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NCT Number: NCT07407881

Shot Blocker and Manual Pressure Application

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Injection Pain Prevention

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansura University Children's Hospital

Al Mansurah, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Manual pressure technique

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.

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 12, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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