaper care application.

Control group (no parental participation)

Mother participation OTHER

1. Before collecting data, Preterm Infant information form will be filled out. 2. The "Premature Infant Comfort Scale" will be evaluated before the procedure. 3. Mothers' stress level will be determined using the "Neonatal Intensive Care Unit Parent Stress Scale" 4. Mothers will be given practical diaper care training on the infant model doll. 5. Diaper care will be provided by the mothers of the infants 6. "Premature Infant Comfort Scale" will be evaluated during and after the application.

Experimental group (mother participation)

Father participation OTHER

1. Before collecting data, Preterm Infant information form will be filled out. 2. The "Premature Infant Comfort Scale" will be evaluated before the procedure. 3. Fathers' stress level will be determined using the "Neonatal Intensive Care Unit Parent Stress Scale" 4. Fathers will be given practical diaper care training on the infant model doll. 5. Diaper care will be provided by the fathers of the infants 6. "Premature Infant Comfort Scale" will be evaluated during and after the application.

Experimental group (father participation)

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants whose gestational age is between ≥34 weeks and ≤36+6 weeks at the time of application
• Infants with stable health conditions

You may not qualify if:

• Intubated
• Those with very low and extremely low birth weight at the time of procedure
• Having a chronic disease
• Those with congenital anomalies
• Having undergone a surgical procedure
• Having neurological symptoms
• Receiving oxygen support
• Diagnosed with sepsis
• Sedated
• A pharmacological analgesic method was used four hours before.
• Parents who do not want to participate in care

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acıbadem University

Istanbul, Ataşehir, 34750, Turkey (Türkiye)

Location

Related Publications (5)

• Girabent-Farres M, Jimenez-Gonzalez A, Romero-Galisteo RP, Amor-Barbosa M, Bagur-Calafat C. Effects of early intervention on parenting stress after preterm birth: A meta-analysis. Child Care Health Dev. 2021 May;47(3):400-410. doi: 10.1111/cch.12853. Epub 2021 Feb 15.

  PMID: 33559337 BACKGROUND

• Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.

  PMID: 8506163 BACKGROUND

• Morelius E, Hellstrom-Westas L, Carlen C, Norman E, Nelson N. Is a nappy change stressful to neonates? Early Hum Dev. 2006 Oct;82(10):669-76. doi: 10.1016/j.earlhumdev.2005.12.013. Epub 2006 Feb 28.

  PMID: 16507341 BACKGROUND

• Pichler-Stachl E, Urlesberger P, Mattersberger C, Baik-Schneditz N, Schwaberger B, Urlesberger B, Pichler G. Parental Stress Experience and Age of Mothers and Fathers After Preterm Birth and Admission of Their Neonate to Neonatal Intensive Care Unit; A Prospective Observational Pilot Study. Front Pediatr. 2019 Oct 24;7:439. doi: 10.3389/fped.2019.00439. eCollection 2019.

  PMID: 31709208 BACKGROUND

• Prouhet PM, Gregory MR, Russell CL, Yaeger LH. Fathers' Stress in the Neonatal Intensive Care Unit: A Systematic Review. Adv Neonatal Care. 2018 Apr;18(2):105-120. doi: 10.1097/ANC.0000000000000472.

  PMID: 29595549 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Tuğba Turker, Nurse

  Acibadem University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof.

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 3, 2024
• Study Start: December 19, 2023
• Primary Completion: October 18, 2024
• Study Completion: October 18, 2024
• Last Updated: September 15, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)