The Effect of Parental Participation on Newborn Comfort During Diaper Care

September 9, 2025 updated by: Zehra Kan Onturk, Acibadem University

The Effect of Parental Participation on Newborn Comfort During Diaper Care Practice in Preterm Infants

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Ataşehir
      • Istanbul, Ataşehir, Turkey (Türkiye), 34750
        • Acıbadem University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Control group (no parental participation)
In the control group, infant diaper care will be carried out without parental participation.
Other: 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.
Experimental: Experimental group (mother participation)
In the experimental group, infant diaper care will be provided with the mothers.
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.
Experimental: Experimental group (father participation)
In the experimental group, infant diaper care will be provided with the fathers.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of Parental Stress
Time Frame: It will be measured once just before the diaper care
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
Time Frame: immediately before the procedure, during the procedure, immediately after the procedure. The change in these time intervals will be assessed
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Investigators

  • Principal Investigator: Tuğba Turker, Nurse, Acibadem University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2023

Primary Completion (Actual)

October 18, 2024

Study Completion (Actual)

October 18, 2024

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

April 2, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 9, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATADEK-2023-10/396

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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