Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05797532
Status:
COMPLETED
Last Update Posted:
2023-04-04
First Post:
2022-12-21
Brief Title:
Comparison of Different Methods for Reducing Pain in Heel Blood in Newborns
Sponsor:
Kutahya Health Sciences University
Organization:
Kutahya Health Sciences University
Study Overview
Official Title:
Comparison of Different Methods for Reducing Pain in Heel Blood in Newborns
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 081 - 099 at the alpha 005 significance level and the effect size was between 002 and 068
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 081 - 099 at the alpha 005 significance level and the effect size was between 002 and 068
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None