1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Anyone
   


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 (Others) -  In publication


6. For how long will this data be available start date provided 20-04-2026 and end date provided 20-01-2026?
   Response - Immediately following publication. No end date.
   


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

The main concern of the pediatric dentist is to achieve the cooperation of the child in the dental clinic during various pediatric procedures. Administering anesthesia to pediatric patients proves to be the most challenging part of the process. The real fear of the child during a pediatric procedure is painful local anesthetic (LA) injections. Reducing the fear of pain during LA injections gains the confidence of the child toward the dentist, thus achieving the cooperation of the child during treatment [Patil et al., 2021]. Over the years, topical anesthetics have been used to prepare injection sites before needle penetration. Nakanishi et al. found that the site of injection plays an essential role in the efficacy of topical anesthetic agents as they produce surface anesthesia and have a limited capacity to penetrate deep into tissues. Although the discomfort due to surface penetration is reduced, they are ineffective at greater penetration depths which are required for regional block injections such as the IANB [Choudhari et al.,2017].

 Pediatric dentists are persistently in search of techniques, which may present a more relaxing dental experience. Cryotherapy application is one of the endorsed strategies for reducing pain perception in patients that would be effective, efficient, and cost-effective. It is the application of ice or refrigerant spray on the anesthetic site to counter nerve conduction of pain from the site [Lakshmanan et al.,2021]. The use of acupuncture is a traditional Chinese medical technique for treating pain. There are various types of acupuncture techniques, out of which electro-acupuncture is one where electrical stimulation of a point with acupuncture needles is used. However, pain due to needle insertion persists. So, acupuncture needles are replaced by TENS therapy to stimulate superficial nerves for localized pain relief. With this technology, an electronic acupuncture pen has been devised, and is a non-invasive method for producing local analgesia [Deulkar et al.,2023]. Allgood defined TENS as direct stimulation of the nerves by electrical impulses of short duration and small amplitude. Shane and Kessler in 1967 first described its use in various fields related to medicines. TENS and cryotherapy work on the principle of gate control theory given by Melzack and Wall in 1965. The application of ice and TENS provides physiological as well as psychological benefits to the patients as it may distract them from focusing on their discomfort. Thus, this study was planned to evaluate the effectiveness of TENS via electronic acupuncture pen, cryotherapy, and 2% benzocaine gel to alleviate pain before LA administration in children aged 7-10 years.