Pain ManagementNCT06847048
Nonpharmacological Methods in Heel Stick Pain
A study testing Thermophore pad warming group and Warm towel warming group in people with Pain Management and Newborn Pain, run by Diler Yilmaz at 1 site in Turkey (Türkiye).
Trial summary
In the present study, the randomized controlled and experimental design is used because it was aimed to determine the effects of two different warming methods (warming with a thermophore heating pad and warming with a warm towel) performed before heel prick intervention on pain levels and duration of crying in healthy… Read more about this study
- Who is it for?
- Ages 1 day to 2 daysHealthy volunteers can take part
- Conditions the study is for
- Pain Management, Newborn Pain
- What is being tested?
- Thermophore pad warming group and Warm towel warming group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2017to 1 Feb 2018
- 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 2 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Having been born at 38-42 weeks of gestation,
- having a birth weight of 2500 g and above,
- having a 5-min APGAR score of 7 and above,
- having stable health,
- having been fed within an hour before the intervention, being calm and not crying before the intervention,
- having a postnatal age of 24-72 hours, and
- undergoing heel prick for the first time
Who cannot join
- Parents with any mental problems
- Infants with any chronic disease and congenital anomalies.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bandırma Onyedi Eylül University
Bandirna, Balıkesir, 10200
About this study
Official title: Effects of Using Various Heel-warming Methods Such As Warm Towel Warming and a Thermophore Heating Pad Warming Before Heel Prick on Newborns' Pain Level and Duration of Crying
In the present study, the randomized controlled and experimental design is used because it was aimed to determine the effects of two different warming methods (warming with a thermophore heating pad and warming with a warm towel) performed before heel prick intervention on pain levels and duration of crying in healthy term newborns.
Study hypotheses are; Hypothesis 1. Using the thermophore pad warming method in newborns before heel prick reduces the newborn's pain level.
Read more
Hypothesis 2. Using the warm towel warming method in newborns before heel prick reduces the newborn's pain level.
Hypothesis 3. Using the thermophore pad warming method in newborns before heel prick reduces the duration of crying.
Hypothesis 4. Using the warm towel warming method in newborns before heel prick reduces the duration of crying
Read the detailed description
Heel prick, intervention performed to take blood sample from the heel, which is frequently performed in newborns, is a more painful intervention than are other methods of taking blood samples. In several studies, it has been indicated that the use of various non-pharmacological methods such as sucrose administration, breastfeeding, skin-to-skin care, acupressure, swaddling, positioning, non-nutritive sucking, foot reflexology, vibration, laser acupuncture, warming the baby's heel reduce infants' pain during heel prick.
This study is a prospective, randomized and controlled trial. In this study aim, was aimed at determining the effects of two different heel warming methods (warming with a thermophore heating pad and warming with a warm towel) performed before heel prick on healthy term newborns' pain levels and duration of cryingin newborns will be examined.
The minimum number of newborns to be included in the study was calculated as 150 using the G*Power (3.1. 9.7) program (margin of error: 5%, confidence interval: 0.95, power: 0.80). The 150 newborns in the sample were randomly assigned into the following three groups in equal numbers via an internet-based program (http://www.randomizer.org): control group (n = 50), thermophore-warming group (n = 47) and warm towel-warming group (n = 50).
Data Collection Tools To collect the study data, the "Descriptive Information Form", "Follow-up Form", and "Neonatal Infant Pain Scale" were used.
- Conditions
- Pain Management, Newborn Pain
- Being tested
- Thermophore pad warming group, Warm towel warming group, Control group
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermophore pad warming groupProcedure or surgery
Thermophore pad waa using heel warming
Warm towel warming groupProcedure or surgery
In this group, to warm the heel, the heel area where the blood would be taken was wrapped with a previously heated towel before heel prick.
Control groupOther
in this group, heel prick intervention was performed in line with the routine interventions of the clinic.
| Study group | Role | What they receive |
|---|---|---|
| Thermophore pad warming group | Experimental | In the literature, (Lehmann, 1990; Shu et al., 2014), it is recommended that the heel should be warmed at a temperature ranging between 40°C and 45°C to increase blood flow before the heel prick test was performed. During the intervention, the newborn was wrapped with its own blanket leaving the extremity to be treated uncovered. Then, the thermophore heating pad filled with 40°C water was used to warm the sole of the foot for approximately 5 minutes just before the intervention. Attention was paid to prevent the thermophore heating pad from touching other parts of the baby's skin. Receives: Procedure: Thermophore pad warming group |
| Warm towel warming group | Experimental | In this group, to warm the heel, the heel area where the blood would be taken was wrapped with a previously heated towel before heel prick. A clean cotton towel was used to warm the newborns' heels. Before the intervention, to warm the towel, it was wrapped in a thermophore pad filled with water at a temperature of approximately 40°C-45°C. The foot area and the heel of the newborn where the blood would be taken were wrapped with a warm towel for 3-4 minutes before heel prick was performed. Receives: Procedure: Warm towel warming group |
| Control group | Experimental | In the newborns in this group, heel prick intervention was performed in line with the routine interventions of the clinic. The baby was wrapped in a blanket leaving the foot from which the blood sample would be taken unwrapped. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Infant Pain Scale (NIPS)
Neonatal Infant Pain Scale: NIPS was developed by Lawrence et al. (1993)21 to evaluate behavioral and physiologic pain responses of preterm and term infants. The scale was adapted to Turkish by Akdovan (1999)22. In the present study, NIPS was used to evaluate the interventional (procedural) pain level of newborns. The scale consists of five behavioral (facial expressions, crying, wakefulness, arm and leg movements) and a physiologic (breathing) signs; 0-2 points are given to the crying indicator, 0-1 points are given to other indicators, and the total score is between 0 and 7. High scores indicate that the severity of pain is excessive.
Measured: Pain levels of the newborns evaluated during the procedures
Secondary outcomes (1)
Total criying time
Duration of crying were recorded.
Measured: The time of the procedure was measured from the beginning to the end of the heel stick procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start1 Mar 2017
- Primary completion1 Jan 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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
- Model description
- Prospective, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diler Yilmaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Diler Yilmaz, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847048
- Sponsor's protocol ID
- BANU-D-YILMAZ-003
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available. I did not find It appropriate to share it.
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Using Various Heel-warming Methods Such As Warm Towel Warming and a Thermophore Heating Pad Warming Before Heel Prick on Newborns' Pain Level and Duration of Crying
- ClinicalTrials.gov ID
- NCT06847048
- Acronym / sponsor ID
- BANU-D-YILMAZ-003
- Conditions
- Pain Management, Newborn Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Diler YilmazUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 26 Feb 2025 (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.
In the present study, the randomized controlled and experimental design is used because it was aimed to determine the effects of two different warming methods (warming with a thermophore heating pad and warming with a warm towel) performed before heel prick intervention on pain levels and duration of crying in healthy term newborns.
Study hypotheses are; Hypothesis 1. Using the thermophore pad warming method in newborns before heel prick reduces the newborn's pain level.
Hypothesis 2. Using the warm towel warming method in newborns before heel prick reduces the newborn's pain level.
Hypothesis 3. Using the thermophore pad warming method in newborns before heel prick reduces the duration of crying.
Hypothesis 4. Using the warm towel warming method in newborns before heel prick reduces the duration of crying
Detailed description
Heel prick, intervention performed to take blood sample from the heel, which is frequently performed in newborns, is a more painful intervention than are other methods of taking blood samples. In several studies, it has been indicated that the use of various non-pharmacological methods such as sucrose administration, breastfeeding, skin-to-skin care, acupressure, swaddling, positioning, non-nutritive sucking, foot reflexology, vibration, laser acupuncture, warming the baby's heel reduce infants' pain during heel prick.
This study is a prospective, randomized and controlled trial. In this study aim, was aimed at determining the effects of two different heel warming methods (warming with a thermophore heating pad and warming with a warm towel) performed before heel prick on healthy term newborns' pain levels and duration of cryingin newborns will be examined.
The minimum number of newborns to be included in the study was calculated as 150 using the G*Power (3.1. 9.7) program (margin of error: 5%, confidence interval: 0.95, power: 0.80). The 150 newborns in the sample were randomly assigned into the following three groups in equal numbers via an internet-based program (http://www.randomizer.org): control group (n = 50), thermophore-warming group (n = 47) and warm towel-warming group (n = 50).
Data Collection Tools To collect the study data, the "Descriptive Information Form", "Follow-up Form", and "Neonatal Infant Pain Scale" were used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Prospective, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Thermophore pad warming group | Experimental | Procedure: Thermophore pad warming groupIn the literature, (Lehmann, 1990; Shu et al., 2014), it is recommended that the heel should be warmed at a temperature ranging between 40°C and 45°C to increase blood flow before the heel prick test was performed. During the intervention, the newborn was wrapped with its own blanket leaving the extremity to be treated uncovered. Then, the thermophore heating pad filled with 40°C water was used to warm the sole of the foot for approximately 5 minutes just before the intervention. Attention was paid to prevent the thermophore heating pad from touching other parts of the baby's skin. |
| Warm towel warming group | Experimental | Procedure: Warm towel warming groupIn this group, to warm the heel, the heel area where the blood would be taken was wrapped with a previously heated towel before heel prick. A clean cotton towel was used to warm the newborns' heels. Before the intervention, to warm the towel, it was wrapped in a thermophore pad filled with water at a temperature of approximately 40°C-45°C. The foot area and the heel of the newborn where the blood would be taken were wrapped with a warm towel for 3-4 minutes before heel prick was performed. |
| Control group | Experimental | Other: Control groupIn the newborns in this group, heel prick intervention was performed in line with the routine interventions of the clinic. The baby was wrapped in a blanket leaving the foot from which the blood sample would be taken unwrapped. |
Who may qualify
- Ages
- 1 day to 2 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Having been born at 38-42 weeks of gestation,
- having a birth weight of 2500 g and above,
- having a 5-min APGAR score of 7 and above,
- having stable health,
- having been fed within an hour before the intervention, being calm and not crying before the intervention,
Key exclusion criteria (2 listed)
- Parents with any mental problems
- Infants with any chronic disease and congenital anomalies.
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 |
|---|---|---|
| Thermophore pad warming groupThermophore pad waa using heel warming | Procedure or surgery | Thermophore pad warming group |
| Warm towel warming groupIn this group, to warm the heel, the heel area where the blood would be taken was wrapped with a previously heated towel before heel prick. | Procedure or surgery | Warm towel warming group |
| Control groupin this group, heel prick intervention was performed in line with the routine interventions of the clinic. | Other | Control group |
Primary outcome
Neonatal Infant Pain Scale (NIPS)
Time frame: Pain levels of the newborns evaluated during the procedures
Neonatal Infant Pain Scale: NIPS was developed by Lawrence et al. (1993)21 to evaluate behavioral and physiologic pain responses of preterm and term infants. The scale was adapted to Turkish by Akdovan (1999)22. In the present study, NIPS was used to evaluate the interventional (procedural) pain level of newborns. The scale consists of five behavioral (facial expressions, crying, wakefulness, arm and leg movements) and a physiologic (breathing) signs; 0-2 points are given to the crying indicator, 0-1 points are given to other indicators, and the total score is between 0 and 7. High scores indicate that the severity of pain is excessive.
1 secondary outcome
Total criying time
Time frame: The time of the procedure was measured from the beginning to the end of the heel stick procedure.
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 26 Feb 2025.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available. I did not find It appropriate to share it.
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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 Thermophore pad warming group and Warm towel warming group in people with Pain Management and Newborn Pain, run by Diler Yilmaz 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 7 inclusion and 2 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 26 Feb 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?
Neonatal Infant Pain Scale (NIPS) (time frame: Pain levels of the newborns evaluated during the procedures). 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 26 Feb 2025.