Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT06567093
Status:
RECRUITING
Last Update Posted:
2024-08-22
First Post:
2024-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Leg and Heel Massage on Pain During Heel Blood Collection Newborns
Sponsor:
Bartın Unıversity
Organization:
Study Overview
Official Title:
Effect of Leg and Heel Massage on Pain Experienced During Heel Blood Collection and Physiological Parameters in Newborns: Randomized Controlled Study
Status:
RECRUITING
Status Verified Date:
2024-08
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:
This study was planned to evaluate the effect of leg and heel massage on newborns, the pain experienced during heel blood collection, and the effects on physiological parameters.
H1: Newborn Infants Pain Scale scores are lower in leg and heel massage group than control group.
H2: Heart rates are lower in leg and heel massage group than control group. H3: Oxygen saturation levels are higher in leg and heel massage group than control group.
H1: Newborn Infants Pain Scale scores are lower in leg and heel massage group than control group.
H2: Heart rates are lower in leg and heel massage group than control group. H3: Oxygen saturation levels are higher in leg and heel massage group than control group.
Detailed Description:
In this study, there will be two groups as the intervention (who will receive leg and heel massage) and the control group (who will receive routine care). A power analysis was performed based on the number of children in both groups, based on another study using the scales to be used in the research. According to the calculations made in the G-Power 3.1 Demo package program, when the effect size was accepted as 0.8, it was seen that at least 30 cases in each group would be sufficient for 80% power. Infants who meet the research criteria will be randomly assigned to the intervention and control groups via http://www.randomize.org/ by assigning a number to the order of arrival at the hospital. The heel blood collection will be applied to both the intervention and control groups. For children in the massage group, the massage will be applied to both legs and heels of the baby. Immediately before the procedure, each leg and heel will be massaged for three minutes. The control group will receive heel blood collection with routine care. A researcher and a nurse were employed for the heel blood collection both for the intervention and control groups. A pediatric nurse performed the heel blood collection for all infants and the other researcher helped the children to assess their pain, heart rates and Oxygen saturation. Measurements 5 minutes before the heel prick procedure, during the procedure (1st minute) and 5 minutes after the heel prick application. The heel blood collection will be performed by the same nurse both in the intervention and control groups.
Study Oversight
Has Oversight DMC:
False
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?: