Clinical trial NCT05797532: Comparison of Different Methods for Reducing Pain in Heel Blood in Newborns
Official title: Comparison of Different Methods for Reducing Pain in Heel Blood in Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: heel lance
breastfeeding
swaddling and holding
skin to skin contact
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 90
Sex: ALL
Minimum age (years): 24
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of three different methods
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

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
* No previous invasive intervention other than vitamin K and hepatitis B vaccine.
* 1st and 5th minute Apgar score ≥7
* Parents have given written consent.

Exclusion Criteria:

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.

Primary outcomes:
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.
timeFrame: through study completion, an average of 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Sciences University
Study officials:
References: