PainNCT05789810
Manual Pressure and ShotBlocker to Reduce Needle-Related Pain and Fear
A study testing Manuel pressure and ShotBlocker in people with Pain and Fear, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- What is being tested?
- Manuel pressure and ShotBlocker
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2022to 15 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Applications Manual Pressure and ShotBlocker to Reduce Needle-Related Pain and Fear in Children With Type 1 Diabetes Mellitus
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.
Read the 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.
- Being tested
- Manuel pressure, ShotBlocker, Control
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manuel pressureOther
10-second manual pressure was applied on the insulin injection area.
ShotBlockerOther
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.
ControlOther
No intervention was performed to reduce pain and fear.
| Study group | Role | What they receive |
|---|---|---|
| Manuel pressure group | Experimental | 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. Receives: Other: Manuel pressure |
| ShotBlocker group | Experimental | 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. Receives: Other: ShotBlocker |
| Control group: | Experimental | No intervention was performed to reduce pain and fear. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity
Wong-Baker FACES Pain Rating Scale was used to assess the pain levels of children before and after the insulin administration. This scale was administered to the children, their parents, and a researcher (the first author) within 5 minutes before and immediately after the insulin administration. The scale was scored blindly before and after the insulin administration so that they were not affected by each other.
Measured: 5 Months
Fear Severity
Child Fear Scale was used to assess pain-related fear levels of children before and after the insulin administration. This scale was administered to the children, their parents, and a researcher (the first author) within 5 minutes before and immediately after the insulin administration. The scale was scored blindly before and after the insulin administration so that they were not affected by each other.
Measured: 5 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start10 Sep 2022
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Saglik Bilimleri University
- Responsible party
- Principal investigator, İLKNUR GÖL, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05789810
- Sponsor's protocol ID
- Çankırı Karatekin Üniversitesi
- Status last verified
- Mar 2023
- First submitted
- 16 Mar 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37651942
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Applications Manual Pressure and ShotBlocker to Reduce Needle-Related Pain and Fear in Children With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05789810
- Acronym / sponsor ID
- Çankırı Karatekin Üniversitesi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Collaborators
- Istanbul Saglik Bilimleri University
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 29 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Interventional
| Arm | Type | Receives |
|---|---|---|
| Manuel pressure group | Experimental | Other: Manuel pressure10-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. |
| ShotBlocker group | Experimental | Other: ShotBlockerShotBlocker 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: | Experimental | Other: ControlNo intervention was performed to reduce pain and fear. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manuel pressure10-second manual pressure was applied on the insulin injection area. | Other | Manuel pressure group |
| ShotBlockerShotBlocker 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. | Other | ShotBlocker group |
| ControlNo intervention was performed to reduce pain and fear. | Other | Control group: |
Primary outcome
Pain Severity
Time frame: 5 Months
Wong-Baker FACES Pain Rating Scale was used to assess the pain levels of children before and after the insulin administration. This scale was administered to the children, their parents, and a researcher (the first author) within 5 minutes before and immediately after the insulin administration. The scale was scored blindly before and after the insulin administration so that they were not affected by each other.
Fear Severity
Time frame: 5 Months
Child Fear Scale was used to assess pain-related fear levels of children before and after the insulin administration. This scale was administered to the children, their parents, and a researcher (the first author) within 5 minutes before and immediately after the insulin administration. The scale was scored blindly before and after the insulin administration so that they were not affected by each other.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Derived from this study: PubMed 37651942Girgin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manuel pressure and ShotBlocker in people with Pain and Fear, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Severity (time frame: 5 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05789810, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.