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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fawzia El-Sayed Abusaad, Professor of pediatric Nursing | Faculty of Nursing - Mansoura University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansura University Children's Hospital | Al Mansurah | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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 | ||
| 39129083 | Background | Iyi Z, Isler A, Ozer 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. |
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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.
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| 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. |
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| 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. |
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