PainNCT06397352
Effects of Buzzy® and ShotBlocker® on Pain, Anxiety and Satisfaction During the Administration of Vaccine
A study testing ShotBlocker® and Buzzy® Group in people with Pain and Anxiety, run by Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to detect and compare the effects of ShotBlocker® and Buzzy® methods on pain, anxiety, and satisfaction during the administration of Tetanus-Diphtheria vaccine to school-aged children. This study was an experimental randomized controlled trial. Read more about this study
- Who is it for?
- Ages 13 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Anxiety, Satisfaction
- What is being tested?
- ShotBlocker® and Buzzy® Group
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 1 Sep 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 13 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 13 years
- being conscious (with the ability to communicate)
Who cannot join
- having a physical and psychological condition
- taking any analgesics, sedatives, or anticonvulsants in the past 24 hours
- having chronic or life-threatening disease
- refusing the shotblocker or buzzy intervention during vaccine injection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Buzzy® and ShotBlocker® on Pain, Anxiety and Satisfaction During the Administration of Tetanus-Diphtheria Vaccine to School-Aged Children: A Randomized Controlled Trial
The aim of this study was to detect and compare the effects of ShotBlocker® and Buzzy® methods on pain, anxiety, and satisfaction during the administration of Tetanus-Diphtheria vaccine to school-aged children. This study was an experimental randomized controlled trial. The sample was included 138 children in a family health centers aged 13 years who underwent Tetanus-Diphtheria vaccine. The participants were randomly assigned to ShotBlocker®, Buzzy®, and control groups. Each group included 46 children, of whom 23 were female and 23 were male. The State-Trait Anxiety Inventory and Visual Analog Scale were used to collect the data.
Read the detailed description
This research aims to determine effects of Buzzy® and ShotBlocker® on pain and anxiety during the administration of tetanus-diphtheria vaccine to school-aged children.
The following hypotheses were determined for the present study. Hypothesis 1. ShotBlocker® is effective in reducing pain and anxiety of children and increasing satisfaction during Tetanus-Diphtheria vaccine injection.
Hypothesis 2. Buzzy® is effective in reducing pain and anxiety of children and increasing satisfaction during Tetanus-Diphtheria vaccine injection.
Hypothesis 3. Buzzy® is more effective than ShotBlocker in reducing pain and anxiety of children and increasing satisfaction during Tetanus-Diphtheria vaccine injection.
This prospective, randomised controlled study was conducted in one family health centers of Manisa, Turkey, between November 2021- August 2023. A parallel trial design was used describing, shotblocker, buzzy, and control group as the third arm. This study was guided by the Consolidated Standards of Reporting Trials (CONSORT) checklist. This study was conducted in one family health centers with the same nurse. Children aged 13 years who underwent tetanus- Diftevaccine injection were eligible to participate in the study. The inclusion criteria were being 13 years and being conscious (with the ability to communicate). The exclusion criteria were having a physical and psychological condition; taking any analgesics, sedatives, or anticonvulsants in the past 24 hours; having chronic or life-threatening disease; and refusing the shotblocker or buzzy intervention during vaccine injection. The sample size for the research was determined using G*power 3.0.8 software, and power analysis was conducted. With a 5% error rate, 80% power, and a medium effect size of 0.25 for the 3 groups with 2 repeated factors, it was calculated that 46 children should be taken for each group (Ellis, 2010). The study sample composed of 138 children. Childrens presenting for tetanus vaccine injection and fulfilling the inclusion criteria were assigned into three groups: Shotblocker®, Buzzy® and control groups (exposed to the conventional injection technique). So that effects of gender could be controlled, the childrens were first categorized according to their genders and then assigned into the three groups through block randomization. To ensure randomization and minimize all possible negative effects, the words shotblocker, buzzy and control, representing the three groups, were written on papers of the same color and shape and placed in a pink and a blue box. During the routine vaccination of children, which group would be included was determined by a lottery drawn by the child, just before the procedure started. The girls were asked to draw a paper from the pink box and boys from the blue box. This allowed keeping the effect of gender under control. Each group included 46 children, of whom 23 were female and 23 were male.
- Conditions
- Pain, Anxiety, Satisfaction
- Being tested
- ShotBlocker®, Buzzy® Group
- Keywords
- Buzzy, Shotblocker, pain, anxiety, satisfaction, vaccine
- Medical subject headings
- Pain, Anxiety Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShotBlocker®Other
All children underwent a standard procedure. The standard procedure involved taking the child into the vaccination room, providing information about the vaccination procedure, introducing the researcher, and obtaining consent. The STAI-S was completed immediately before the vaccination. Children were assigned to groups as specified in the randomization procedure. The vaccination of children was performed by an experienced nurse working in the unit where the study was conducted to control for practitioner-related factors.It is positioned onto the skin before an injection is made. After positioning the ShotBlocker® and ensuring that the contacts were in contact with the children's skin, the injection was made through the central hole by the nurse. The ShotBlocker® was cleaned with 70% alcohol before use on another child.
Buzzy® GroupOther
All children underwent a standard procedure. The standard procedure involved taking the child into the vaccination room, providing information about the vaccination procedure, introducing the researcher, and obtaining consent. The STAI-S was completed immediately before the vaccination. Children were assigned to groups as specified in the randomization procedure. The vaccination of children was performed by an experienced nurse working in the unit where the study was conducted to control for practitioner-related factors. Vibrations started 30 seconds before the procedure and continued until it was completed. The device was cleaned with 70% alcohol before use on another child
| Study group | Role | What they receive |
|---|---|---|
| ShotBlocker® Group | Experimental | The ShotBlocker® is a small, flexible, drug-free plastic device with several short, blunt skin contact points on the bottom and a hole in the center through which injections can be administered. It is positioned onto the skin before an injection is made. After positioning the ShotBlocker® and ensuring that the contacts were in contact with the children's skin, the injection was made through the central hole by the nurse. The ShotBlocker® was cleaned with 70% alcohol before use on another child. Receives: Other: ShotBlocker® |
| Buzzy® Group | Experimental | Buzzy is a small plastic device powered by a vibrating motor and an ice pack. Buzzy is attached to the skin using a tourniquet 3 to 5 cm above the injection site just before the injection. Vibrations started 30 seconds before the procedure and continued until it was completed. The device was cleaned with 70% alcohol before use on another child. Receives: Other: Buzzy® Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
This scale consists of a 10-cm line (0-10 cm or 0-100 mm). The 0-line on the scale indicates "no pain," and the 10-line indicates "unbearable pain." The child is asked to mark the place that expresses the degree of pain. The distance from the point marked by the child to the 0 line is measured to determine the degree of pain. In children aged 8 and above, the Visual Analog Scale (VAS) is considered the most reliable method.
Measured: Visual Analog Scale were completed immediately after the vaccination.
Secondary outcomes (2)
State-Trait Anxiety Inventory (STAI)
The State-Trait Anxiety Inventory (STAI) has been employed in clinical settings to assess levels of both state (STAI-S; i.e., current) and trait (STAI-T; i.e., long-term, general) anxiety. This formwas developed by Spielberger et al. (1971) to measure the anxiety levels of children. The STAI-S was adapted into Turkish by Özusta in 1995, and its validity and reliability study was conducted. The inventory is a 3-point Likert-type scale consisting of 20 items that aim to evaluate feelings associated with state anxiety. The children evaluated how they felt 'at that moment' as "almost never" (1 point), "sometimes" (2 points), and "often" (3 points). The scale ranges from 20 to 60 points, with a high score indicating a high level of anxiety.
Measured: State-Trait Anxiety Inventory (STAI) were completed immediately after the vaccination
Satisfaction level
children were asked to rate their satisfaction level with the vaccination on a scale of 0 points "not satisfied" to 10 points "very satisfied"
Measured: Satisfaction were completed immediately after the vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start1 Nov 2021
- Primary completion1 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants were randomly assigned to ShotBlocker®, Buzzy®, and control groups.
- Masking
- None (open label)
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice ERDEM ÖNDER, Mehmet Akif Ersoy University
- Investigators
- Hatice Erdem Önder, Study chair, Mehmet Akif Ersoy UniversityDilek Sari, Study director, Ege UniversityNihal Taşkiran, Study chair, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397352
- Sponsor's protocol ID
- MehmetAkifU-SBF-HEÖ-02
- Status last verified
- Apr 2024
- First submitted
- 25 Apr 2024
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- 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 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Buzzy® and ShotBlocker® on Pain, Anxiety and Satisfaction During the Administration of Tetanus-Diphtheria Vaccine to School-Aged Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06397352
- Acronym / sponsor ID
- MehmetAkifU-SBF-HEÖ-02
- Conditions
- Pain, Anxiety, Satisfaction
- Keywords
- Buzzy, Shotblocker, pain, anxiety, satisfaction, vaccine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 2 May 2024 (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 this study was to detect and compare the effects of ShotBlocker® and Buzzy® methods on pain, anxiety, and satisfaction during the administration of Tetanus-Diphtheria vaccine to school-aged children. This study was an experimental randomized controlled trial. The sample was included 138 children in a family health centers aged 13 years who underwent Tetanus-Diphtheria vaccine. The participants were randomly assigned to ShotBlocker®, Buzzy®, and control groups. Each group included 46 children, of whom 23 were female and 23 were male. The State-Trait Anxiety Inventory and Visual Analog Scale were used to collect the data.
Detailed description
This research aims to determine effects of Buzzy® and ShotBlocker® on pain and anxiety during the administration of tetanus-diphtheria vaccine to school-aged children.
The following hypotheses were determined for the present study. Hypothesis 1. ShotBlocker® is effective in reducing pain and anxiety of children and increasing satisfaction during Tetanus-Diphtheria vaccine injection.
Hypothesis 2. Buzzy® is effective in reducing pain and anxiety of children and increasing satisfaction during Tetanus-Diphtheria vaccine injection.
Hypothesis 3. Buzzy® is more effective than ShotBlocker in reducing pain and anxiety of children and increasing satisfaction during Tetanus-Diphtheria vaccine injection.
This prospective, randomised controlled study was conducted in one family health centers of Manisa, Turkey, between November 2021- August 2023. A parallel trial design was used describing, shotblocker, buzzy, and control group as the third arm. This study was guided by the Consolidated Standards of Reporting Trials (CONSORT) checklist. This study was conducted in one family health centers with the same nurse. Children aged 13 years who underwent tetanus- Diftevaccine injection were eligible to participate in the study. The inclusion criteria were being 13 years and being conscious (with the ability to communicate). The exclusion criteria were having a physical and psychological condition; taking any analgesics, sedatives, or anticonvulsants in the past 24 hours; having chronic or life-threatening disease; and refusing the shotblocker or buzzy intervention during vaccine injection. The sample size for the research was determined using G*power 3.0.8 software, and power analysis was conducted. With a 5% error rate, 80% power, and a medium effect size of 0.25 for the 3 groups with 2 repeated factors, it was calculated that 46 children should be taken for each group (Ellis, 2010). The study sample composed of 138 children. Childrens presenting for tetanus vaccine injection and fulfilling the inclusion criteria were assigned into three groups: Shotblocker®, Buzzy® and control groups (exposed to the conventional injection technique). So that effects of gender could be controlled, the childrens were first categorized according to their genders and then assigned into the three groups through block randomization. To ensure randomization and minimize all possible negative effects, the words shotblocker, buzzy and control, representing the three groups, were written on papers of the same color and shape and placed in a pink and a blue box. During the routine vaccination of children, which group would be included was determined by a lottery drawn by the child, just before the procedure started. The girls were asked to draw a paper from the pink box and boys from the blue box. This allowed keeping the effect of gender under control. Each group included 46 children, of whom 23 were female and 23 were male.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants were randomly assigned to ShotBlocker®, Buzzy®, and control groups.
| Arm | Type | Receives |
|---|---|---|
| ShotBlocker® Group | Experimental | Other: ShotBlocker®The ShotBlocker® is a small, flexible, drug-free plastic device with several short, blunt skin contact points on the bottom and a hole in the center through which injections can be administered. It is positioned onto the skin before an injection is made. After positioning the ShotBlocker® and ensuring that the contacts were in contact with the children's skin, the injection was made through the central hole by the nurse. The ShotBlocker® was cleaned with 70% alcohol before use on another child. |
| Buzzy® Group | Experimental | Other: Buzzy® GroupBuzzy is a small plastic device powered by a vibrating motor and an ice pack. Buzzy is attached to the skin using a tourniquet 3 to 5 cm above the injection site just before the injection. Vibrations started 30 seconds before the procedure and continued until it was completed. The device was cleaned with 70% alcohol before use on another child. |
Who may qualify
- Ages
- 13 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 13 years
- being conscious (with the ability to communicate)
Key exclusion criteria (4 listed)
- having a physical and psychological condition
- taking any analgesics, sedatives, or anticonvulsants in the past 24 hours
- having chronic or life-threatening disease
- refusing the shotblocker or buzzy intervention during vaccine injection.
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 |
|---|---|---|
| ShotBlocker®All children underwent a standard procedure. The standard procedure involved taking the child into the vaccination room, providing information about the vaccination procedure, introducing the researcher, and obtaining consent. The STAI-S was completed immediately before the vaccination. Children were assigned to groups as specified in the randomization procedure. The vaccination of children was performed by an experienced nurse working in the unit where the study was conducted to control for practitioner-related factors.It is positioned onto the skin before an injection is made. After positioning the ShotBlocker® and ensuring that the contacts were in contact with the children's skin, the injection was made through the central hole by the nurse. The ShotBlocker® was cleaned with 70% alcohol before use on another child. | Other | ShotBlocker® Group |
| Buzzy® GroupAll children underwent a standard procedure. The standard procedure involved taking the child into the vaccination room, providing information about the vaccination procedure, introducing the researcher, and obtaining consent. The STAI-S was completed immediately before the vaccination. Children were assigned to groups as specified in the randomization procedure. The vaccination of children was performed by an experienced nurse working in the unit where the study was conducted to control for practitioner-related factors. Vibrations started 30 seconds before the procedure and continued until it was completed. The device was cleaned with 70% alcohol before use on another child | Other | Buzzy® Group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Visual Analog Scale were completed immediately after the vaccination.
This scale consists of a 10-cm line (0-10 cm or 0-100 mm). The 0-line on the scale indicates "no pain," and the 10-line indicates "unbearable pain." The child is asked to mark the place that expresses the degree of pain. The distance from the point marked by the child to the 0 line is measured to determine the degree of pain. In children aged 8 and above, the Visual Analog Scale (VAS) is considered the most reliable method.
2 secondary outcomes
State-Trait Anxiety Inventory (STAI)
Time frame: State-Trait Anxiety Inventory (STAI) were completed immediately after the vaccination
Satisfaction level
Time frame: Satisfaction were completed immediately after the vaccination
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 2 May 2024.
- 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.
Hatice Erdem Önder study chair
Mehmet Akif Ersoy University
Dilek Sari study director
Ege University
Nihal Taşkiran study chair
Aydin Adnan Menderes 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® and Buzzy® Group in people with Pain and Anxiety, run by Mehmet Akif Ersoy 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 4 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 2 May 2024. 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?
Visual Analog Scale (VAS) (time frame: Visual Analog Scale were completed immediately after the vaccination.). 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 2 May 2024.