NCT05797532

Comparison of Different Methods for Reducing Pain in Heel Blood in Newborns

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Kutahya Health Sciences University · Academic / Other
• Sex: All
• Age: 24 Hours – 36 Hours
• Healthy volunteers: Accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
OTHER	breastfeeding	The NIPS (Neonatal Infant Pain Scale) pain score, heart rate and oxygen saturation of the newborn were recorded by the researcher in the study group, 2 minutes before the heel lance, 10 seconds during the heel lance, and 2 minutes after the heel lance was completed. In order to determine the crying time of newborns in all three study groups, the voice recorder and stopwatch were turned on two minutes before and 2 minutes after the heel lance.
OTHER	skin to skin contact	The NIPS (Neonatal Infant Pain Scale) pain score, heart rate and oxygen saturation of the newborn were recorded by the researcher in the study group, 2 minutes before the heel lance, 10 seconds during the heel lance, and 2 minutes after the heel lance was completed. In order to determine the crying time of newborns in all three study groups, the voice recorder and stopwatch were turned on two minutes before and 2 minutes after the heel lance.
OTHER	swaddling and holding	The NIPS (Neonatal Infant Pain Scale) pain score, heart rate and oxygen saturation of the newborn were recorded by the researcher in the study group, 2 minutes before the heel lance, 10 seconds during the heel lance, and 2 minutes after the heel lance was completed. In order to determine the crying time of newborns in all three study groups, the voice recorder and stopwatch were turned on two minutes before and 2 minutes after the heel lance.

Timeline

• Start date: 2019-11-18
• Primary completion: 2020-05-31
• Completion: 2020-05-31
• First posted: 2023-04-04
• Last updated: 2023-04-04

Locations

1 site across 1 country: Turkey (Türkiye)