Shot Blocker and Manual Pressure Application

February 6, 2026 updated by: Mansoura University

Effectiveness of Manual Pressure Application Versus Shotblocker on Reducing Insulin Injection Pain Among Children With Type 1 Diabetes Mellitus

Aim of my intervention to test the effectiveness of using the manual pressure application and shotblocker for relief insulin injection pain in children with type 1 diabetes mellitus

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Al Mansurah, Egypt
        • Mansura University Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Their age ranging between 6 to12 years old of both genders. Diagnosed with Type 1 Diabetes Mellitus (new and old diagnosed). Receiving subcutaneous insulin injection .

Exclusion Criteria:

  • Having lipodystrophy, infection and nerve damage at injection site. Tooking analgesic within the least 6 hours. Refusing to participate.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Manual Pressure
Manual Pressure Application (MPA) is a cost-free, nonpharmacological method that is easily learned and requires no equipment or preparation use for reduce insulin injection pain among children with type 1 diabetes mellitus .Manual therapy interventions (also described as force-based manipulations) refer to the passive application of mechanical force to the outside of the body with therapeutic effect. Right thumb pressure was be applied to the appropriate inject site of insulin therapy for 10 seconds, then immediately inject the insulin. The children's pain intensity during and immediately after insulin injection scores will be rated by the children themselves and a researcher using the Wong-Baker FACES Pain Rating Scale.
Other: Manual pressure applied at injection site during insulin injection to reduce pain
Right thumb pressure was be applied to the appropriate inject site of insulin therapy for 10 seconds, then immediately inject the insulin. The children's pain intensity during and immediately after insulin injection scores will be rated by the children themselves and a researcher using the Wong-Baker FACES Pain Rating Scale.
Other Names:
  • Manual pressure technique
Experimental: Arm 2 : shotblocker
The Shotblocker is a low-technology, cost-effective small flat C-shaped plastic flexible tool with multiple short, blunt protrusions on one side that is a non-invasive and drug-free method. This tool is applied to the skin to create signal sensory distraction surrounding the injection site, resulting in inhibition of pain signals during injection. Apply the shotblocker and press firmly with its multiple blunt protrusions on contact points of skin. After that, give an insulin injection through the central opening. The children's pain intensity during and immediately after insulin injection scores will be rated by the children themselves and a researcher using the Wong-Baker FACES Pain Rating Scale.
Device: Shotblocker
Apply the shotblocker and press firmly with its multiple blunt protrusions on contact points of skin. After that, give an insulin injection through the central opening. The children's pain intensity during and immediately after insulin injection scores will be rated by the children themselves and a researcher using the Wong-Baker FACES Pain Rating Scale.
Active Comparator: Arm 3: Control group
The children's pain intensity scores during and immediately after insulin injection will be rated by the children themselves and a researcher by using the Wong-Baker FACES Pain Rating Scale to control the group who don't receive the previous method of intervention and receive routine care only.
Other: Control group stander care
The children's pain intensity scores during and immediately after insulin injection will be rated by the children themselves and a researcher by using the Wong-Baker FACES Pain Rating Scale to control the group who don't receive the previous method of intervention and receive routine care only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: during and immediately after insulin injection
The children's pain intensity during and immediately after insulin injection scores will be rated by the children themselves and a researcher using the Wong-Baker FACES Pain Rating Scale.
during and immediately after insulin injection
Pain Intensity
Time Frame: Immediately after insulin injection
The children's pain intensity during and immediately after insulin injection scores will be rated by the children themselves and a researcher using the Wong-Baker FACES Pain Rating Scale.
Immediately after insulin injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Director: Fawzia El-Sayed Abusaad, Professor of pediatric Nursing, Faculty of Nursing - Mansoura University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • EL-mahdy, E. S. R., El-khedr, S. M., Elrifaey, S. M., & Elaraby, M. E. (2023). Effect of Shot Blockers versus Buzzy Bee Distractor on Relieving Pain and Anxiety Level during Insulin Injection among Children with Type I Diabetes. Tanta Scientific Nursing Journal, 29(2), 32-49. https://doi.org/10.21608/tsnj.2023.298374
  • İyi Z, İşler A, Özer Z. Effectiveness of ShotBlocker application on reducing the pain of needle-related procedures in children: A systematic review and meta-analysis. J Pediatr Nurs. 2024 Sep-Oct;78:e438-e447. doi: 10.1016/j.pedn.2024.08.006. Epub 2024 Aug 10. PMID: 39129083.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2025

Primary Completion (Actual)

October 30, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

February 6, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Shotblocker and manual pressur

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to ethical and privacy considerations, and because no informed consent was obtained for data sharing beyond the objectives of this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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