Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05789810
Status:
COMPLETED
Last Update Posted:
2023-03-29
First Post:
2023-03-16
Brief Title:
Manual Pressure and ShotBlocker to Reduce Needle-Related Pain and Fear
Sponsor:
Çankırı Karatekin University
Organization:
Çankırı Karatekin University
Study Overview
Official Title:
Effects of Applications Manual Pressure and ShotBlocker to Reduce Needle-Related Pain and Fear in Children With Type 1 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 studyThe 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 31 software the power of sample size including 90 children with α 05 and effect size w 31 was 1 - β 087 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 n90 their parents n90 and a researcher specialized in pediatric nursing the first author n1 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 boysAfter 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None