Infant, Premature, DiseasesNCT04528602
The Effect of Diaper Change Position on Preterm Infants
A study testing Experimental (Legs are flexed toward abdomen) Group in people with Infant, Premature, Diseases, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine the effect of diaper change position on neonatal comfort and heart rate, respiratory rate and oxygen saturation in preterm infants. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Infant, Premature, Diseases
- What is being tested?
- Experimental (Legs are flexed toward abdomen) Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 May 2019to 1 May 2020
- 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
- No healthy volunteers
- Child
Who may be able to join
- The preterm infants whose
- Parents have agreed to participate in the study and have signed the informed consent form,
- Who have no congenital anomalies,
- Have no chronic illnesses,
- Have undergone Underwent no surgical procedures,
- Have no neurological symptoms,
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- Have not been diagnosed with sepsis,
- Have not been sedated,
- Have not received any pharmacological analgesic method four hours before,
- Have been born between ≥28 and ≤36+6 gestational weeks or have been born earlier and are between ≥28 and ≤36+6 gestational weeks during the application, will be included.
Who cannot join
- The preterm infants whose
- Parents have not agreed to participate in the study and have not signed the informed consent form,
- Who have congenital anomalies,
- Have chronic illnesses,
- Have undergone surgical procedures,
- Have neurological symptoms,
Show all 10Show fewer
- Have been diagnosed with sepsis,
- Have been sedated,
- Have received pharmacological analgesic methods four hours before,
- Were between <28 and >36+6 gestational weeks, will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Diaper Change Position on Neonatal Comfort and Heart Rate, Respiratory Rate and Oxygen Saturation in Preterm Infants
The purpose of this study is to determine the effect of diaper change position on neonatal comfort and heart rate, respiratory rate and oxygen saturation in preterm infants.
Read the detailed description
This study was planned as a randomized controlled prospective trial until reaching the entire sample group specified in the Neonatal Intensive Care Units (NICU) in a private hospital that has other branches in Istanbul.
During the data collection process, two methods will be applied to preterm infants during diaper change.
In the control group of the study, diaper change will be performed after the legs of the babies are brought to extension, and in the experimental group, the diaper change will be performed after the legs of the babies are brought closer to the abdomen by maintaining their flexion. Data on the babies' heart rate, respiratory rate, oxygen saturation and comfort level will be collected using the Premature Infant Comfort Scale before, during, immediately after and 3 minutes after the procedure.
The researchers will collect the data by using a form that questions individual characteristics and includes records of heart rate, respiratory rate and oxygen saturation and Premature Infant Comfort.
- Conditions
- Infant, Premature, Diseases
- Being tested
- Control (Extended leg position) Group, Experimental (Legs are flexed toward abdomen) Group
- Keywords
- preterm, diaper change, comfort, position
- Medical subject headings
- Infant, Premature, Diseases, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control (Extended leg position) GroupProcedure or surgery
Common procedure steps -Legal representatives of the infants will sign an informed consent form. Materials (soap, napkin, non-sterile gloves, diaper, wet cotton towels for newborns, waste container, diaper change mat) will be prepared.
Hands will be washed and gloves will be worn. Tapes of the infant's dirty diaper will be opened.
For the Control Group
-The infant will be grasped on the legs, the legs will be given extension position and lifted up.
The dirty diaper will be folded in two and the perineum area will be wiped with a wet cotton towel from the front to the back.
The infant's feet will be freed. The dirty diaper will be removed and thrown into the general waste bin. The used gloves will be removed.
The infant's legs will be given in extension position and a clean diaper will be placed under them.
Tapes of the clean diaper will be fastened. Hands will be washed after the procedure Data will be collected before, during, after and 3 minutes after application.
Experimental (Legs are flexed toward abdomen) GroupProcedure or surgery
Procedure steps for the Experimental Group
- Common procedure steps
- The infant will be grasped on the legs; the legs will be kept in the flexion position and approached toward the abdomen.
- The dirty diaper will be folded in two and the perineum area will be wiped with a wet cotton towel from the front to the back.
- The infant's feet will be freed.
- The dirty diaper will be removed and thrown into the general waste bin. The used gloves will be removed and thrown into the medical waste bin.
- The infant's legs will be kept in the flexion position and a clean diaper will be placed under them. A bottom care plan will be applied in line with the treatment plan, if necessary.
- Tapes of the clean diaper will be fastened.
- Hands will be washed after the procedure.
- Data will be collected immediately before, during, immediately after and 3 minutes after the end of application.
| Study group | Role | What they receive |
|---|---|---|
| Control (Extended leg position) Group | Experimental | In the control (Extended leg position) group of the study, diaper change will be performed after the legs of the babies are brought to extension. Receives: Procedure: Control (Extended leg position) Group |
| Experimental (Legs are flexed toward abdomen) Group | Experimental | In the experimental (Legs are flexed toward abdomen) group, the diaper change will be performed after the legs of the babies are brought closer to the abdomen while maintaining their flexion leg position. Receives: Procedure: Experimental (Legs are flexed toward abdomen) Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart rate
Preterm infant will be monitored and heart rate will be monitored.
Measured: Data will be collected immediately before, during, immediately after and 3 minutes after the end of application. The change in these time intervals will be assessed.
Change in Respiratory Rate
Preterm infant will be monitored and respiratory rate will be monitored.
Measured: Data will be collected immediately before, during, immediately after and 3 minutes after the end of application. The change in these time intervals will be assessed.
Change in Oxygen Saturation
Preterm infant will be monitored and respiratory rate will be monitored.
Measured: Data will be collected immediately before, during, immediately after and 3 minutes after the end of application. The change in these time intervals will be assessed.
Change in Comfort
Premature Infant Comfort Scale (PICS), which is a multidimensional scale used in evaluating comfort and pain behaviorally and psychologically. The PICS evaluates seven parameters as Alertness, Calmness/Agitation, Respiratory Status (only on mechanic ventilation support) or Crying (not evaluated because it is scored in children with spontaneous breathing), Physical Movements, Muscle Tone, Facial Gestures and Mean Heart Rate. It is a five-point likert scale in which each element is scored from one to five (from bad to good). According to the PICS, the infant's comfort is evaluated over the total score. Accordingly, 35 points signify the lowest comfort score, while seven points signify the highest comfort score. High score obtained from the scale signifies that the comfort level is low. If the total score is ≥17, this is the cut-off value of the scale. It was found that the Turkish version was a valid and reliable.
Measured: Data will be collected immediately before, during, immediately after and 3 minutes after the end of application. 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 posted27 Aug 2020
- Study start17 May 2019
- Primary completion1 May 2020
- Study completion1 May 2020
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 Infant, Premature, DiseasesStudies 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
- 60 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
- Zehra Kan Öntürk, Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04528602
- Sponsor's protocol ID
- 2019-5/12
- Status last verified
- Aug 2021
- First submitted
- 20 Aug 2020
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lyngstad LT, Tandberg BS, Storm H, Ekeberg BL, Moen A. Does skin-to-skin contact reduce stress during diaper change in preterm infants? Early Hum Dev. 2014 Apr;90(4):169-72. doi: 10.1016/j.earlhumdev.2014.01.011. Epub 2014 Feb 16.
PubMed 24548816Morelius 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 16507341Kolcaba KY. Holistic comfort: operationalizing the construct as a nurse-sensitive outcome. ANS Adv Nurs Sci. 1992 Sep;15(1):1-10. doi: 10.1097/00012272-199209000-00003.
PubMed 1519906Grunau RE, Weinberg J, Whitfield MF. Neonatal procedural pain and preterm infant cortisol response to novelty at 8 months. Pediatrics. 2004 Jul;114(1):e77-84. doi: 10.1542/peds.114.1.e77.
PubMed 15231977Picheansathian W, Woragidpoonpol P, Baosoung C. Positioning of Preterm Infants for Optimal Physiological Development: a systematic review. JBI Libr Syst Rev. 2009;7(7):224-259. doi: 10.11124/01938924-200907070-00001.
PubMed 27820087
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diaper Change Position on Neonatal Comfort and Heart Rate, Respiratory Rate and Oxygen Saturation in Preterm Infants
- ClinicalTrials.gov ID
- NCT04528602
- Acronym / sponsor ID
- 2019-5/12
- Conditions
- Infant, Premature, Diseases
- Keywords
- preterm, diaper change, comfort, position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 17 May 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 27 Aug 2020 (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.
The purpose of this study is to determine the effect of diaper change position on neonatal comfort and heart rate, respiratory rate and oxygen saturation in preterm infants.
Detailed description
This study was planned as a randomized controlled prospective trial until reaching the entire sample group specified in the Neonatal Intensive Care Units (NICU) in a private hospital that has other branches in Istanbul.
During the data collection process, two methods will be applied to preterm infants during diaper change.
In the control group of the study, diaper change will be performed after the legs of the babies are brought to extension, and in the experimental group, the diaper change will be performed after the legs of the babies are brought closer to the abdomen by maintaining their flexion. Data on the babies' heart rate, respiratory rate, oxygen saturation and comfort level will be collected using the Premature Infant Comfort Scale before, during, immediately after and 3 minutes after the procedure.
The researchers will collect the data by using a form that questions individual characteristics and includes records of heart rate, respiratory rate and oxygen saturation and Premature Infant Comfort.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (Extended leg position) Group | Experimental | Procedure: Control (Extended leg position) GroupIn the control (Extended leg position) group of the study, diaper change will be performed after the legs of the babies are brought to extension. |
| Experimental (Legs are flexed toward abdomen) Group | Experimental | Procedure: Experimental (Legs are flexed toward abdomen) GroupIn the experimental (Legs are flexed toward abdomen) group, the diaper change will be performed after the legs of the babies are brought closer to the abdomen while maintaining their flexion leg position. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- The preterm infants whose
- Parents have agreed to participate in the study and have signed the informed consent form,
- Who have no congenital anomalies,
- Have no chronic illnesses,
- Have undergone Underwent no surgical procedures,
Key exclusion criteria (10 listed)
- The preterm infants whose
- Parents have not agreed to participate in the study and have not signed the informed consent form,
- Who have congenital anomalies,
- Have chronic illnesses,
- Have undergone surgical procedures,
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 |
|---|---|---|
| Control (Extended leg position) GroupCommon procedure steps -Legal representatives of the infants will sign an informed consent form. Materials (soap, napkin, non-sterile gloves, diaper, wet cotton towels for newborns, waste container, diaper change mat) will be prepared. Hands will be washed and gloves will be worn. Tapes of the infant's dirty diaper will be opened. For the Control Group -The infant will be grasped on the legs, the legs will be given extension position and lifted up. The dirty diaper will be folded in two and the perineum area will be wiped with a wet cotton towel from the front to the back. The infant's feet will be freed. The dirty diaper will be removed and thrown into the general waste bin. The used gloves will be removed. The infant's legs will be given in extension position and a clean diaper will be placed under them. Tapes of the clean diaper will be fastened. Hands will be washed after the procedure Data will be collected before, during, after and 3 minutes after application. | Procedure or surgery | Control (Extended leg position) Group |
| Experimental (Legs are flexed toward abdomen) GroupProcedure steps for the Experimental Group * Common procedure steps * The infant will be grasped on the legs; the legs will be kept in the flexion position and approached toward the abdomen. * The dirty diaper will be folded in two and the perineum area will be wiped with a wet cotton towel from the front to the back. * The infant's feet will be freed. * The dirty diaper will be removed and thrown into the general waste bin. The used gloves will be removed and thrown into the medical waste bin. * The infant's legs will be kept in the flexion position and a clean diaper will be placed under them. A bottom care plan will be applied in line with the treatment plan, if necessary. * Tapes of the clean diaper will be fastened. * Hands will be washed after the procedure. * Data will be collected immediately before, during, immediately after and 3 minutes after the end of application. | Procedure or surgery | Experimental (Legs are flexed toward abdomen) Group |
Primary outcome
Change in Heart rate
Time frame: Data will be collected immediately before, during, immediately after and 3 minutes after the end of application. The change in these time intervals will be assessed.
Preterm infant will be monitored and heart rate will be monitored.
Change in Respiratory Rate
Time frame: Data will be collected immediately before, during, immediately after and 3 minutes after the end of application. The change in these time intervals will be assessed.
Preterm infant will be monitored and respiratory rate will be monitored.
Change in Oxygen Saturation
Time frame: Data will be collected immediately before, during, immediately after and 3 minutes after the end of application. The change in these time intervals will be assessed.
Preterm infant will be monitored and respiratory rate will be monitored.
Change in Comfort
Time frame: Data will be collected immediately before, during, immediately after and 3 minutes after the end of application. The change in these time intervals will be assessed.
Premature Infant Comfort Scale (PICS), which is a multidimensional scale used in evaluating comfort and pain behaviorally and psychologically. The PICS evaluates seven parameters as Alertness, Calmness/Agitation, Respiratory Status (only on mechanic ventilation support) or Crying (not evaluated because it is scored in children with spontaneous breathing), Physical Movements, Muscle Tone, Facial Gestures and Mean Heart Rate. It is a five-point likert scale in which each element is scored from one to five (from bad to good). According to the PICS, the infant's comfort is evaluated over the total score. Accordingly, 35 points signify the lowest comfort score, while seven points signify the highest comfort score. High score obtained from the scale signifies that the comfort level is low. If the total score is ≥17, this is the cut-off value of the scale. It was found that the Turkish version was a valid and reliable.
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 25 Aug 2021.
- Background: PubMed 24548816Lyngstad LT, Tandberg BS, Storm H, Ekeberg BL, Moen A. Does skin-to-skin contact reduce stress during diaper change in preterm infants? Early Hum Dev. 2014 Apr;90(4):169-72. doi: 10.1016/j.earlhumdev.2014.01.011. Epub 2014 Feb 16.
- Background: 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.
- Background: PubMed 1519906Kolcaba KY. Holistic comfort: operationalizing the construct as a nurse-sensitive outcome. ANS Adv Nurs Sci. 1992 Sep;15(1):1-10. doi: 10.1097/00012272-199209000-00003.
- Background: PubMed 15231977Grunau RE, Weinberg J, Whitfield MF. Neonatal procedural pain and preterm infant cortisol response to novelty at 8 months. Pediatrics. 2004 Jul;114(1):e77-84. doi: 10.1542/peds.114.1.e77.
- Background: PubMed 27820087Picheansathian W, Woragidpoonpol P, Baosoung C. Positioning of Preterm Infants for Optimal Physiological Development: a systematic review. JBI Libr Syst Rev. 2009;7(7):224-259. doi: 10.11124/01938924-200907070-00001.
- 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.
Zehra Kan Öntürk 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 Experimental (Legs are flexed toward abdomen) Group in people with Infant, Premature, Diseases, 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 10 inclusion and 10 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 25 Aug 2021. 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?
Change in Heart rate (time frame: Data will be collected immediately before, during, immediately after and 3 minutes after the end of application. The change in these time intervals will be assessed.). The study lists 4 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 NCT04528602, 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 25 Aug 2021.