1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [aiswarya11496@gmail.com].
   


6. For how long will this data be available start date provided 21-01-2027 and end date provided 21-12-2030?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

The title of my study is Comparative study of Neonatal Pain During Heel Prick Using an Automatic Lancet Versus 26 Gauge Needle A Randomized Controlled Trial

Aim of the study is to compare the intensity of pain experienced by neonates during heel prick  performed using an automatic lancet versus a 26 gauge needle using a validated pain scale  NIPS SCORE in order to determine the more effective method for minimizing procedural pain in newborns

Primary objective is to compare the pain response in neonates during heel prick using an automatic lancet versus a 26G Needle

Secondary objectives include assessment of physiological factors such as heart rate oxygen saturation before during and after the procedure   evaluate the incidence of local complications like bruising bleeding duration skin trauma associated with each method and   access procedural efficiency

Sampling technique is STRATIFIED RANDOMIZATION

Sample size is 126 Methodology is after applying inclusion and exclusion criteria First stratification done on the basis of gestational age TERM or PRETERM

BY SNOSE method allocating neonates into groups

Group 1 Heel prick using Automatic lancet

Group 2 Heel prick using 26G needle

Automatic lancet will be set at a depth of 1mm for term and 0.85mm for preterm neonates

Choose the medial or lateral plantar surface of heel avoiding central area to prevent injury to calcaneus

Clean the selected area with spirit cotton and allow area to dry

Perform the heel prick by holding the needle or lancet at 90 degrees

5 minutes video recording of the procedure will be taken without showing the instrument used

Video will be analysed by thesis guide and pain in neonates will be scored using NIPS scoring system

Secondary objectives like procedure time analysis tissue injury physiological parameters like SpO2 and Heart rate is measured simultaneously

Video captured such that the person assessing NIPS score is not able to see the instrument used for heel prick thereby assuring blinding

Video anonymity cannot be implemented as facial expression is essential for NIPS scoring

Data protected by ensuring access to videos only by the primary investigator and  score accessor

Data will be digitized using Excel and analysed using SPSS v25