The Effect of Parental Participation on Newborn Comfort During Diaper Care

NCT ID: NCT06345742

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-19

Study Completion Date

2024-10-18

Brief Summary

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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.

Detailed Description

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The expectation of all parents is to have a healthy baby at the end of the pregnancy. However, newborns being born unexpectedly early and being admitted to the neonatal intensive care unit is a stressful situation for both newborns and parents. During this process, parents of preterm infants experience anxiety, loss of control, fear of the future, depression, role change and concerns about the improvement of the baby's condition. It is important for parents to actively participate in care within the framework of family-centered care practices in order to reduce the newborn's stress level, increase its comfort and improve its environment and to increase the families' ability to cope with this situation.Infant care, which is repeated many times a day in the Neonatal Intensive Care Unit, is one of the care practices that include tactile stimuli. Studies have observed that preterm infants' stress increases during diaper changes. For this reason, it is important to plan the necessary invasive practices to increase comfort during diaper changes, to include parental participation in these procedures, and to determine the effect of these interventions on the infants' comfort and to include them in the literature.

Conditions

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Preterm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Control group (no parental participation)

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

Group Type OTHER

No parental participation

Intervention Type 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.

Experimental group (mother participation)

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

Group Type EXPERIMENTAL

Mother participation

Intervention Type 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 (father participation)

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

Group Type EXPERIMENTAL

Father participation

Intervention Type 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.

Interventions

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No parental participation

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.

Intervention Type OTHER

Mother participation

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.

Intervention Type OTHER

Father participation

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Acibadem University

OTHER

Sponsor Role lead

Responsible Party

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Zehra Kan Onturk

Assist. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tuğba Turker, Nurse

Role: PRINCIPAL_INVESTIGATOR

Acibadem University

Locations

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Acıbadem University

Istanbul, Ataşehir, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 33559337 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 8506163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16507341 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31709208 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29595549 (View on PubMed)

Other Identifiers

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ATADEK-2023-10/396

Identifier Type: -

Identifier Source: org_study_id

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