Nursing CariesNCT05220930
Foot Bath for Heel Warming Before Heel Lance
A study testing Foot bath for heel warming and Ineffective heel warming with thermofor in people with Nursing Caries, run by Isparta University of Applied Sciences at 1 site in Turkey (Türkiye).
Trial summary
Foot bath is a simple warm application method that creates a feeling of comfort and positive effects on health have been reported in the literature. There are studies reporting the benefits of footbath for different groups. 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?
- Foot bath for heel warming and Ineffective heel warming with thermofor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 May 2022to 21 Sep 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 a Foot Bath Before Capillary Heel Blood Sampling on Pain and Procedure Time in Neonates: A Randomized Clinical Trial
Foot bath is a simple warm application method that creates a feeling of comfort and positive effects on health have been reported in the literature. There are studies reporting the benefits of footbath for different groups. However, no study has been found in the literature investigating the effect of foot bath for heel warming before heel stick procedure on pain, and procedure time. Foot bath to be applied during heel blood collection is a cost-effective and easy-to-apply method. This study aims to determine the effect of foot bath for heel warming before heel stick procedure on pain, and procedure time in healthy term newborns.
Read the detailed description
Aim: This study aimed to determine the effect of foot baths applied before capillary heel blood sampling for newborn on pain level and procedure duration in term newborns.
Method: This study was planned as a randomized controlled, experimental, 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 size of the study was calculated based on the first hypothesis of the study with the G*Power 3.1 program. The sample of the study was determined as 80 healthy term newborn (40 control, 40 intervention).
Intervention: In this study, ineffective heel warming with thermofor will be applied to the control group and foot bath for heel warming will be applied to the intervention group.
Data collection instruments: Newborn Information Form (NIF), and NIPS (Neonatal Infant Pain Scale) will be used to collect data.
Data collection: In this study, the effectiveness of the intervention was pre-intervention/pre-evaluation (T1); It will be evaluated at four measurement points during the procedure (T2); 1 minute after the procedure (T3); and 5 minutes after the procedure (T4). Measurement points were determined in accordance with the literatüre. Heel blood collection will be video-recorded from the pre-evaluation stage (one minute before the intervention) until the 5th minute after the procedure. The video recording will be monitored by two independent evaluators who do not know the purpose of the study, and the NIPS scores at the measurement points and the processing time will be recorded.
- Conditions
- Nursing Caries
- Being tested
- Foot bath for heel warming, Ineffective heel warming with thermofor
- Keywords
- Foot bath, Heel warming, Heel Lance, Newborn, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot bath for heel warmingOther
In this study, in line with the literature, the attempt to apply heat with a foot bath will be carried out by immersing both legs of the newborn in a basin filled with 15-20 cm of water at 38-40C, 5 minutes before the heel blood collection, starting just below the knee level. The intervention will be applied while the newborn is held in an upright position on his mother's lap.
Ineffective heel warming with thermoforOther
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 |
|---|---|---|
| Foot bath for heel warming group | Experimental | In this study, in line with the literature, the attempt to apply heat with a foot bath will be carried out by immersing both legs of the newborn in a basin filled with 15-20 cm of water at 38-40C, 5 minutes before the heel blood collection, starting just below the knee level. The intervention will be applied while the newborn is held in an upright position on his mother's lap. Before piercing the heel, the heel will be wiped with a blanket and dried. After the intervention, blood collection from the heel will be performed by following the standard procedure steps that are routinely applied in the service. Receives: Other: Foot bath for heel warming |
| 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 |
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 two independent evaluators who do not know the purpose of the study, and the processing time will be recorded.
Measured: During the procedure
Secondary outcomes (1)
NIPS (Neonatal Infant Pain Scale)
The NIPS (Neonatal Infant Pain Scale) was developed by Lawrence et al. in 1993 and tr into translated into Turkish by Akdovan in 1999 to assess pain. This scale consists of five behavioral indicators including facial expression, leg, movement, arm movement, crying and wakefulness, and one physiological indicator of respiratory rhythm. Total scores range from 0 to Higher scores show that the intensity of pain is higher. The internal consistency of NIPS was reported to be 0.95 before the transaction, 0.87 during the transaction, and 0.88 after the transaction. According to a study conducted by Akdovan et al. in 1999, the internal consistency coefficient of this scale using Cronbach's alpha was found to be between 0.83 and 0.86.
Measured: Pre-intervention/pre-evaluation (T1); during the procedure (T2); 1 minute after the procedure (T3); and 5 minutes after the procedure (T4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start11 May 2022
- Primary completion21 Sep 2022
- Study completion21 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isparta University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Akdeniz University
- Responsible party
- Sponsor
- Investigators
- Fahriye PAZARCIKCI, PhD, Study director, Isparta University of Applied SciencesAyla KAYA, PhD, Study chair, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220930
- Sponsor's protocol ID
- IspartaUASNursingCare
- Status last verified
- Jan 2022
- First submitted
- 12 Jan 2022
- Last updated
- 3 Feb 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 24476226Unal C, Welcome MO, Salako M, Abdullahi F, Abubakar NM, Pereverzev VA, Hartiningsih SS, Dane S. The effect of foot reflexotherapy on the dynamics of cortical oscillatory waves in healthy humans: An EEG study. Complement Ther Med. 2018 Jun;38:42-47. doi: 10.1016/j.ctim.2018.03.006. Epub 2018 Mar 20.
PubMed 29857878
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Foot Bath Before Capillary Heel Blood Sampling on Pain and Procedure Time in Neonates: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05220930
- Acronym / sponsor ID
- IspartaUASNursingCare
- Conditions
- Nursing Caries
- Keywords
- Foot bath, Heel warming, Heel Lance, Newborn, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Isparta University of Applied SciencesUniversity, hospital or other
- Collaborators
- Akdeniz University
- Study start
- 11 May 2022 (actual)
- Primary completion
- 21 Sep 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 2 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.
Foot bath is a simple warm application method that creates a feeling of comfort and positive effects on health have been reported in the literature. There are studies reporting the benefits of footbath for different groups. However, no study has been found in the literature investigating the effect of foot bath for heel warming before heel stick procedure on pain, and procedure time. Foot bath to be applied during heel blood collection is a cost-effective and easy-to-apply method. This study aims to determine the effect of foot bath for heel warming before heel stick procedure on pain, and procedure time in healthy term newborns.
Detailed description
Aim: This study aimed to determine the effect of foot baths applied before capillary heel blood sampling for newborn on pain level and procedure duration in term newborns.
Method: This study was planned as a randomized controlled, experimental, 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 size of the study was calculated based on the first hypothesis of the study with the G*Power 3.1 program. The sample of the study was determined as 80 healthy term newborn (40 control, 40 intervention).
Intervention: In this study, ineffective heel warming with thermofor will be applied to the control group and foot bath for heel warming will be applied to the intervention group.
Data collection instruments: Newborn Information Form (NIF), and NIPS (Neonatal Infant Pain Scale) will be used to collect data.
Data collection: In this study, the effectiveness of the intervention was pre-intervention/pre-evaluation (T1); It will be evaluated at four measurement points during the procedure (T2); 1 minute after the procedure (T3); and 5 minutes after the procedure (T4). Measurement points were determined in accordance with the literatüre. Heel blood collection will be video-recorded from the pre-evaluation stage (one minute before the intervention) until the 5th minute after the procedure. The video recording will be monitored by two independent evaluators who do not know the purpose of the study, and the NIPS scores at the measurement points 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
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Foot bath for heel warming group | Experimental | Other: Foot bath for heel warmingIn this study, in line with the literature, the attempt to apply heat with a foot bath will be carried out by immersing both legs of the newborn in a basin filled with 15-20 cm of water at 38-40C, 5 minutes before the heel blood collection, starting just below the knee level. The intervention will be applied while the newborn is held in an upright position on his mother's lap. Before piercing the heel, the heel will be wiped with a blanket and dried. After the intervention, blood collection from the heel 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 thermoforIneffective 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 |
|---|---|---|
| Foot bath for heel warmingIn this study, in line with the literature, the attempt to apply heat with a foot bath will be carried out by immersing both legs of the newborn in a basin filled with 15-20 cm of water at 38-40C, 5 minutes before the heel blood collection, starting just below the knee level. The intervention will be applied while the newborn is held in an upright position on his mother's lap. | Other | Foot bath for heel warming group |
| Ineffective heel warming with thermoforIneffective 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 two independent evaluators who do not know the purpose of the study, and the processing time will be recorded.
1 secondary outcome
NIPS (Neonatal Infant Pain Scale)
Time frame: Pre-intervention/pre-evaluation (T1); during the procedure (T2); 1 minute after the procedure (T3); and 5 minutes after the procedure (T4).
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 3 Feb 2023.
- Results publication: 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.
- Results publication: PubMed 29857878Unal C, Welcome MO, Salako M, Abdullahi F, Abubakar NM, Pereverzev VA, Hartiningsih SS, Dane S. The effect of foot reflexotherapy on the dynamics of cortical oscillatory waves in healthy humans: An EEG study. Complement Ther Med. 2018 Jun;38:42-47. doi: 10.1016/j.ctim.2018.03.006. Epub 2018 Mar 20.
- 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, PhD study director
Isparta University of Applied Sciences
Ayla KAYA, PhD study chair
Akdeniz 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 Foot bath for heel warming and Ineffective heel warming with thermofor 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 3 Feb 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 NCT05220930, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.