ChildrenRandomizedNCT07509164
The Effect of a Multimodal Approach on Pain, Fear, and Anxiety in Injection Experiences in Children
A study testing Injection in people with Children and Respiration Disorder, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
Reducing the pain and fear experienced by children during IM injections, one of the painful procedures commonly seen in emergency departments, is an important midwifery/nursing intervention. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Children, Respiration Disorder
- What is being tested?
- Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2025to 30 Jul 2025
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The child must be in the 4-6 age group,
- The IM medication must be ordered by a doctor,
- The IM administration must be performed in the pediatric emergency department,
- The child must not have a disease causing chronic pain,
- The child must not have a neurodevelopmental disorder,
- The child must not have received analgesics in the last 6 hours,
Show all 11Show fewer
- The child must not have a history of fainting during injection,
- The child must not have mental retardation,
- The child must not have scar tissue or muscle atrophy at the injection site,
- The child's percentile must be between 10th and 90th,
- The families and children must agree to participate in the study.
Who cannot join
- -Being younger than 4 years old,
- Being older than 6 years old,
- Having scarring or muscle atrophy at the injection site,
- Having communication problems in the child or parent,
- Having a percentile below 10 (cachectic) or above 90 (obese),
- Families and children not agreeing to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECT OF A MULTIMODAL APPROACH ON PAIN, FEAR, AND ANXIETY IN INJECTION EXPERIENCES
Reducing the pain and fear experienced by children during IM injections, one of the painful procedures commonly seen in emergency departments, is an important midwifery/nursing intervention. The authority of midwives and nurses to use non-pharmacological methods in IM injection administration, which is the most frequent procedure they perform, is expressed in the competency regulations of midwives and nurses. Considering the nature of pediatric emergency units, midwives/nurses increase the comfort of children and even parents by using practical, fast-acting, and low-cost methods that can be easily applied in such painful procedures. To reduce pain and fear during IM injections in children, it is important to both contribute to the literature on the positive effects of non-pharmacological methods in different age groups and to make the use of evidence-based low-cost practices a culture in the units we work in. The aim of the study is to investigate the effects of Buzzy® and HSTT on the pain and fear experienced by children aged 4-6 years during IM injections in pediatric emergency departments.
Read the detailed description
Children in the control group of the study will receive IM injection, which is a routine procedure of the clinic. Children in the intervention group will receive HSTT and Buzzy® application as recommended by the literature. The Questionnaire, Wong Baker Faces Scale, and Child Fear Scale will be used to collect data. The Fear Scale will be administered by the researcher before the IM application, and the Pain and Fear Scales will be administered one minute and five minutes after the procedure. Buzzy® is designed in the shape of a bee and is visually appealing to children. It helps to block the transmission of painful stimuli through vibration. Cold Pack (Ice Wings): It is placed under the device and contacts the application area. Cold reduces the sensation of pain by slowing nerve transmission. The ice pack is frozen in the freezer and placed in the device. Buzzy® is applied to the injection area approximately 1-2 minutes beforehand. The device remains switched on during the procedure.Helfer Skin Tap Technique:
After determining the injection site, gently tap the skin several times with the fingertips of the dominant (most frequently used) hand for approximately 5 seconds to relax the muscle. After wiping and stretching the skin with antiseptic solution, open the cap of the syringe in the dominant (most frequently used) hand. Make a large V shape with the thumb and index finger of the non-dominant hand. Tap the skin three times quickly using the whole hand to stimulate the large muscle fibers. The nurse/midwife counts to 3 and the needle is simultaneously inserted into the muscle at a 90-degree angle. To remove the needle from the skin, tap the skin three times quickly (again in a V shape) with the whole non-dominant hand and withdraw the needle simultaneously with the final tap.
- Conditions
- Children, Respiration Disorder
- Being tested
- Injection
- Keywords
- children, enjection, pain, fear
- Medical subject headings
- Respiration Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InjectionOther
Injetion type
| Study group | Role | What they receive |
|---|---|---|
| intervention group (helper skin tap) | Experimental | helper skin tap Receives: Other: Injection |
| intervention group (Buzzy) | Experimental | Buzzy® Receives: Other: Injection |
| Control group | No intervention | Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Rating Scale
The Wong-Baker FACES Pain Rating Scale was used to assess self-reported pain levels. This scale consists of six facial expressions ranging from "no hurt" (0) to "hurts worst" (10), allowing children to select the face that best represents their level of pain.
Measured: 12 week
Fear Scale
The Children's Fear Scale was used to assess the child's level of fear. This visual scale consists of five facial expressions depicting increasing levels of fear (scores range from 0 to 4). from neutral expression (0=no anxiety) to frightened face (4=severe anxiety)
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start15 Jul 2025
- Primary completion15 Jul 2025
- Study completion30 Jul 2025
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 Sakarya 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, öznur tiryaki, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509164
- Sponsor's protocol ID
- Rabia Yılmaz
- Acronym
- Randomized
- Status last verified
- Mar 2026
- First submitted
- 28 Dec 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethically, patient information can be shared upon reasonable request without revealing their identities for security reasons.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF A MULTIMODAL APPROACH ON PAIN, FEAR, AND ANXIETY IN INJECTION EXPERIENCES
- ClinicalTrials.gov ID
- NCT07509164
- Acronym / sponsor ID
- Randomized / Rabia Yılmaz
- Conditions
- Children, Respiration Disorder
- Keywords
- children, enjection, pain, fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 3 Apr 2026 (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.
Reducing the pain and fear experienced by children during IM injections, one of the painful procedures commonly seen in emergency departments, is an important midwifery/nursing intervention. The authority of midwives and nurses to use non-pharmacological methods in IM injection administration, which is the most frequent procedure they perform, is expressed in the competency regulations of midwives and nurses. Considering the nature of pediatric emergency units, midwives/nurses increase the comfort of children and even parents by using practical, fast-acting, and low-cost methods that can be easily applied in such painful procedures. To reduce pain and fear during IM injections in children, it is important to both contribute to the literature on the positive effects of non-pharmacological methods in different age groups and to make the use of evidence-based low-cost practices a culture in the units we work in. The aim of the study is to investigate the effects of Buzzy® and HSTT on the pain and fear experienced by children aged 4-6 years during IM injections in pediatric emergency departments.
Detailed description
Children in the control group of the study will receive IM injection, which is a routine procedure of the clinic. Children in the intervention group will receive HSTT and Buzzy® application as recommended by the literature. The Questionnaire, Wong Baker Faces Scale, and Child Fear Scale will be used to collect data. The Fear Scale will be administered by the researcher before the IM application, and the Pain and Fear Scales will be administered one minute and five minutes after the procedure. Buzzy® is designed in the shape of a bee and is visually appealing to children. It helps to block the transmission of painful stimuli through vibration. Cold Pack (Ice Wings): It is placed under the device and contacts the application area. Cold reduces the sensation of pain by slowing nerve transmission. The ice pack is frozen in the freezer and placed in the device. Buzzy® is applied to the injection area approximately 1-2 minutes beforehand. The device remains switched on during the procedure.Helfer Skin Tap Technique:
After determining the injection site, gently tap the skin several times with the fingertips of the dominant (most frequently used) hand for approximately 5 seconds to relax the muscle. After wiping and stretching the skin with antiseptic solution, open the cap of the syringe in the dominant (most frequently used) hand. Make a large V shape with the thumb and index finger of the non-dominant hand. Tap the skin three times quickly using the whole hand to stimulate the large muscle fibers. The nurse/midwife counts to 3 and the needle is simultaneously inserted into the muscle at a 90-degree angle. To remove the needle from the skin, tap the skin three times quickly (again in a V shape) with the whole non-dominant hand and withdraw the needle simultaneously with the final tap.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| intervention group (helper skin tap) | Experimental | Other: Injectionhelper skin tap |
| intervention group (Buzzy) | Experimental | Other: InjectionBuzzy® |
| Control group | No intervention | –Control |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- The child must be in the 4-6 age group,
- The IM medication must be ordered by a doctor,
- The IM administration must be performed in the pediatric emergency department,
- The child must not have a disease causing chronic pain,
- The child must not have a neurodevelopmental disorder,
Key exclusion criteria (6 listed)
- -Being younger than 4 years old,
- Being older than 6 years old,
- Having scarring or muscle atrophy at the injection site,
- Having communication problems in the child or parent,
- Having a percentile below 10 (cachectic) or above 90 (obese),
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 |
|---|---|---|
| InjectionInjetion type | Other | intervention group (Buzzy), intervention group (helper skin tap) |
Primary outcome
Pain Rating Scale
Time frame: 12 week
The Wong-Baker FACES Pain Rating Scale was used to assess self-reported pain levels. This scale consists of six facial expressions ranging from "no hurt" (0) to "hurts worst" (10), allowing children to select the face that best represents their level of pain.
Fear Scale
Time frame: 12 week
The Children's Fear Scale was used to assess the child's level of fear. This visual scale consists of five facial expressions depicting increasing levels of fear (scores range from 0 to 4). from neutral expression (0=no anxiety) to frightened face (4=severe anxiety)
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 3 Apr 2026.
- Individual participant dataSharing planned: No. Ethically, patient information can be shared upon reasonable request without revealing their identities for security reasons.
Related trials for Children
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
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 Injection in people with Children and Respiration Disorder, run by Sakarya 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 11 inclusion and 6 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 3 Apr 2026. 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 Rating Scale (time frame: 12 week). 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?
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 3 Apr 2026.