PainNCT05797532
Comparison of Different Methods for Reducing Pain in Heel Blood in Newborns
A study testing breastfeeding, skin to skin contact and swaddling and holding in people with Pain, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Newborns are exposed to painful invasive procedures from the first hours of their lives. It is stated that the functional and anatomical structure of the neural pathways of newborns with many systems immature develops well enough to feel pain and they have the ability to remember after experiencing pain. Read more about this study
- Who is it for?
- Ages 24 to 36 hoursHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- breastfeeding, skin to skin contact and swaddling and holding
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Nov 2019to 31 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 24 to 36 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Newborns (0-28days);
- Being born at term (38 - 42 weeks)
- Stable vital signs
- Having completed the first 24 hours of life and being fed
- Heel blood procedure will be applied for the Ministry of Health screening.
- Not being breastfed 30 minutes before the procedure
Show all 9Show fewer
- No previous invasive intervention other than vitamin K and hepatitis B vaccine.
- 1st and 5th minute Apgar score ≥7
- Parents have given written consent.
Who cannot join
- Newborns (0-28days);
- Unstable vital signs
- Being bottle-fed or formula-fed
- Having a neurological diagnosis
- Prior exposure to another invasive procedure other than vitamin K and hepatitis B vaccine.
- Maternal use of opioids,
- Not being born at term.
Trial locations and contacts
1 site in 1 country.
About this study
Newborns are exposed to painful invasive procedures from the first hours of their lives. It is stated that the functional and anatomical structure of the neural pathways of newborns with many systems immature develops well enough to feel pain and they have the ability to remember after experiencing pain. Physiological symptoms (increase in heart rate and blood pressure, increase in oxygen saturation, etc.) as a result of painful procedures (vascular or heel lance collection, venous or arterial catheterization, subcutaneous and intramuscular injection, chest tube insertion, intubation, aspiration, etc.) applied for diagnosis and treatment in newborns. falling), crying behavior and metabolic problems. In conclusion, the energy resources required for the growth and development of newborns are used to cope with pain, and it is reported that repetitive painful procedures increase mortality and morbidity in newborns.
Heel lance, which is applied to all newborns within the scope of the newborn screening program, is one of the painful invasive procedures for newborns. Heel lance should be taken as capillaries in the first 48 hours after feeding or until the first week of life of newborns. In the literature, non-pharmacological methods applied to reduce the severity of pain felt by newborns during heel lance, which also causes tissue integrity deterioration; It has been observed that studies examining the effects of breast milk, swaddling, holding, breastfeeding, music, oral sucrose, non-nutritive sucking, skin-to-skin contact (SSC) and positioning. SSC, breastfeeding and swaddling + holding methods are among the methods that can be easily used by mothers and nurses. Nurses working in the maternity ward where heel lance sampling is performed in the hospital have a key role in reducing the pain level of newborns by collaborating with the families of the babies.
Read the detailed description
This study was conducted to compare three different methods (breastfeeding, skin-to-skin contact, swaddling + holding) in reducing the pain felt during routine heel lance from term newborns within the scope of the National "Newborn Screening Program" of the Ministry of Health.
Hypotheses; H1: Breastfeeding method is more effective than skin-to-skin contact and swaddling + holding methods in reducing pain due to heel lance in newborns.
H2: Skin-to-skin contact method is more effective than breastfeeding and swaddling + holding methods in reducing pain due to heel lance collection in newborns.
H3: Swaddling + holding method is more effective than breastfeeding and skin-to-skin contact methods in reducing the pain associated with heel lance collection in newborns.
Statistical power analysis was performed at the end of the study in line with the data collected from a total of 90 newborns, 30 of whom were in each study group. The power of the study was found to be 0.81 - 0.99 at the alpha = 0.05 significance level, and the effect size was between 0.02 and 0.68.
- Conditions
- Pain
- Being tested
- breastfeeding, skin to skin contact, swaddling and holding
- Keywords
- heel lance, breastfeeding, swaddling and holding, skin to skin contact
- Medical subject headings
- Pain, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breastfeedingOther
The NIPS (Neonatal Infant Pain Scale) pain score, heart rate and oxygen saturation of the newborn were recorded by the researcher in the study group, 2 minutes before the heel lance, 10 seconds during the heel lance, and 2 minutes after the heel lance was completed.
In order to determine the crying time of newborns in all three study groups, the voice recorder and stopwatch were turned on two minutes before and 2 minutes after the heel lance.
skin to skin contactOther
The NIPS (Neonatal Infant Pain Scale) pain score, heart rate and oxygen saturation of the newborn were recorded by the researcher in the study group, 2 minutes before the heel lance, 10 seconds during the heel lance, and 2 minutes after the heel lance was completed.
In order to determine the crying time of newborns in all three study groups, the voice recorder and stopwatch were turned on two minutes before and 2 minutes after the heel lance.
swaddling and holdingOther
The NIPS (Neonatal Infant Pain Scale) pain score, heart rate and oxygen saturation of the newborn were recorded by the researcher in the study group, 2 minutes before the heel lance, 10 seconds during the heel lance, and 2 minutes after the heel lance was completed.
In order to determine the crying time of newborns in all three study groups, the voice recorder and stopwatch were turned on two minutes before and 2 minutes after the heel lance.
| Study group | Role | What they receive |
|---|---|---|
| breastfeeding | Active comparator | The mother was allowed to sit comfortably in the patient's room, the pulse oximeter probe was attached to the left foot of the newborn, and the newborn, who was placed on the mother's lap, was breastfeeding for 5 minutes before the heel lance, and breastfeeding was continued during the procedure. Receives: Other: breastfeeding |
| skin to skin contact | Active comparator | The newborn's clothes were removed so that only the diaper and baby hat were left, and a pulse oximeter probe was attached to his left foot. The newborn was placed on the mother's bare chest between her two breasts, facing the mother's face, with her head up, in the prone position, covered with a baby blanket, and skin-to-skin contact was made between the mother and the newborn for at least 5 minutes before starting the heel lance procedure. Receives: Other: skin to skin contact |
| swaddling and holding | Active comparator | A pulse oximeter probe was attached to the newborn's left foot, and the legs were in flexion and abduction position, wrapped with a square cloth blanket and placed on his mother's lap. It was ensured that the newborn was held in the mother's lap with his head up and feet down for 5 minutes before heel lance. Receives: Other: swaddling and holding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of pain scores according to measurement times; before the heel lance procedure, the newborn was 5 minutes after breastfeeding, swaddling and holding, skin-to-skin contact.
Neonatal Infant Pain Scale pain score of the newborn were recorded by the researcher in the breastfeeding, swaddling and holding, skin-to skin-contact groups, 2 minutes before the heel lance, 10 seconds during the heel lance, and 2 minutes after the heel lance was completed.
The lowest score obtained from the scale is 0, and the highest score is 7. A high scale score indicates a high level of pain in the newborn. The scoring of Neonatal Infant Pain Scale ranges from 0-7 points and 0-2 points indicate no pain, 3-4 points indicate moderate pain, >4 points indicate high levels of pain.
Measured: through study completion, an average of 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start18 Nov 2019
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of three different methods
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05797532
- Sponsor's protocol ID
- Nursing12345
- Status last verified
- Dec 2022
- First submitted
- 21 Dec 2022
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Karga Yilmaz T, Yavuz B. Comparison of different methods for reducing pain during a heel lance in newborns: a randomized trial. Ital J Pediatr. 2025 Mar 12;51(1):73. doi: 10.1186/s13052-025-01916-w.
PubMed 40075464
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Methods for Reducing Pain in Heel Blood in Newborns
- ClinicalTrials.gov ID
- NCT05797532
- Acronym / sponsor ID
- Nursing12345
- Conditions
- Pain
- Keywords
- heel lance, breastfeeding, swaddling and holding, skin to skin contact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 4 Apr 2023 (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.
Newborns are exposed to painful invasive procedures from the first hours of their lives. It is stated that the functional and anatomical structure of the neural pathways of newborns with many systems immature develops well enough to feel pain and they have the ability to remember after experiencing pain. Physiological symptoms (increase in heart rate and blood pressure, increase in oxygen saturation, etc.) as a result of painful procedures (vascular or heel lance collection, venous or arterial catheterization, subcutaneous and intramuscular injection, chest tube insertion, intubation, aspiration, etc.) applied for diagnosis and treatment in newborns. falling), crying behavior and metabolic problems. In conclusion, the energy resources required for the growth and development of newborns are used to cope with pain, and it is reported that repetitive painful procedures increase mortality and morbidity in newborns.
Heel lance, which is applied to all newborns within the scope of the newborn screening program, is one of the painful invasive procedures for newborns. Heel lance should be taken as capillaries in the first 48 hours after feeding or until the first week of life of newborns. In the literature, non-pharmacological methods applied to reduce the severity of pain felt by newborns during heel lance, which also causes tissue integrity deterioration; It has been observed that studies examining the effects of breast milk, swaddling, holding, breastfeeding, music, oral sucrose, non-nutritive sucking, skin-to-skin contact (SSC) and positioning. SSC, breastfeeding and swaddling + holding methods are among the methods that can be easily used by mothers and nurses. Nurses working in the maternity ward where heel lance sampling is performed in the hospital have a key role in reducing the pain level of newborns by collaborating with the families of the babies.
Detailed description
This study was conducted to compare three different methods (breastfeeding, skin-to-skin contact, swaddling + holding) in reducing the pain felt during routine heel lance from term newborns within the scope of the National "Newborn Screening Program" of the Ministry of Health.
Hypotheses; H1: Breastfeeding method is more effective than skin-to-skin contact and swaddling + holding methods in reducing pain due to heel lance in newborns.
H2: Skin-to-skin contact method is more effective than breastfeeding and swaddling + holding methods in reducing pain due to heel lance collection in newborns.
H3: Swaddling + holding method is more effective than breastfeeding and skin-to-skin contact methods in reducing the pain associated with heel lance collection in newborns.
Statistical power analysis was performed at the end of the study in line with the data collected from a total of 90 newborns, 30 of whom were in each study group. The power of the study was found to be 0.81 - 0.99 at the alpha = 0.05 significance level, and the effect size was between 0.02 and 0.68.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Comparison of three different methods
| Arm | Type | Receives |
|---|---|---|
| breastfeeding | Active comparator | Other: breastfeedingThe mother was allowed to sit comfortably in the patient's room, the pulse oximeter probe was attached to the left foot of the newborn, and the newborn, who was placed on the mother's lap, was breastfeeding for 5 minutes before the heel lance, and breastfeeding was continued during the procedure. |
| skin to skin contact | Active comparator | Other: skin to skin contactThe newborn's clothes were removed so that only the diaper and baby hat were left, and a pulse oximeter probe was attached to his left foot. The newborn was placed on the mother's bare chest between her two breasts, facing the mother's face, with her head up, in the prone position, covered with a baby blanket, and skin-to-skin contact was made between the mother and the newborn for at least 5 minutes before starting the heel lance procedure. |
| swaddling and holding | Active comparator | Other: swaddling and holdingA pulse oximeter probe was attached to the newborn's left foot, and the legs were in flexion and abduction position, wrapped with a square cloth blanket and placed on his mother's lap. It was ensured that the newborn was held in the mother's lap with his head up and feet down for 5 minutes before heel lance. |
Who may qualify
- Ages
- 24 to 36 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Newborns (0-28days);
- Being born at term (38 - 42 weeks)
- Stable vital signs
- Having completed the first 24 hours of life and being fed
- Heel blood procedure will be applied for the Ministry of Health screening.
Key exclusion criteria (7 listed)
- Newborns (0-28days);
- Unstable vital signs
- Being bottle-fed or formula-fed
- Having a neurological diagnosis
- Prior exposure to another invasive procedure other than vitamin K and hepatitis B vaccine.
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 |
|---|---|---|
| breastfeedingThe NIPS (Neonatal Infant Pain Scale) pain score, heart rate and oxygen saturation of the newborn were recorded by the researcher in the study group, 2 minutes before the heel lance, 10 seconds during the heel lance, and 2 minutes after the heel lance was completed. In order to determine the crying time of newborns in all three study groups, the voice recorder and stopwatch were turned on two minutes before and 2 minutes after the heel lance. | Other | breastfeeding |
| skin to skin contactThe NIPS (Neonatal Infant Pain Scale) pain score, heart rate and oxygen saturation of the newborn were recorded by the researcher in the study group, 2 minutes before the heel lance, 10 seconds during the heel lance, and 2 minutes after the heel lance was completed. In order to determine the crying time of newborns in all three study groups, the voice recorder and stopwatch were turned on two minutes before and 2 minutes after the heel lance. | Other | skin to skin contact |
| swaddling and holdingThe NIPS (Neonatal Infant Pain Scale) pain score, heart rate and oxygen saturation of the newborn were recorded by the researcher in the study group, 2 minutes before the heel lance, 10 seconds during the heel lance, and 2 minutes after the heel lance was completed. In order to determine the crying time of newborns in all three study groups, the voice recorder and stopwatch were turned on two minutes before and 2 minutes after the heel lance. | Other | swaddling and holding |
Primary outcome
Determination of pain scores according to measurement times; before the heel lance procedure, the newborn was 5 minutes after breastfeeding, swaddling and holding, skin-to-skin contact.
Time frame: through study completion, an average of 6 month
Neonatal Infant Pain Scale pain score of the newborn were recorded by the researcher in the breastfeeding, swaddling and holding, skin-to skin-contact groups, 2 minutes before the heel lance, 10 seconds during the heel lance, and 2 minutes after the heel lance was completed. The lowest score obtained from the scale is 0, and the highest score is 7. A high scale score indicates a high level of pain in the newborn. The scoring of Neonatal Infant Pain Scale ranges from 0-7 points and 0-2 points indicate no pain, 3-4 points indicate moderate pain, >4 points indicate high levels of pain.
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 4 Apr 2023.
- Derived from this study: PubMed 40075464Karga Yilmaz T, Yavuz B. Comparison of different methods for reducing pain during a heel lance in newborns: a randomized trial. Ital J Pediatr. 2025 Mar 12;51(1):73. doi: 10.1186/s13052-025-01916-w.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breastfeeding, skin to skin contact and swaddling and holding in people with Pain, run by Kutahya Health Sciences 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 9 inclusion and 7 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 4 Apr 2023. 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?
Determination of pain scores according to measurement times; before the heel lance procedure, the newborn was 5 minutes after breastfeeding, swaddling and holding, skin-to-skin contact. (time frame: through study completion, an average of 6 month). 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 NCT05797532, which also lists 1 linked publication.
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 4 Apr 2023.