Preterm BirthNCT05431452
Reducing Pain During Heel Blood Collection in Preterm Newborns
A study testing Pain management in people with Preterm Birth and Pain, Acute, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
Pharmacological and non-pharmacological methods are used to control interventional pain in preterm newborns. Non-pharmacological methods should be preferred in the management of pain, especially during painful minor invasive procedures (blood collection, orogastric tube insertion, aspiration, etc.) applied during the… Read more about this study
- Who is it for?
- Ages 3 to 5 daysHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Pain, Acute
- What is being tested?
- Pain management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2022to 1 Jun 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 3 to 5 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestation week between 34(0)/7 - 36(6)/7 weeks
- Stable physiological condition
- Able to maintain spontaneous breathing
- Able to take breast milk
- Not exposed to a painful procedure at least half an hour before the intervention.
- Late preterm newborns not taking opioid or non-opioid analgesics will be included in the -study.
Who cannot join
- Receiving mechanical ventilator support
- Congenital anomaly
- Using analgesic/narcotic analgesic drugs
- Babies who receive treatment with continuous sedation will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Suleyman Demirel University
Isparta, 32000
Şerife Tutar, +0905053126429, serifeguven@sdu.edu.tr
Nazmiye Yirik, +905536628910, nbasturk92@gmail.com
About this study
Official title: Evaluation of the Effect of Fetal Position, Kangaroo Care, Breast Milk and Combined Fetal Position and Kangaroo Care in Reducing Pain During Heel Blood Collection in Preterm Newborns.
Pharmacological and non-pharmacological methods are used to control interventional pain in preterm newborns. Non-pharmacological methods should be preferred in the management of pain, especially during painful minor invasive procedures (blood collection, orogastric tube insertion, aspiration, etc.) applied during the day. Some of these methods are; kangaroo care, breast milk, fetal positioning, breastfeeding, listening to music and massage.
Taking heel blood from babies who are being treated in the neonatal intensive care unit is among the duties, authorities and responsibilities of neonatal intensive care nurses. In addition, the effective management of pain by using non-pharmacological methods is among the professional ethical responsibilities of nurses working in neonatal intensive care units. While fulfilling these responsibilities, nurses should conduct researches with high levels of evidence and benefit from the researches effectively. In this context, determining the most effective non-pharmacological method and activating it in a clinical setting form the basis of nursing practices. In this context, the aim of our research is; The aim of this study is to evaluate the effects of fetal position, kangaroo care, combined fetal position with breast milk and breast milk, and kangaroo care in reducing pain during heel blood collection in preterm newborns.
Read the detailed description
The aim of this study is to evaluate the effects of fetal position, kangaroo care, combined fetal position with breast milk and breast milk, and kangaroo care in reducing pain during heel blood collection in preterm newborns. The sample of the study will consist of late preterm newborns who meet the inclusion criteria of the study. It is envisaged that 40 babies will be included in the sample for each group. Randomization will be done in order to provide an equal number of samples for the intervention and control groups in the study. In the randomization to be made, the "simple randomization method" will be used in order to provide equal samples for all three groups. The data of the study will be collected by the clinical nurse working as a nurse in the clinic where the research is conducted, in accordance with the randomization scheme. Physiological parameters of all babies will be monitored on the monitor during the interventions. During the research, all groups will be video-recorded for 10 minutes before the procedure, during the procedure and for 5 minutes after the procedure. After the data of the study are collected, all video recordings will be examined by two researchers (a neonatal intensive care nurse and a neonatal intensive care specialist) and PIPP-R The scale will be filled in by these two independent observers. Descriptive statistics (mean, standard deviation) will be used for the quantitative variables of the research determined by measurement, and descriptive statistics (number, percentage) will be used for the qualitative variables determined by counting. The conformity of the data to be used with the normal distribution will be determined by the Shapiro-Wilk test. In paired comparisons between variables with two categories such as gender, t-test, Analysis of Variance will be applied to find the differences between variables with three or more categories such as group. Paired-sample t-test will be applied between dependent groups for the features that are significant as a result of the analysis of variance. Mann Whitney U test, Wilcoxon test and correlation analyzes will be used to evaluate the relationships between dependent and independent variables. Results will be evaluated at 95% confidence interval and p<0.05 significance level.
- Conditions
- Preterm Birth, Pain, Acute
- Being tested
- Pain management
- Keywords
- preterm birth, pain, nursing care
- Medical subject headings
- Premature Birth, Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain managementOther
Nonpharmacological pain management during blood collection in preterm infants
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Control Group) | No intervention | There is no non-pharmacological method applied during routine heel blood collection in the clinic where the research will be conducted. No intervention will be applied to this group within the scope of the research. In order to minimize the risk of aspiration during the procedure, the head of the bed in the incubator will be elevated at a 45-degree angle. The 1st minute before the procedure, the 1st minute and the 2nd minute during and after the procedure will be recorded with a video camera and the data on the monitor will be recorded in the "Physiological Parameters Measurement Form". |
| Group 2 (Breast milk) | Experimental | 2 minutes before the procedure, the bedside of the baby will be raised at an angle of 45 degrees and 2 ml of breast milk will be given by the research clinic nurse with the help of a sterile injector, provided that each baby will be their own breast milk. Heel blood collection will be performed 2 minutes after breast milk is given. The 1st minute before the procedure, the 1st and 2nd minutes during and after the procedure will be recorded with a video camera and the data on the monitor will be recorded in the "Physiological Parameters Measurement Form". Receives: Other: Pain management |
| Group 3 (Supine Fetal Position) | Experimental | This method is a lower form of the method of taking the baby into the nest and is defined as the process of keeping the baby's upper and lower extremities flexed by hand, and taking the body into a closed position close to the midline. While applying this method, the baby can be placed in a lateral, supine or prone position (Neto et al., 2020).
In our research, according to the literature, the baby will be placed in the fetal position 3 minutes before the procedure, and the baby will be kept in the fetal position for 3 minutes after the procedure. The 1st minute before the procedure, the 1st and 2nd minutes during and after the procedure will be recorded with a video camera and the data on the monitor will be recorded in the "Physiological Parameters Measurement Form". Receives: Other: Pain management |
| Group 4 (Kangaroo maternal care) | Experimental | 10 minutes before the procedure, the mother will be placed on the mother's chest at an angle of 60 degrees, with only the diaper left under the baby in the baby adjustment room, in a way that it will contact the mother's chest directly from skin to skin. In order not to lower the newborn's body temperature, a thin blanket will be covered on his back and the mother will be asked to gently soothe the baby's movements by wrapping her hands around the newborn's back. The mother will be instructed not to make additional movements such as stroking, talking, feeding and shaking her baby. After 10 minutes of kangaroo mother care, heel blood collection will be performed and after the procedure, kangaroo mother care will continue for 2 more minutes. The 1st minute before the procedure, the 1st and 2nd minutes during and after the procedure will be recorded with a video camera and the data on the monitor will be recorded in the "Physiological Parameters Measurement Form". Receives: Other: Pain management |
| Group 5 (Supine Fetal position + Breast milk) | Experimental | The head of the baby's bed is elevated to a 45-degree angle and before the procedure, 2 ml of breast milk will be given with the help of a sterile injector by the research clinical nurse, on the condition that each baby has its own breast milk, and then the baby will be placed in the fetal position (Shah et al., 2012; Shukla et al. , 2018). After the baby is held in the fetal position for 3 minutes, heel blood sampling will be performed. The 1st minute before the procedure, the 1st and 2nd minutes during and after the procedure will be recorded with a video camera and the data on the monitor will be recorded in the "Physiological Parameters Measurement Form". In line with the literature recommendations, the baby will be supported in the fetal position for 3 minutes after the procedure (Axelin et al. 2006; Cignacco et al. 2010; Obeidat et al. 2009; Çağlayan and Balci, 2014). Receives: Other: Pain management |
| Group 6 (Kangaroo care + Breast milk) | Experimental | The head of the baby's bed will be raised at an angle of 45 degrees and before the procedure, 2 ml of breast milk will be given by the research clinical nurse with the help of a sterile injector, provided that each baby is breast milk, and then the mother will be in direct skin-to-skin contact with the mother's breast, with only the diaper under the baby in the baby adaptation room. It will be placed on the mother's chest at an angle of 60 degrees. The mother will be instructed not to make additional movements such as stroking, talking, feeding and shaking her baby. After 10 minutes of kangaroo mother care, heel blood collection will be performed and after the procedure, kangaroo mother care will continue for 2 more minutes. The 1st minute before the procedure, the 1st and 2nd minutes during and after the procedure will be recorded with a video camera and the data on the monitor will be recorded in the "Physiological Parameters Measurement Form". Receives: Other: Pain management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain management
Management of pain heel puncture in premature newborn. The parameter for pain management will be determined by the Premature Infant Pain Profile (PIPP)
Measured: 10 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start1 Mar 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- 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
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serife Tutar, Suleyman Demirel University
- Investigators
- Şerife Tutar, Principal investigator, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431452
- Sponsor's protocol ID
- 206337
- Status last verified
- Jan 2024
- First submitted
- 21 Apr 2022
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is planned to publish the research data in the form of an article.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Fetal Position, Kangaroo Care, Breast Milk and Combined Fetal Position and Kangaroo Care in Reducing Pain During Heel Blood Collection in Preterm Newborns.
- ClinicalTrials.gov ID
- NCT05431452
- Acronym / sponsor ID
- 206337
- Conditions
- Preterm Birth, Pain, Acute
- Keywords
- preterm birth, pain, nursing care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 24 Jun 2022 (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.
Pharmacological and non-pharmacological methods are used to control interventional pain in preterm newborns. Non-pharmacological methods should be preferred in the management of pain, especially during painful minor invasive procedures (blood collection, orogastric tube insertion, aspiration, etc.) applied during the day. Some of these methods are; kangaroo care, breast milk, fetal positioning, breastfeeding, listening to music and massage.
Taking heel blood from babies who are being treated in the neonatal intensive care unit is among the duties, authorities and responsibilities of neonatal intensive care nurses. In addition, the effective management of pain by using non-pharmacological methods is among the professional ethical responsibilities of nurses working in neonatal intensive care units. While fulfilling these responsibilities, nurses should conduct researches with high levels of evidence and benefit from the researches effectively. In this context, determining the most effective non-pharmacological method and activating it in a clinical setting form the basis of nursing practices. In this context, the aim of our research is; The aim of this study is to evaluate the effects of fetal position, kangaroo care, combined fetal position with breast milk and breast milk, and kangaroo care in reducing pain during heel blood collection in preterm newborns.
Detailed description
The aim of this study is to evaluate the effects of fetal position, kangaroo care, combined fetal position with breast milk and breast milk, and kangaroo care in reducing pain during heel blood collection in preterm newborns. The sample of the study will consist of late preterm newborns who meet the inclusion criteria of the study. It is envisaged that 40 babies will be included in the sample for each group. Randomization will be done in order to provide an equal number of samples for the intervention and control groups in the study. In the randomization to be made, the "simple randomization method" will be used in order to provide equal samples for all three groups. The data of the study will be collected by the clinical nurse working as a nurse in the clinic where the research is conducted, in accordance with the randomization scheme. Physiological parameters of all babies will be monitored on the monitor during the interventions. During the research, all groups will be video-recorded for 10 minutes before the procedure, during the procedure and for 5 minutes after the procedure. After the data of the study are collected, all video recordings will be examined by two researchers (a neonatal intensive care nurse and a neonatal intensive care specialist) and PIPP-R The scale will be filled in by these two independent observers. Descriptive statistics (mean, standard deviation) will be used for the quantitative variables of the research determined by measurement, and descriptive statistics (number, percentage) will be used for the qualitative variables determined by counting. The conformity of the data to be used with the normal distribution will be determined by the Shapiro-Wilk test. In paired comparisons between variables with two categories such as gender, t-test, Analysis of Variance will be applied to find the differences between variables with three or more categories such as group. Paired-sample t-test will be applied between dependent groups for the features that are significant as a result of the analysis of variance. Mann Whitney U test, Wilcoxon test and correlation analyzes will be used to evaluate the relationships between dependent and independent variables. Results will be evaluated at 95% confidence interval and p<0.05 significance level.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Control Group) | No intervention | –There is no non-pharmacological method applied during routine heel blood collection in the clinic where the research will be conducted. No intervention will be applied to this group within the scope of the research. In order to minimize the risk of aspiration during the procedure, the head of the bed in the incubator will be elevated at a 45-degree angle. The 1st minute before the procedure, the 1st minute and the 2nd minute during and after the procedure will be recorded with a video camera and the data on the monitor will be recorded in the "Physiological Parameters Measurement Form". |
| Group 2 (Breast milk) | Experimental | Other: Pain management2 minutes before the procedure, the bedside of the baby will be raised at an angle of 45 degrees and 2 ml of breast milk will be given by the research clinic nurse with the help of a sterile injector, provided that each baby will be their own breast milk. Heel blood collection will be performed 2 minutes after breast milk is given. The 1st minute before the procedure, the 1st and 2nd minutes during and after the procedure will be recorded with a video camera and the data on the monitor will be recorded in the "Physiological Parameters Measurement Form". |
| Group 3 (Supine Fetal Position) | Experimental | Other: Pain managementThis method is a lower form of the method of taking the baby into the nest and is defined as the process of keeping the baby's upper and lower extremities flexed by hand, and taking the body into a closed position close to the midline. While applying this method, the baby can be placed in a lateral, supine or prone position (Neto et al., 2020). In our research, according to the literature, the baby will be placed in the fetal position 3 minutes before the procedure, and the baby will be kept in the fetal position for 3 minutes after the procedure. The 1st minute before the procedure, the 1st and 2nd minutes during and after the procedure will be recorded with a video camera and the data on the monitor will be recorded in the "Physiological Parameters Measurement Form". |
| Group 4 (Kangaroo maternal care) | Experimental | Other: Pain management10 minutes before the procedure, the mother will be placed on the mother's chest at an angle of 60 degrees, with only the diaper left under the baby in the baby adjustment room, in a way that it will contact the mother's chest directly from skin to skin. In order not to lower the newborn's body temperature, a thin blanket will be covered on his back and the mother will be asked to gently soothe the baby's movements by wrapping her hands around the newborn's back. The mother will be instructed not to make additional movements such as stroking, talking, feeding and shaking her baby. After 10 minutes of kangaroo mother care, heel blood collection will be performed and after the procedure, kangaroo mother care will continue for 2 more minutes. The 1st minute before the procedure, the 1st and 2nd minutes during and after the procedure will be recorded with a video camera and the data on the monitor will be recorded in the "Physiological Parameters Measurement Form". |
| Group 5 (Supine Fetal position + Breast milk) | Experimental | Other: Pain managementThe head of the baby's bed is elevated to a 45-degree angle and before the procedure, 2 ml of breast milk will be given with the help of a sterile injector by the research clinical nurse, on the condition that each baby has its own breast milk, and then the baby will be placed in the fetal position (Shah et al., 2012; Shukla et al. , 2018). After the baby is held in the fetal position for 3 minutes, heel blood sampling will be performed. The 1st minute before the procedure, the 1st and 2nd minutes during and after the procedure will be recorded with a video camera and the data on the monitor will be recorded in the "Physiological Parameters Measurement Form". In line with the literature recommendations, the baby will be supported in the fetal position for 3 minutes after the procedure (Axelin et al. 2006; Cignacco et al. 2010; Obeidat et al. 2009; Çağlayan and Balci, 2014). |
| Group 6 (Kangaroo care + Breast milk) | Experimental | Other: Pain managementThe head of the baby's bed will be raised at an angle of 45 degrees and before the procedure, 2 ml of breast milk will be given by the research clinical nurse with the help of a sterile injector, provided that each baby is breast milk, and then the mother will be in direct skin-to-skin contact with the mother's breast, with only the diaper under the baby in the baby adaptation room. It will be placed on the mother's chest at an angle of 60 degrees. The mother will be instructed not to make additional movements such as stroking, talking, feeding and shaking her baby. After 10 minutes of kangaroo mother care, heel blood collection will be performed and after the procedure, kangaroo mother care will continue for 2 more minutes. The 1st minute before the procedure, the 1st and 2nd minutes during and after the procedure will be recorded with a video camera and the data on the monitor will be recorded in the "Physiological Parameters Measurement Form". |
Who may qualify
- Ages
- 3 to 5 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Gestation week between 34(0)/7 - 36(6)/7 weeks
- Stable physiological condition
- Able to maintain spontaneous breathing
- Able to take breast milk
- Not exposed to a painful procedure at least half an hour before the intervention.
Key exclusion criteria (4 listed)
- Receiving mechanical ventilator support
- Congenital anomaly
- Using analgesic/narcotic analgesic drugs
- Babies who receive treatment with continuous sedation will not be included in the study.
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 |
|---|---|---|
| Pain managementNonpharmacological pain management during blood collection in preterm infants | Other | Group 2 (Breast milk), Group 3 (Supine Fetal Position), Group 4 (Kangaroo maternal care), Group 5 (Supine Fetal position + Breast milk), Group 6 (Kangaroo care + Breast milk) |
Primary outcome
Pain management
Time frame: 10 month
Management of pain heel puncture in premature newborn. The parameter for pain management will be determined by the Premature Infant Pain Profile (PIPP)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: No. It is planned to publish the research data in the form of an article.
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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.
Şerife Tutar principal investigator
Suleyman Demirel 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 Pain management in people with Preterm Birth and Pain, Acute, run by Suleyman Demirel 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 6 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Şerife Tutar (+905053126429, serifeguven@sdu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain management (time frame: 10 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jan 2024.