Clinical trial NCT05220930: Foot Bath for Heel Warming Before Heel Lance
Official title: The Effect of a Foot Bath Before Capillary Heel Blood Sampling on Pain and Procedure Time in Neonates: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Caries
Keywords: Foot bath
Heel warming
Heel Lance
Newborn
Pain
Lead sponsor: Isparta University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Akdeniz University
First posted: 2022-02-02
Enrollment: 80
Sex: ALL
Minimum age (years): 24
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Prosedüre time measure
timeFrame: During the procedure
Secondary outcomes:
measure: NIPS (Neonatal Infant Pain Scale)
timeFrame: Pre-intervention/pre-evaluation (T1); during the procedure (T2); 1 minute after the procedure (T3); and 5 minutes after the procedure (T4).
Other outcomes:
Locations:
city: Isparta
country: Turkey
facility: Isparta University of Applied Sciences
Study officials:
affiliation: Isparta University of Applied Sciences
name: Fahriye PAZARCIKCI, PhD
role: STUDY_DIRECTOR
affiliation: Akdeniz University
name: Ayla KAYA, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: Unal 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.