Manual Pressure and ShotBlocker to Reduce Needle-Related Pain and Fear

NCT ID: NCT05789810

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-10
• Study Completion Date: 2023-02-15

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.

Conditions

Pain; Fear

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Manuel pressure group

10-second manual pressure was applied on the insulin injection area. The injection point was pressed by the diabetes nurse's right thumb over the site until resistance was felt and the pressure was then maintained for 10 seconds before the insulin injection. Then insulin injection was administered.

Group Type: EXPERIMENTAL

Manuel pressure

Intervention Type: OTHER

10-second manual pressure was applied on the insulin injection area.

ShotBlocker group

ShotBlocker device was placed in the insulin injection site by contacting the protruding surface with the skin and was kept throughout the injection. The injection was applied through the opening at the middle of the tool.

Group Type: EXPERIMENTAL

ShotBlocker

Intervention Type: OTHER

ShotBlocker device was placed in the insulin injection site by contacting the protruding surface with the skin and was kept throughout the injection. The injection was applied through the opening at the middle of the tool.

Control group:

No intervention was performed to reduce pain and fear.

Group Type: EXPERIMENTAL

Control

Intervention Type: OTHER

No intervention was performed to reduce pain and fear.

Interventions

Manuel pressure

10-second manual pressure was applied on the insulin injection area.

Intervention Type: OTHER

ShotBlocker

ShotBlocker device was placed in the insulin injection site by contacting the protruding surface with the skin and was kept throughout the injection. The injection was applied through the opening at the middle of the tool.

Intervention Type: OTHER

Control

No intervention was performed to reduce pain and fear.

Intervention Type: OTHER

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul Saglik Bilimleri University

OTHER

Sponsor Role: collaborator

Çankırı Karatekin University

OTHER

Sponsor Role: lead

Responsible Party

İLKNUR GÖL

Assoc. Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Çankırı Karatekin Univesity

Çankiri, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Girgin BA, Gol I, Gozen D, Carikci F, Kirmizibekmez H. Effects of applications manual pressure and shotblocker to reduce needle-related pain and fear in children with type 1 diabetes mellitus. J Pediatr Nurs. 2023 Nov-Dec;73:84-90. doi: 10.1016/j.pedn.2023.08.024. Epub 2023 Aug 30.

Reference Type: DERIVED

PMID: 37651942 (View on PubMed)

Other Identifiers

Çankırı Karatekin Üniversitesi

Identifier Type: -

Identifier Source: org_study_id