PretermNCT06345742
The Effect of Parental Participation on Newborn Comfort During Diaper Care
A study testing No parental participation, Mother participation and Father participation in people with Preterm, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Preterm
- What is being tested?
- No parental participation, Mother participation and Father participation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Dec 2023to 18 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants whose gestational age is between ≥34 weeks and ≤36+6 weeks at the time of application
- Infants with stable health conditions
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Preterm
- Being tested
- No parental participation, Mother participation, Father participation
- Keywords
- diaper care, newborn comfort, parental participation, preterm
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No parental participationOther
- Before collecting data, Preterm Infant information form will be filled out.
- The "Premature Infant Comfort Scale" will be evaluated before the procedure.
- Diaper care will be performed by the primary nurse.
- "Premature Infant Comfort Scale" will be evaluated during and after the diaper care application.
Mother participationOther
- Before collecting data, Preterm Infant information form will be filled out.
- The "Premature Infant Comfort Scale" will be evaluated before the procedure.
- Mothers' stress level will be determined using the "Neonatal Intensive Care Unit Parent Stress Scale"
- Mothers will be given practical diaper care training on the infant model doll.
- Diaper care will be provided by the mothers of the infants
- "Premature Infant Comfort Scale" will be evaluated during and after the application.
Father participationOther
- Before collecting data, Preterm Infant information form will be filled out.
- The "Premature Infant Comfort Scale" will be evaluated before the procedure.
- Fathers' stress level will be determined using the "Neonatal Intensive Care Unit Parent Stress Scale"
- Fathers will be given practical diaper care training on the infant model doll.
- Diaper care will be provided by the fathers of the infants
- "Premature Infant Comfort Scale" will be evaluated during and after the application.
| Study group | Role | What they receive |
|---|---|---|
| Control group (no parental participation) | Other | In the control group, infant diaper care will be carried out without parental participation. Receives: Other: No parental participation |
| Experimental group (mother participation) | Experimental | In the experimental group, infant diaper care will be provided with the mothers. Receives: Other: Mother participation |
| Experimental group (father participation) | Experimental | In the experimental group, infant diaper care will be provided with the fathers. Receives: Other: Father participation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: immediately before the procedure, during the procedure, immediately after the procedure. The change in these time intervals will be assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start19 Dec 2023
- Primary completion18 Oct 2024
- Study completion18 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PretermStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Kan Onturk, Acibadem University
- Investigators
- Tuğba Turker, Nurse, Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345742
- Sponsor's protocol ID
- ATADEK-2023-10/396
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33559337Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.
PubMed 8506163Morelius 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.
PubMed 16507341Pichler-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.
PubMed 31709208Prouhet 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.
PubMed 29595549
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Parental Participation on Newborn Comfort During Diaper Care Practice in Preterm Infants
- ClinicalTrials.gov ID
- NCT06345742
- Acronym / sponsor ID
- ATADEK-2023-10/396
- Conditions
- Preterm
- Keywords
- diaper care, newborn comfort, parental participation, preterm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 18 Oct 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group (no parental participation) | Other | Other: No parental participationIn the control group, infant diaper care will be carried out without parental participation. |
| Experimental group (mother participation) | Experimental | Other: Mother participationIn the experimental group, infant diaper care will be provided with the mothers. |
| Experimental group (father participation) | Experimental | Other: Father participationIn the experimental group, infant diaper care will be provided with the fathers. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants whose gestational age is between ≥34 weeks and ≤36+6 weeks at the time of application
- Infants with stable health conditions
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No parental participation1. 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. | Other | Control group (no parental participation) |
| Mother participation1. 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. | Other | Experimental group (mother participation) |
| Father participation1. 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. | Other | Experimental group (father participation) |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Results publication: PubMed 33559337Girabent-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.
- Results publication: PubMed 8506163Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.
- Results publication: PubMed 16507341Morelius 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.
- Results publication: PubMed 31709208Pichler-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.
- Results publication: PubMed 29595549Prouhet 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuğba Turker, Nurse principal investigator
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No parental participation, Mother participation and Father participation in people with Preterm, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of Parental Stress (time frame: It will be measured once just before the diaper care). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06345742, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.