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临床试验/NCT07407881
NCT07407881进行中(未招募)不适用

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

Mansoura University1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年7月25日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
108
试验地点
1
主要终点
Pain Intensity

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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 .

排除标准

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

研究组 & 干预措施

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.

干预措施: Manual pressure applied at injection site during insulin injection to reduce pain (Other)

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.

干预措施: Shotblocker (Device)

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.

干预措施: Control group stander care (Other)

结局指标

主要结局

Pain Intensity

时间窗: 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.

Pain Intensity

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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