The Effect of Parental Participation on Newborn Comfort During Diaper Care
NCT ID: NCT06345742
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
105 participants
INTERVENTIONAL
2023-12-19
2024-10-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Half Swaddling Application on Infant Sleep Routine, Maternal Sleep Quality, Depression
NCT06750796
Effectiveness of Bonding-Based Education Intervention
NCT06186453
Effect of Immersion Bathing and Showering Applications on Comfort Level and Physiological Parameters of Newborn
NCT04811742
The Effect of Fathers' Birth Experience on Paternal Attachment and Parenting Perception: Randomized Controlled Trial
NCT06062667
The Effect of Kangaroo Care on Parents' Perceived Parenting Self-Efficacy, Infant Attachment and Newborn Vital Signs
NCT06320587
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control group (no parental participation)
In the control group, infant diaper care will be carried out without parental participation.
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 group (mother participation)
In the experimental group, infant diaper care will be provided with the mothers.
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 group (father participation)
In the experimental group, infant diaper care will be provided with the fathers.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Infants with stable health conditions
Exclusion Criteria
* 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
1 Day
28 Days
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Acibadem University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zehra Kan Onturk
Assist. Prof.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Tuğba Turker, Nurse
Role: PRINCIPAL_INVESTIGATOR
Acibadem University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Acıbadem University
Istanbul, Ataşehir, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ATADEK-2023-10/396
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.