A Three-Arm Randomized Controlled Trial to compare the effectiveness of Yakson Touch Therapy versus Gentle Human Touch versus standard care on pain and physiological parameters during heel lancing procedure in neonates admitted in NICU at GGSMCH,Faridkot,Punjab.
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Ms Navpreet Kaur
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Pain assessment using standardized scale(Neonatal Infant Pain Scale-NIPS) during heel lancing procedure.
Overview
Brief Summary
The study will be conducted to compare the effectiveness of yakson touch therapy versus gentle human touch versus standard care on pain and physiological parameters during heel lancing procedure in neonates admitted in NICU at GGSMCH, Faridkot, Punjab. The main aim of the study to compare the effectiveness of yakson touch therapy versus gentle human touch versus standard care on pain and physiological parameters in neonates admitted in NICU at GGSMCH, Faridkot, Punjab. The quantitative research approach will be used to carry out randomized control trial. The simple random sampling technique will be 72 neonates randomly allocated by SNOSE method (Group A=24, Group B=24, Group C=24) will be selected based on inclusion/exclusion criteria. The tool will consist of demographic data sheet and Neonatal Infant Pain Scale (NIPS) to assess the level of pain.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 1.00 Day(s) to 28.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Neonates undergoing a heel lancing procedure (blood sugar monitoring).
- •2.Neonates who will be having the first prick on heel.
- •3.Neonates who will be conscious (able to respond painful stimuli).
- •Neonates whose parents will be willing to participate.
Exclusion Criteria
- •1.Neonates who will critically ill having RDS ( on ventilator or CPAP), congenital anomaly, Intraventricular hemorrhage, History of surgery or inflammation of heel.
- •2.Neonates who will be under any sedatives/ anticonvulsant drugs.
- •3.Neonates will be undergoing heel lance procedure repeated within 4 hours.
Outcomes
Primary Outcomes
Pain assessment using standardized scale(Neonatal Infant Pain Scale-NIPS) during heel lancing procedure.
Time Frame: 3 minutes
Secondary Outcomes
- Physiological parameters(Heart rate,Respiratory rate,saturation)((Time 0 minutes)Baseline data before the intervention & immediately after the intervention(Time 3 minutes))
Investigators
Ms Navpreet Kaur
Baba Farid University of Health Sciences(Faridkot)(Faridkot)