Nursing CariesNCT05228366
Heel Warming With Mild and Hot Thermofor Applied Before Heel Lance
A study testing Heel warming with mild thermofor group, Heel warming with hot thermofor group and Ineffective heel warming with thermofor group in people with Nursing Caries, run by Isparta University of Applied Sciences at 1 site in Turkey (Türkiye).
Trial summary
Heel warming with thermophor during heel blood collection is a cost-effective and easy-to-apply method. In previous studies, it has been shown that applying heat to the heel reduces the pain of taking heel blood, increases comfort and shortens the procedure time and total crying time. Read more about this study
- Who is it for?
- Ages 24 to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Nursing Caries
- What is being tested?
- Heel warming with mild thermofor group, Heel warming with hot thermofor group and Ineffective heel warming with thermofor group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 May 2022to 18 Oct 2022
- 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 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Born between 38-42 gestational weeks (term newborns)
- Newborns with a birth weight of 2500-4400 grams
- Newborns with stable physiological parameters and general condition
- Newborns with vitamin K and hepatitis B vaccine in the delivery room
- Newborns with eight or more Apgar scores in the first and fifth minutes
Who cannot join
- Newborns with problems during pregnancy, labor and postpartum
- Newborns with congenital anomaly
- Newborns receiving pharmacological or non-pharmacological pain management intervention before the procedure
- Newborns with receiving oxygen therapy
- Newborns with having undergone a surgical procedure
- Newborns with sepsis or suspected sepsis
- Newborns whose parents state that they want to leave the study while the study continues
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Isparta University of Applied Sciences
Isparta, 32100
About this study
Official title: The Effect of Heel Warming With Mild and Hot Thermofor Applied Before Heel Lance on Total Crying Time and Procedure Time in Healthy Term Newborns.: A Randomized Clinical Trial
Heel warming with thermophor during heel blood collection is a cost-effective and easy-to-apply method. In previous studies, it has been shown that applying heat to the heel reduces the pain of taking heel blood, increases comfort and shortens the procedure time and total crying time. Warm aplication increases the skin surface temperature, causing proximal vasodilation, thereby accelerating blood flow and increasing blood circulation. Increased blood circulation can reduce the pressure applied to the heel of newborns, shorten the procedure time, reduce the perception of pain and increase comfort. As a result of the literature review, it is seen that there is no clarity about the temperature degrees used in heel heating. It has been seen in the literature that warming the heel before heel blood collection is often carried out as mild (34-37C) or hot (38-40C). This study aims to determine heel warming with mild (34-37C) and hot (38-40C) thermofor applied before heel lance on total crying time and procedure time in healthy term newborns.
Read the detailed description
Aim: The effect of heel warming with mild (34-37C) and hot (38-40C) thermofor applied before capillary heel blood sampling on total crying time and procedure time in term newborns.
Method: This study was planned as a randomized controlled, experimental, double-blind, single-center study. The universe of the research will be term newborns whose heel blood samples will be taken within the scope of the Newborn Screening Program (NSP) in the Isparta Şehir Hospital Gynecology and Obstetrics III Service.
The sample of the study was determined as 120 healthy term newborn (40 control, 40 intervention 1, 40 intervention 2).
Intervention: In this study, ineffective heel warming with thermofor will be applied to the control group; heel warming with mild (34-37C) thermofor will be applied to the intervention group 1; heel warming with hot (38-40C) thermofor will be applied to the intervention group 2. All newborns will breastfed from their mothers during and after the procedure.
Data collection instruments: Newborn Information Form (NIF).
Data collection: Heel blood collection will be video-recorded from the pre-evaluation stage (one minute before the intervention) until the 5th minute after the puncture heel. The video recording will be monitored by independent evaluator who do not know the purpose of the study, and the processing time will be recorded.
- Conditions
- Nursing Caries
- Being tested
- Heel warming with mild thermofor group, Heel warming with hot thermofor group, Ineffective heel warming with thermofor group
- Keywords
- Heel warming, Heel Lance, Newborn, Total crying time, Processing time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heel warming with mild thermofor groupOther
Heel warming will be applied to the newborns in the ıntervention group 1 with a thermofor containing 34-37C warm water for 5 minutes before the heel blood collection procedure. During the procedure, the general condition of the newborn and the changes in his skin will be observed closely. Heel blood collection will be performed by following the standard procedure steps that are routinely applied in the service
Heel warming with hot thermofor groupOther
Heel warming will be applied to the newborns in the ıntervention group 2 with a thermofor containing 38-40C warm water for 5 minutes before the heel blood collection procedure. During the procedure, the general condition of the newborn and the changes in his skin will be observed closely. Heel blood collection will be performed by following the standard procedure steps that are routinely applied in the service
Ineffective heel warming with thermofor groupOther
Ineffective heel warming will be applied to the newborns in the control group with a thermofor containing 28C warm water for 5 minutes before the heel blood collection procedure. During the procedure, the general condition of the newborn and the changes in his skin will be observed closely. Heel blood collection will be performed by following the standard procedure steps that are routinely applied in the service.
| Study group | Role | What they receive |
|---|---|---|
| Heel warming with mild thermofor group | Experimental | Heel warming will be applied to the newborns in the ıntervention group 1 with a thermofor containing 34-37C warm water for 5 minutes before the heel blood collection procedure. During the procedure, the general condition of the newborn and the changes in his skin will be observed closely. Heel blood collection will be performed by following the standard procedure steps that are routinely applied in the service. Receives: Other: Heel warming with mild thermofor group |
| Heel warming with hot thermofor group | Experimental | Heel warming will be applied to the newborns in the ıntervention group 2 with a thermofor containing 38-40C warm water for 5 minutes before the heel blood collection procedure. During the procedure, the general condition of the newborn and the changes in his skin will be observed closely. Heel blood collection will be performed by following the standard procedure steps that are routinely applied in the service. Receives: Other: Heel warming with hot thermofor group |
| Ineffective heel warming with thermofor group | Other | Ineffective heel warming will be applied to the newborns in the control group with a thermofor containing 28C warm water for 5 minutes before the heel blood collection procedure. During the procedure, the general condition of the newborn and the changes in his skin will be observed closely. Heel blood collection will be performed by following the standard procedure steps that are routinely applied in the service. Receives: Other: Ineffective heel warming with thermofor group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosedüre time measure
The video recording will be monitored by independent evaluator who do not know the purpose of the study, and the processing time will be recorded.
Measured: During the procedure
Secondary outcomes (1)
Total crying time
The video recording will be monitored by independent evaluator who do not know the purpose of the study, and the total crying time will be recorded.
Measured: Up to 5 minutes after the heel stick
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start11 May 2022
- Primary completion18 Oct 2022
- Study completion18 Oct 2022
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 Nursing CariesStudies 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
- 3-armed randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isparta University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fahriye PAZARCIKCI, Study director, Isparta University of Applied Sciences, Isparta, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228366
- Sponsor's protocol ID
- IspartaUASNursingCare2
- Status last verified
- Feb 2022
- First submitted
- 12 Jan 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: N/O
Publications
Shu SH, Lee YL, Hayter M, Wang RH. Efficacy of swaddling and heel warming on pain response to heel stick in neonates: a randomised control trial. J Clin Nurs. 2014 Nov;23(21-22):3107-14. doi: 10.1111/jocn.12549. Epub 2014 Jan 30.
PubMed 24476226
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Heel Warming With Mild and Hot Thermofor Applied Before Heel Lance on Total Crying Time and Procedure Time in Healthy Term Newborns.: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05228366
- Acronym / sponsor ID
- IspartaUASNursingCare2
- Conditions
- Nursing Caries
- Keywords
- Heel warming, Heel Lance, Newborn, Total crying time, Processing time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Isparta University of Applied SciencesUniversity, hospital or other
- Study start
- 11 May 2022 (actual)
- Primary completion
- 18 Oct 2022 (actual)
- Study completion
- 18 Oct 2022 (actual)
- First posted
- 8 Feb 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.
Heel warming with thermophor during heel blood collection is a cost-effective and easy-to-apply method. In previous studies, it has been shown that applying heat to the heel reduces the pain of taking heel blood, increases comfort and shortens the procedure time and total crying time. Warm aplication increases the skin surface temperature, causing proximal vasodilation, thereby accelerating blood flow and increasing blood circulation. Increased blood circulation can reduce the pressure applied to the heel of newborns, shorten the procedure time, reduce the perception of pain and increase comfort. As a result of the literature review, it is seen that there is no clarity about the temperature degrees used in heel heating. It has been seen in the literature that warming the heel before heel blood collection is often carried out as mild (34-37C) or hot (38-40C). This study aims to determine heel warming with mild (34-37C) and hot (38-40C) thermofor applied before heel lance on total crying time and procedure time in healthy term newborns.
Detailed description
Aim: The effect of heel warming with mild (34-37C) and hot (38-40C) thermofor applied before capillary heel blood sampling on total crying time and procedure time in term newborns.
Method: This study was planned as a randomized controlled, experimental, double-blind, single-center study. The universe of the research will be term newborns whose heel blood samples will be taken within the scope of the Newborn Screening Program (NSP) in the Isparta Şehir Hospital Gynecology and Obstetrics III Service.
The sample of the study was determined as 120 healthy term newborn (40 control, 40 intervention 1, 40 intervention 2).
Intervention: In this study, ineffective heel warming with thermofor will be applied to the control group; heel warming with mild (34-37C) thermofor will be applied to the intervention group 1; heel warming with hot (38-40C) thermofor will be applied to the intervention group 2. All newborns will breastfed from their mothers during and after the procedure.
Data collection instruments: Newborn Information Form (NIF).
Data collection: Heel blood collection will be video-recorded from the pre-evaluation stage (one minute before the intervention) until the 5th minute after the puncture heel. The video recording will be monitored by independent evaluator who do not know the purpose of the study, and the processing time will be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 3-armed randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Heel warming with mild thermofor group | Experimental | Other: Heel warming with mild thermofor groupHeel warming will be applied to the newborns in the ıntervention group 1 with a thermofor containing 34-37C warm water for 5 minutes before the heel blood collection procedure. During the procedure, the general condition of the newborn and the changes in his skin will be observed closely. Heel blood collection will be performed by following the standard procedure steps that are routinely applied in the service. |
| Heel warming with hot thermofor group | Experimental | Other: Heel warming with hot thermofor groupHeel warming will be applied to the newborns in the ıntervention group 2 with a thermofor containing 38-40C warm water for 5 minutes before the heel blood collection procedure. During the procedure, the general condition of the newborn and the changes in his skin will be observed closely. Heel blood collection will be performed by following the standard procedure steps that are routinely applied in the service. |
| Ineffective heel warming with thermofor group | Other | Other: Ineffective heel warming with thermofor groupIneffective heel warming will be applied to the newborns in the control group with a thermofor containing 28C warm water for 5 minutes before the heel blood collection procedure. During the procedure, the general condition of the newborn and the changes in his skin will be observed closely. Heel blood collection will be performed by following the standard procedure steps that are routinely applied in the service. |
Who may qualify
- Ages
- 24 to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Born between 38-42 gestational weeks (term newborns)
- Newborns with a birth weight of 2500-4400 grams
- Newborns with stable physiological parameters and general condition
- Newborns with vitamin K and hepatitis B vaccine in the delivery room
- Newborns with eight or more Apgar scores in the first and fifth minutes
Key exclusion criteria (7 listed)
- Newborns with problems during pregnancy, labor and postpartum
- Newborns with congenital anomaly
- Newborns receiving pharmacological or non-pharmacological pain management intervention before the procedure
- Newborns with receiving oxygen therapy
- Newborns with having undergone a surgical procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heel warming with mild thermofor groupHeel warming will be applied to the newborns in the ıntervention group 1 with a thermofor containing 34-37C warm water for 5 minutes before the heel blood collection procedure. During the procedure, the general condition of the newborn and the changes in his skin will be observed closely. Heel blood collection will be performed by following the standard procedure steps that are routinely applied in the service | Other | Heel warming with mild thermofor group |
| Heel warming with hot thermofor groupHeel warming will be applied to the newborns in the ıntervention group 2 with a thermofor containing 38-40C warm water for 5 minutes before the heel blood collection procedure. During the procedure, the general condition of the newborn and the changes in his skin will be observed closely. Heel blood collection will be performed by following the standard procedure steps that are routinely applied in the service | Other | Heel warming with hot thermofor group |
| Ineffective heel warming with thermofor groupIneffective heel warming will be applied to the newborns in the control group with a thermofor containing 28C warm water for 5 minutes before the heel blood collection procedure. During the procedure, the general condition of the newborn and the changes in his skin will be observed closely. Heel blood collection will be performed by following the standard procedure steps that are routinely applied in the service. | Other | Ineffective heel warming with thermofor group |
Primary outcome
Prosedüre time measure
Time frame: During the procedure
The video recording will be monitored by independent evaluator who do not know the purpose of the study, and the processing time will be recorded.
1 secondary outcome
Total crying time
Time frame: Up to 5 minutes after the heel stick
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 14 Mar 2023.
- Background: PubMed 24476226Shu SH, Lee YL, Hayter M, Wang RH. Efficacy of swaddling and heel warming on pain response to heel stick in neonates: a randomised control trial. J Clin Nurs. 2014 Nov;23(21-22):3107-14. doi: 10.1111/jocn.12549. Epub 2014 Jan 30.
- Individual participant dataSharing planned: No. N/O
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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.
Fahriye PAZARCIKCI study director
Isparta University of Applied Sciences, Isparta, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heel warming with mild thermofor group, Heel warming with hot thermofor group and Ineffective heel warming with thermofor group in people with Nursing Caries, run by Isparta University of Applied Sciences 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 5 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 14 Mar 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?
Prosedüre time measure (time frame: During the procedure). 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 NCT05228366, 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 14 Mar 2023.