Clinical trial NCT05789810: Manual Pressure and ShotBlocker to Reduce Needle-Related Pain and Fear
Official title: Effects of Applications Manual Pressure and ShotBlocker to Reduce Needle-Related Pain and Fear in Children With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Fear
Lead sponsor: Çankırı Karatekin University
Sponsor class: OTHER
Collaborators: name: Istanbul Saglik Bilimleri University
First posted: 2023-03-29
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional
Primary purpose: PREVENTION

Brief summary: This experimental, prospective, and randomized controlled study was designed to determine and compare the effects of applying manual pressure and ShotBlocker methods in reducing pain and fear during the subcutaneous insulin injection for children with Type 1 diabetes mellitus. A parallel trial design was used describing two intervention (manual pressure and ShotBlocker) and a control group (no intervention used) as the third arm. The study population consisted of children aged 6-12 years, diagnosed with Type 1 diabetes mellitus, administered insulin injections, able to cognitively score their pain and fear levels, who wanted to participate in the study, and gave verbal and written consent to participate in the study.The study sample composed of 90 children based on confidence interval of 95% and statistical power of 80%. Each intervention and control group was matched in terms of gender. In the study, the randomization of the sample group was performed by using stratification and block randomization methods.

Detailed description: This experimental, prospective, and randomized controlled study was designed to determine and compare the effects of applying manual pressure and ShotBlocker methods in reducing pain and fear during the subcutaneous insulin injection for children with Type 1 diabetes mellitus. A parallel trial design was used describing two intervention (manual pressure and ShotBlocker) and a control group (no intervention used) as the third arm. The study sample composed of 90 children based on confidence interval of 95% and statistical power of 80%. In post-hoc analysis made using G power 3.1 software, the power of sample size including 90 children with α = .05 and effect size (w)= .31, was 1 - β = 0.87. Power of .80 or higher is indicative of an adequate sample size. In addition, in order to prevent bias and increase the validity of the data, the pain and fear scores of the children before and after the procedure were assessed by three different groups as children (n:90), their parents (n:90), and a researcher specialized in pediatric nursing (the first author; n:1), and the inter-observer agreement was examined. The parents meeting the following inclusion criteria were eligible for the participation: 1) being healthy in terms of neurological functions, 2) communicating verbally, 3) understanding and reading Turkish, and 4) voluntarily signing the written informed consent. The children were first categorized according to their genders and then assigned into three study groups by using block randomization method to control the effect of gender on pain. First, the numbers 1, 2 and 3, representing the three groups, were written on paper of the same color and shape and put in a pink box for girls and blue for boys.After, female children were asked to draw a piece of paper from the pink box and male children were asked to draw a piece of paper from the blue box to provide a randomized distribution and to reduce all negative effects. Thus, the groups became self-balanced. Intervention and control groups were matched in themselves based on gender, each group included a total of 30 children including 15 girls and 15 boys. The study was conducted in accordance with the CONSORT guideline for reporting the randomized controlled trials.

Eligibility criteria: Inclusion Criteria:

administered insulin injection, able to score cognitively pain and fear levels, who want to participate in research children who gave verbal and written consent to participate in the study

Exclusion Criteria:Having pacemaker and neurodevelopmental disorder, having lipodystrophy, infection and nerve damage in the injection area, administered analgesics in the last 6 hours, admitted to the outpatient clinic with a picture of ketoacidosis, Diagnosed with Reynaud's syndrome and sickle cell anemia children who do not want to participate in the research

Primary outcomes:
measure: Pain Severity
timeFrame: 5 Months
measure: Fear Severity
timeFrame: 5 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Çankiri
country: Turkey
facility: Çankırı Karatekin Univesity
Study officials:
References: