Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05789810 |
| Other study ID # |
Çankiri Karatekin Üniversitesi |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 10, 2022 |
| Est. completion date |
February 15, 2023 |
Study information
| Verified date |
March 2023 |
| Source |
Çankiri Karatekin University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
