PainNCT04847934
Effect Of Distraction Methods On Procedure-Related Fear, Anxiety, And Pain During Intramuscular Injection
A study testing distraction methods in people with Pain and Fear, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
Buzzy, shot-blocker, distraction cards, and balloon blowing can reduce fear and pain during the intramuscular intervention in the pediatric emergency service unit. This study aimed to evaluate the effect of virtual reality, manual pressure vibration technique, and cold vibration device application on procedure-related… Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- What is being tested?
- distraction methods
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2021to 30 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children are between the ages of 5-12
- Intramuscular antibiotics (penicillin, ceftriaxone, amikacin etc.) to be administered
- The intervention will be applied from the gluteal region
- The child agrees to voluntarily participate in the study.
- Parents agree to voluntarily participate in the study
- Obtaining consent form from the child and parent
Who cannot join
- child with a physical and psychological deficit to prevent him from wearing the glasses to be worn on his head so that he can watch virtual reality.
- child with sedative or analgesic medication.
- child with a neurodegenerative disease, mental retardation, vision and hearing problems, chronic, life-threatening (sepsis, shock, respiratory / cardiac arrest) or genetic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Distraction Methods On Procedure-Related Fear, Anxiety, And Pain During Intramuscular Injection in Pediatric Emergency Department
Buzzy, shot-blocker, distraction cards, and balloon blowing can reduce fear and pain during the intramuscular intervention in the pediatric emergency service unit. This study aimed to evaluate the effect of virtual reality, manual pressure vibration technique, and cold vibration device application on procedure-related pain, fear, and anxiety during intramuscular antibiotics in children aged 5-12 years in the pediatric emergency department.
Read the detailed description
Study Hypothesis The pain, fear, and anxiety scores of the children who watch videos with virtual reality glasses during the intramuscular intervention are lower than the other groups.
The pain, fear, and anxiety scores of children who were applied manual pressure vibration technique during the intramuscular intervention are lower than the other groups.
The pain, fear, and anxiety scores of the children who were applied cold vibration (Buzzy) during the intramuscular intervention were lower than the other groups.
The emotional appearance scores of the children in groups before the procedure affect the pain, fear, and anxiety they experience.
The group with children affects the vital signs before and after the distraction technique.
Methods Study Design and Sample It was planned to include children between the ages of 5-12 who will be administered intramuscular antibiotics in the Dokuz Eylül University Pediatric Emergency Service. It is planned to include patients selected by the stratified randomization method in accordance with the sampling criteria.
Randomization Children will allocate by the stratified randomization; gender, age, and antibiotics type. Randomization was performed with a computerized random-number generator.
Socio-Demographic Data Collection and Procedure Follow-up Form: It includes "age, gender, the reason for admitting to the emergency unit, the last painful intervention and date, the name of the antibiotic administered, and the accompanying parent". At the same time, the duration and vital signs of the interventions applied to the child will be recorded.
Wong-Baker FACES (WBS) Pain Rating Scale. This scale uses in children aged 3 and older to rate pain severity, ranges from 0 (very happy/no pain) to 10 (hurts worst).
The Child Fear Scale (CFS). The Child Fear Scale will use.This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear. This rating scale ranges from 0 to 4. It ranges from a no fear (neutral) face (0) on the far left to a face showing extreme fear on the far right. Higher scores mean a worse outcome. The rater response indicates the level of fear. It can be used during the procedure for children aged 5-10 years.
The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety.
Emotional Appearance Scale for Children: This scale allows direct behavioral observation, consists of 5 different behavioral categories; 'Facial Expression', 'Speaking', 'Activity', 'Interaction' and 'Cooperation Level'.
Scale scoring is done by reviewing the descriptions of behavior in each category and selecting the numerical value that most represents the observed behavior. Each category is scored from 1 to 5. The total score is made so that the numerical value is between 5-25 by adding the points obtained for each category. Higher scale score indicates the appearance of more negative emotional behaviors.
Data collection process Each patient included in the study will be taken to the bed where the intervention will be made and monitored, pulse, respiration, and blood pressure will be measured. The child will be evaluated by the nurse before the procedure with the Emotional Appearance Scale for Children (0. Min).
In the virtual glasses group, the video will be started by wearing virtual glasses.
The manual pressure vibration technique will be applied for 15 seconds. In the cold vibration group, Arı Buzzy will be connected 5 cm above the IM intervention area and applied for 15 seconds.
The hour/minute applied by the IM intervention will be recorded. When he enters the vascular access, he will give information to the child by saying "now it will be over, I am pressing it with cotton". The patient's pulse, respiration, blood pressure will be measured again (minutes will be recorded). Pulse, respiration, and blood pressure will be re-evaluated at the 5th minute of the beginning of the procedure. At the 5th minute of the procedure, the child will be asked to evaluate the most painful moment he feels during the procedure with the Facial Expressions Rating Scale. The child will be given the Child Fear Scale (CAS) and the Child Anxiety Scale-Statefulness (CAS-D) to evaluate how anxious and afraid he or she is during the procedure. You will be asked to mark it with a pencil.
Ethics Ethical approval was received from the Non-Invasive Clinical Studies Ethics Committee of the University where the research was conducted (5856GOA 2021). The researcher informed about the aim of the study and obtained written consent forms from children and parents.
- Conditions
- Pain, Fear, Anxiety, Child, Only
- Being tested
- distraction methods
- Keywords
- intramuscular injection, distraction methods, cold vibration, manuel pressure vibration, virtual reality
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
distraction methodsBehavioural
distraction methods
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | watching the application by wearing virtual glasses to the child during the intramuscular injection Receives: Behavioral: distraction methods |
| Manual Pressure Vibration Technique Group | Experimental | Application of manual pressure vibration technique to the area where the intervention will be made Receives: Behavioral: distraction methods |
| Cold Vibration Group | Experimental | Buzzy, connecting and operating 5 cm above the area to be injected Receives: Behavioral: distraction methods |
| Control Group | No intervention | Standart care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assesed by Wong-Baker FACES
Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst).
Measured: procedure (during the ıntramuscular injection)
Anxiety assesed by Children Anxiety Meter-State
The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety
Measured: procedure (during the intramuscular injection)
Fear assesed by Child Fear Scale
The Child Fear Scale (CFS). The Child Fear Scale will use.This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear. This rating scale ranges from 0 to 4. It ranges from a no fear (neutral) face (0) on the far left to a face showing extreme fear on the far right. Higher scores mean a worse outcome. The rater responds indicates the level of fear. It can be used during the procedure for children aged 5-10 years.
Measured: procedure (during the ıntramuscular injection)
Secondary outcomes (1)
Emotional Appearance Scale for Children
This scale allows direct behavioral observation, consists of 5 different behavioral categories; 'Facial Expression', 'Speaking', 'Activity', 'Interaction' and 'Cooperation Level'.
Scale scoring is done by reviewing the descriptions of behavior in each category and selecting the numerical value that most represents the observed behavior. Each category is scored from 1 to 5. The total score is made so that the numerical value is between 5-25 by adding the points obtained for each category. Higher scale score indicates the appearance of more negative emotional behaviors.
Measured: Baseline (before the intramuscular injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start30 Jan 2021
- Primary completion29 Dec 2022
- Study completion30 Dec 2022
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülçin Özalp Gerçeker, Dokuz Eylul University
- Investigators
- Gülçin Ö Gerçeker, Study director, RN, PhD, Assoc. Prof.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847934
- Sponsor's protocol ID
- 5856-GOA
- Status last verified
- Jul 2022
- First submitted
- 7 Apr 2021
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gulduran E, Ozalp Gerceker G. Effect of Distracting Methods on Procedure-Related Fear, Anxiety, and Pain During Intramuscular Injection: A Randomized Controlled Trial. J Emerg Nurs. 2026 Jan;52(1):127-142. doi: 10.1016/j.jen.2025.08.003. Epub 2025 Sep 9.
PubMed 40923961
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Distraction Methods On Procedure-Related Fear, Anxiety, And Pain During Intramuscular Injection in Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT04847934
- Acronym / sponsor ID
- 5856-GOA
- Conditions
- Pain, Fear, Anxiety, Child, Only
- Keywords
- intramuscular injection, distraction methods, cold vibration, manuel pressure vibration, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 30 Jan 2021 (actual)
- Primary completion
- 29 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 19 Apr 2021 (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.
Buzzy, shot-blocker, distraction cards, and balloon blowing can reduce fear and pain during the intramuscular intervention in the pediatric emergency service unit. This study aimed to evaluate the effect of virtual reality, manual pressure vibration technique, and cold vibration device application on procedure-related pain, fear, and anxiety during intramuscular antibiotics in children aged 5-12 years in the pediatric emergency department.
Detailed description
Study Hypothesis The pain, fear, and anxiety scores of the children who watch videos with virtual reality glasses during the intramuscular intervention are lower than the other groups.
The pain, fear, and anxiety scores of children who were applied manual pressure vibration technique during the intramuscular intervention are lower than the other groups.
The pain, fear, and anxiety scores of the children who were applied cold vibration (Buzzy) during the intramuscular intervention were lower than the other groups.
The emotional appearance scores of the children in groups before the procedure affect the pain, fear, and anxiety they experience.
The group with children affects the vital signs before and after the distraction technique.
Methods Study Design and Sample It was planned to include children between the ages of 5-12 who will be administered intramuscular antibiotics in the Dokuz Eylül University Pediatric Emergency Service. It is planned to include patients selected by the stratified randomization method in accordance with the sampling criteria.
Randomization Children will allocate by the stratified randomization; gender, age, and antibiotics type. Randomization was performed with a computerized random-number generator.
Socio-Demographic Data Collection and Procedure Follow-up Form: It includes "age, gender, the reason for admitting to the emergency unit, the last painful intervention and date, the name of the antibiotic administered, and the accompanying parent". At the same time, the duration and vital signs of the interventions applied to the child will be recorded.
Wong-Baker FACES (WBS) Pain Rating Scale. This scale uses in children aged 3 and older to rate pain severity, ranges from 0 (very happy/no pain) to 10 (hurts worst).
The Child Fear Scale (CFS). The Child Fear Scale will use.This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear. This rating scale ranges from 0 to 4. It ranges from a no fear (neutral) face (0) on the far left to a face showing extreme fear on the far right. Higher scores mean a worse outcome. The rater response indicates the level of fear. It can be used during the procedure for children aged 5-10 years.
The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety.
Emotional Appearance Scale for Children: This scale allows direct behavioral observation, consists of 5 different behavioral categories; 'Facial Expression', 'Speaking', 'Activity', 'Interaction' and 'Cooperation Level'.
Scale scoring is done by reviewing the descriptions of behavior in each category and selecting the numerical value that most represents the observed behavior. Each category is scored from 1 to 5. The total score is made so that the numerical value is between 5-25 by adding the points obtained for each category. Higher scale score indicates the appearance of more negative emotional behaviors.
Data collection process Each patient included in the study will be taken to the bed where the intervention will be made and monitored, pulse, respiration, and blood pressure will be measured. The child will be evaluated by the nurse before the procedure with the Emotional Appearance Scale for Children (0. Min).
In the virtual glasses group, the video will be started by wearing virtual glasses.
The manual pressure vibration technique will be applied for 15 seconds. In the cold vibration group, Arı Buzzy will be connected 5 cm above the IM intervention area and applied for 15 seconds.
The hour/minute applied by the IM intervention will be recorded. When he enters the vascular access, he will give information to the child by saying "now it will be over, I am pressing it with cotton". The patient's pulse, respiration, blood pressure will be measured again (minutes will be recorded). Pulse, respiration, and blood pressure will be re-evaluated at the 5th minute of the beginning of the procedure. At the 5th minute of the procedure, the child will be asked to evaluate the most painful moment he feels during the procedure with the Facial Expressions Rating Scale. The child will be given the Child Fear Scale (CAS) and the Child Anxiety Scale-Statefulness (CAS-D) to evaluate how anxious and afraid he or she is during the procedure. You will be asked to mark it with a pencil.
Ethics Ethical approval was received from the Non-Invasive Clinical Studies Ethics Committee of the University where the research was conducted (5856GOA 2021). The researcher informed about the aim of the study and obtained written consent forms from children and parents.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Behavioral: distraction methodswatching the application by wearing virtual glasses to the child during the intramuscular injection |
| Manual Pressure Vibration Technique Group | Experimental | Behavioral: distraction methodsApplication of manual pressure vibration technique to the area where the intervention will be made |
| Cold Vibration Group | Experimental | Behavioral: distraction methodsBuzzy, connecting and operating 5 cm above the area to be injected |
| Control Group | No intervention | –Standart care |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children are between the ages of 5-12
- Intramuscular antibiotics (penicillin, ceftriaxone, amikacin etc.) to be administered
- The intervention will be applied from the gluteal region
- The child agrees to voluntarily participate in the study.
- Parents agree to voluntarily participate in the study
Key exclusion criteria (3 listed)
- child with a physical and psychological deficit to prevent him from wearing the glasses to be worn on his head so that he can watch virtual reality.
- child with sedative or analgesic medication.
- child with a neurodegenerative disease, mental retardation, vision and hearing problems, chronic, life-threatening (sepsis, shock, respiratory / cardiac arrest) or genetic disease
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 |
|---|---|---|
| distraction methodsdistraction methods | Behavioural | Cold Vibration Group, Manual Pressure Vibration Technique Group, Virtual Reality Group |
Primary outcome
Pain assesed by Wong-Baker FACES
Time frame: procedure (during the ıntramuscular injection)
Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst).
Anxiety assesed by Children Anxiety Meter-State
Time frame: procedure (during the intramuscular injection)
The Children's Anxiety Meter (CAM-S). The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). This scale ranges from 0 to 10. Higher values represent higher anxiety
Fear assesed by Child Fear Scale
Time frame: procedure (during the ıntramuscular injection)
The Child Fear Scale (CFS). The Child Fear Scale will use.This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges from 0 (no fear) to extreme fear. This rating scale ranges from 0 to 4. It ranges from a no fear (neutral) face (0) on the far left to a face showing extreme fear on the far right. Higher scores mean a worse outcome. The rater responds indicates the level of fear. It can be used during the procedure for children aged 5-10 years.
1 secondary outcome
Emotional Appearance Scale for Children
Time frame: Baseline (before the intramuscular injection)
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 8 Mar 2023.
- Derived from this study: PubMed 40923961Gulduran E, Ozalp Gerceker G. Effect of Distracting Methods on Procedure-Related Fear, Anxiety, and Pain During Intramuscular Injection: A Randomized Controlled Trial. J Emerg Nurs. 2026 Jan;52(1):127-142. doi: 10.1016/j.jen.2025.08.003. Epub 2025 Sep 9.
- 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.
Gülçin Ö Gerçeker study director
RN, PhD, Assoc. Prof.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing distraction methods in people with Pain and Fear, run by Dokuz Eylul 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 6 inclusion and 3 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 8 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 assesed by Wong-Baker FACES (time frame: procedure (during the ıntramuscular injection)). 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?
On the ClinicalTrials.gov record for NCT04847934, 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 8 Mar 2023.