Actively Recruiting
Effect of Facilitated Tucking and Gentle Human Touch on Procedural Pain in Neonates: A Randomized Control Trial
Led by Shifa Tameer-e-Millat University · Updated on 2024-08-20
159
Participants Needed
2
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate how two non-drug methods, facilitated tucking and gentle human touch, affect procedural pain in newborn babies up to 28 days old. The trial is a randomized control study designed to understand pain relief during medical procedures for neonates. Pain levels will be measured using the Neonatal Infant Pain Scale to assess the effectiveness of these interventions. The study includes three groups: one receiving facilitated tucking, where the baby is gently positioned for comfort; another receiving gentle human touch, which involves caressing the baby's head; and a usual care group without these additional interventions. These methods will be applied during an arterial prick procedure, a common but painful medical test for newborns. Participants will be monitored before, during, and three minutes after the arterial prick using video recordings to score pain levels. Researchers will collect demographic information and use an independent assistant to evaluate pain scores. The study runs from May to November 2024 and involves careful observation to understand how these non-pharmacological approaches may help manage pain in the neonatal intensive care setting.
CONDITIONS
Brief Title
Effect of Facilitated Tucking and Gentle Human Touch on Procedural Pain Among Neonates
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Both term and preterm neonates
- APGAR scores of at least 6 at one minute and 8 at five minutes
- Admitted to the Neonatal Intensive Care Unit
- Undergoing arterial prick for the first time
You will not qualify if you...
- Documented birth asphyxia
- Congenital anomalies
- Neurological diagnosis
- Ventilated with paralysis
- Extremely premature newborns born before 28 weeks gestation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedural intervention
Participants receive either facilitated tucking, gentle human touch, or usual care during arterial prick to assess procedural pain relief.
1 visit (in-person)
Trial Site Locations
Total: 2 locations
1
Pakistan Institute of Medical Sciences
Islamabad, Pakistan, 44000
Actively Recruiting
2
Shifa Tameer E Millat University
Islamabad, Pakistan, 44000
Not Yet Recruiting
Research Team
N
Nazma Hamid, MSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Frequently Asked Questions
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