Shot Blocker and Manual Pressure Application

NCT07407881 | Active Not Recruiting DMC

• 1 other identifier: Shotblocker and manual pressur
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Injection Pain Prevention

Keywords

Manual pressure and shotblocker

Outcome Measures

Primary Outcomes (2)

• Pain Intensity

  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

  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

Study Arms (3)

Arm 1: Manual Pressure

EXPERIMENTAL

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

Arm 2 : shotblocker

EXPERIMENTAL

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

Arm 3: Control group

ACTIVE COMPARATOR

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

Interventions

Manual pressure applied at injection site during insulin injection to reduce pain OTHER

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.

Also known as: Manual pressure technique

Arm 1: Manual Pressure

Shotblocker DEVICE

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.

Arm 2 : shotblocker

Control group stander care OTHER

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.

Arm 3: Control group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 .

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansura University Children's Hospital

Al Mansurah, Egypt

Location

Related Publications (2)

• 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

  BACKGROUND

• 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.

  BACKGROUND

Study Officials

• Fawzia El-Sayed Abusaad, Professor of pediatric Nursing

  Faculty of Nursing - Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 12, 2026
• Study Start: July 25, 2025
• Primary Completion: October 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)