ChildrenNCT05725551
The Effect of Shotblocker, Finger Puppet And Balloon Method During Intramuscular Injection
A study testing ShotBlocker, Finger Puppet group and Balloon group in people with Children, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the randomized controlled study is to examine the effects of ShotBlocker, finger puppet and balloon inflation methods applied during intramuscular injection procedure on children's pain and fear level. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Children
- What is being tested?
- ShotBlocker, Finger Puppet group and Balloon group
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 31 Dec 2022
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who volunteered to participate in the study and who met the inclusion criteria
Who cannot join
- Children who did not volunteer to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three Applıed Durıng Intramuscular Injectıon In Chıldren Effect Of Dıfferent Method On Paın And Fear
The aim of the randomized controlled study is to examine the effects of ShotBlocker, finger puppet and balloon inflation methods applied during intramuscular injection procedure on children's pain and fear level.
Read the detailed description
The aim of the randomized controlled study is to examine the effects of ShotBlocker, finger puppet and balloon inflation methods applied during intramuscular injection procedure on 7-12 age group children on pain and fear level.
The purpose of the research and all the working processes were explained to the children and parents by the researcher.
Children who met all eligibility criteria were invited to participate in the study with their parents.
The children and their parents were informed about the study, they were included in the study by announcing that they would be in one of the four groups, and this group was randomly determined.
Before starting the application, verbal and written consent was obtained from the parents of the children by reading/reading the Informed Voluntary Consent Form.
The child and parent were informed by the researcher about the pain and fear level assessment tools and application before and after the procedure.
- Conditions
- Children
- Being tested
- ShotBlocker, Finger Puppet group, Balloon group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShotBlockerDevice
Before the procedure, the protruding surface of the vehicle was placed on the injection site in contact with the skin and used by holding it during injection. The level of pain and fear experienced by the child during and 5 minutes after the injection was evaluated with the "Facial Expressions Pain Scale" and "Visual Comparison Scale", and the level of fear was evaluated with the "Child Fear Scale" by the child, the parent accompanying the child, and the observer.
Finger Puppet groupOther
During the interaction between the finger puppet and the child, an intramuscular injection was made. The level of pain experienced by the child during the injection and 5 minutes after the injection was evaluated by the child, the parent and the observer through the "Facial Expressions Pain Scale" and the "Visual Comparison Scale", and the fear level by the "Child Fear Scale".
Balloon groupOther
An intramuscular injection was given when the child began to inflate the balloon. The level of pain experienced by the child during the injection and 5 minutes after the injection was evaluated by the child, the parent and the observer through the "Facial Expressions Pain Scale" and the "Visual Comparison Scale", and the fear level by the "Child Fear Scale".
| Study group | Role | What they receive |
|---|---|---|
| ShotBlocker group | Experimental | Pain in intramuscular injection It is a noninvasive, plastic tool used to reduce. Receives: Device: ShotBlocker |
| Finger Puppet group | Experimental | Finger puppetry is an alternative method of interacting with the child through play while performing an intramuscular injection. Receives: Other: Finger Puppet group |
| Balloon group | Experimental | Balloon inflation method, the child inflating the balloon while performing an intramuscular injection. Receives: Other: Balloon group |
| Control Group | No intervention | Intramuscular injection without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Fear Scale
The scale is a visual measurement tool consisting of five drawn facial expressions ranging from neutral expression (0=no anxiety) to frightened face (4=severe anxiety) and scores between 0-4 points.The level of pain experienced by the children in all groups during the injection and 5 minutes after the injection was evaluated.
Measured: 1 day
Facial Pain Scale
Graded according to the severity of the pain, the leftmost face consists of "no pain" and the rightmost face consists of a total of 6 facial expressions, such as "too much pain". Faces expressing the increase in pain intensity from left to right are scored as 0,2,4,6,8,10, respectively.The level of fear experienced by the children in all groups during the injection and 5 minutes after the injection was evaluated.
Measured: 1 day
Visual Analog Scale
The scale consists of a 10 cm / 100 mm long ruler that can be used horizontally or vertically, with "no pain" at one end and "worst pain imaginable" at the other. The child is asked to mark a spot on the line that will accurately reflect his or her pain.The level of pain experienced by the children in all groups during the injection and 5 minutes after the injection was evaluated.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Oct 2022
- Primary completion1 Oct 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didem Lafci, Mersin University
- Investigators
- Diğdem Lafcı pHD, Principal investigator, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725551
- Sponsor's protocol ID
- MU
- Status last verified
- Feb 2023
- First submitted
- 12 Jan 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Applıed Durıng Intramuscular Injectıon In Chıldren Effect Of Dıfferent Method On Paın And Fear
- ClinicalTrials.gov ID
- NCT05725551
- Acronym / sponsor ID
- MU
- Conditions
- Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 13 Feb 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.
The aim of the randomized controlled study is to examine the effects of ShotBlocker, finger puppet and balloon inflation methods applied during intramuscular injection procedure on children's pain and fear level.
Detailed description
The aim of the randomized controlled study is to examine the effects of ShotBlocker, finger puppet and balloon inflation methods applied during intramuscular injection procedure on 7-12 age group children on pain and fear level.
The purpose of the research and all the working processes were explained to the children and parents by the researcher.
Children who met all eligibility criteria were invited to participate in the study with their parents.
The children and their parents were informed about the study, they were included in the study by announcing that they would be in one of the four groups, and this group was randomly determined.
Before starting the application, verbal and written consent was obtained from the parents of the children by reading/reading the Informed Voluntary Consent Form.
The child and parent were informed by the researcher about the pain and fear level assessment tools and application before and after the procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ShotBlocker group | Experimental | Device: ShotBlockerPain in intramuscular injection It is a noninvasive, plastic tool used to reduce. |
| Finger Puppet group | Experimental | Other: Finger Puppet groupFinger puppetry is an alternative method of interacting with the child through play while performing an intramuscular injection. |
| Balloon group | Experimental | Other: Balloon groupBalloon inflation method, the child inflating the balloon while performing an intramuscular injection. |
| Control Group | No intervention | –Intramuscular injection without any intervention. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children who volunteered to participate in the study and who met the inclusion criteria
Key exclusion criteria (1 listed)
- Children who did not volunteer to participate in the study
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 |
|---|---|---|
| ShotBlockerBefore the procedure, the protruding surface of the vehicle was placed on the injection site in contact with the skin and used by holding it during injection. The level of pain and fear experienced by the child during and 5 minutes after the injection was evaluated with the "Facial Expressions Pain Scale" and "Visual Comparison Scale", and the level of fear was evaluated with the "Child Fear Scale" by the child, the parent accompanying the child, and the observer. | Device | ShotBlocker group |
| Finger Puppet groupDuring the interaction between the finger puppet and the child, an intramuscular injection was made. The level of pain experienced by the child during the injection and 5 minutes after the injection was evaluated by the child, the parent and the observer through the "Facial Expressions Pain Scale" and the "Visual Comparison Scale", and the fear level by the "Child Fear Scale". | Other | Finger Puppet group |
| Balloon groupAn intramuscular injection was given when the child began to inflate the balloon. The level of pain experienced by the child during the injection and 5 minutes after the injection was evaluated by the child, the parent and the observer through the "Facial Expressions Pain Scale" and the "Visual Comparison Scale", and the fear level by the "Child Fear Scale". | Other | Balloon group |
Primary outcome
Child Fear Scale
Time frame: 1 day
The scale is a visual measurement tool consisting of five drawn facial expressions ranging from neutral expression (0=no anxiety) to frightened face (4=severe anxiety) and scores between 0-4 points.The level of pain experienced by the children in all groups during the injection and 5 minutes after the injection was evaluated.
Facial Pain Scale
Time frame: 1 day
Graded according to the severity of the pain, the leftmost face consists of "no pain" and the rightmost face consists of a total of 6 facial expressions, such as "too much pain". Faces expressing the increase in pain intensity from left to right are scored as 0,2,4,6,8,10, respectively.The level of fear experienced by the children in all groups during the injection and 5 minutes after the injection was evaluated.
Visual Analog Scale
Time frame: 1 day
The scale consists of a 10 cm / 100 mm long ruler that can be used horizontally or vertically, with "no pain" at one end and "worst pain imaginable" at the other. The child is asked to mark a spot on the line that will accurately reflect his or her pain.The level of pain experienced by the children in all groups during the injection and 5 minutes after the injection was evaluated.
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 13 Feb 2023.
- 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.
Diğdem Lafcı pHD principal investigator
Mersin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ShotBlocker, Finger Puppet group and Balloon group in people with Children, run by Mersin 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 1 inclusion and 1 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 13 Feb 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?
Child Fear Scale (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Feb 2023.