VaccineNCT05752747
The Effect of Shotblocker and Cold Massage on Pain, Crying Time and Physiological Parameters in Babies
A study testing Cold Massage Group and ShotBlocker© Group in people with Vaccine and Pain, run by Ordu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to determine the effect of ShotBlocker© and cold massage on pain, crying time and physiological parameters during DaBT-IPA-Hib vaccine administration in 2-6 months old babies. Read more about this study
- Who is it for?
- Ages 2 to 6 monthsHealthy volunteers can take part
- What is being tested?
- Cold Massage Group and ShotBlocker© Group
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Nov 2022to 30 Jun 2024
- 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 2 to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The baby is 2-6 months old,
- DaBT- IPA- Hib vaccine will be administered,
- The baby does not have a chronic disease,
- Parents must be at least primary school graduate,
- Parent's willingness to participate in the study.
Who cannot join
- Having a congenital or neurological health problem,
- Have taken an analgesic drug in the last 4 hours,
- Babies with a body temperature above 37.5 will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Shotblocker and Cold Massage on Pain, Crying Time and Physiological Parameters During Vaccine Injection in Babies
The aim of this study is to determine the effect of ShotBlocker© and cold massage on pain, crying time and physiological parameters during DaBT-IPA-Hib vaccine administration in 2-6 months old babies.
Read the detailed description
The aim of this study is to determine the effect of ShotBlocker© and cold massage on pain, crying time and physiological parameters during DaBT-IPA-Hib vaccine administration in 2-6 months old babies.This study was planned as randomized controlled experimental single-blind.
The population of the research will be 2-6 months old babies who come to Giresun Güce District State Hospital Family Health Center to receive DaBT-IPA-Hib vaccine between the dates of the research. The sample of the study will consist of infants who met the case selection criteria, accepted to participate in the study and were vaccinated between the specified dates.
As a result of the power analysis, it was determined that a total of 99 infants, 33 of whom were to be applied cold massage, 33 to be administered ShotBlocker©, and 33 to the control group, who were 2-6 months old to be administered DaBT-IPA-Hib vaccine, met the case selection criteria and agreed to participate in the study. Considering the possibility of case losses, a total of 108 babies, 36 in each group, are planned to be included in the study.
- Being tested
- Cold Massage Group, ShotBlocker© Group
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Massage GroupOther
Just before the application, it will be taken out of the cabinet and the area to be vaccinated will be massaged with rollers with back and forth movements.
ShotBlocker© GroupOther
It is a small flexible drug-free plastic tool. It is a small, flat-shaped instrument with a short, blunt, skin-contact ridge on the bottom and a hole in the center to inject. It is placed on the skin before injection. The protrusions on the inside do not harm the skin.
| Study group | Role | What they receive |
|---|---|---|
| Cold Massage Group | Experimental | Just before the application, it will be taken out of the cabinet and the area to be vaccinated will be massaged with rollers with back and forth movements. Receives: Other: Cold Massage Group |
| ShotBlocker© Group | Experimental | It is a small flexible drug-free plastic tool. It is a small, flat-shaped instrument with a short, blunt, skin-contact ridge on the bottom and a hole in the center to inject. It is placed on the skin before injection. The protrusions on the inside do not harm the skin. Receives: Other: ShotBlocker© Group |
| Control Group | No intervention | No intervention will be applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
crying
crying time
Measured: 1 minute before the procedure
crying
crying time will be measured and noted.
Measured: 1 minute after the procedure
SpO2
Physiological parameters
Measured: 1 minute before the procedure
SpO2
Physiological parameters
Measured: 1 minute after the procedure
Pulse
Physiological parameters
Measured: 1 minute before the procedure
Pulse
Physiological parameters
Measured: 1 minute after the procedure
Body temperature
Physiological parameters
Measured: 1 minute before the procedure
Body temperature
Physiological parameters
Measured: 1 minute after the procedure
FLACC Pain Scale (Face, Legs, Activity, Cry, Consolability Pain Scale)
The FLACC scale was first developed by Merkel et al.in 1997. In the research, it will be used to evaluate the pain levels of infants in the experimental and control groups before, during and after vaccination. The five behaviors ("face", "legs", "activity", "crying" and "consolation") evaluated on this scale are considered indicators of pain that can be detected and graded by an observer. Descriptors for each item are accepted as indicators of children's painful behavior. Each item is scored from 0 to two, resulting in a pain intensity score ranging from 0 to 10. And descriptors associated with each score level represent pain intensity.
Measured: 1 minute before the procedure
FLACC Pain Scale (Face, Legs, Activity, Cry, Consolability Pain Scale)
The FLACC scale was first developed by Merkel et al.in 1997. In the research, it will be used to evaluate the pain levels of infants in the experimental and control groups before, during and after vaccination. The five behaviors ("face", "legs", "activity", "crying" and "consolation") evaluated on this scale are considered indicators of pain that can be detected and graded by an observer. Descriptors for each item are accepted as indicators of children's painful behavior. Each item is scored from 0 to two, resulting in a pain intensity score ranging from 0 to 10. And descriptors associated with each score level represent pain intensity.
Measured: 1 minute after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start22 Nov 2022
- Primary completion30 Mar 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaccineStudies 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
- Model description
- This study was planned as randomized controlled experimental.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Kucuk Alemdar, Ordu University
- Investigators
- Dilek Küçük Alemdar, Principal investigator, Assoc. Dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752747
- Sponsor's protocol ID
- KAEK 07
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2023
- Last updated
- 19 Feb 2025
- 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 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Shotblocker and Cold Massage on Pain, Crying Time and Physiological Parameters During Vaccine Injection in Babies
- ClinicalTrials.gov ID
- NCT05752747
- Acronym / sponsor ID
- KAEK 07
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 3 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.
The aim of this study is to determine the effect of ShotBlocker© and cold massage on pain, crying time and physiological parameters during DaBT-IPA-Hib vaccine administration in 2-6 months old babies.
Detailed description
The aim of this study is to determine the effect of ShotBlocker© and cold massage on pain, crying time and physiological parameters during DaBT-IPA-Hib vaccine administration in 2-6 months old babies.This study was planned as randomized controlled experimental single-blind.
The population of the research will be 2-6 months old babies who come to Giresun Güce District State Hospital Family Health Center to receive DaBT-IPA-Hib vaccine between the dates of the research. The sample of the study will consist of infants who met the case selection criteria, accepted to participate in the study and were vaccinated between the specified dates.
As a result of the power analysis, it was determined that a total of 99 infants, 33 of whom were to be applied cold massage, 33 to be administered ShotBlocker©, and 33 to the control group, who were 2-6 months old to be administered DaBT-IPA-Hib vaccine, met the case selection criteria and agreed to participate in the study. Considering the possibility of case losses, a total of 108 babies, 36 in each group, are planned to be included in the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This study was planned as randomized controlled experimental.
| Arm | Type | Receives |
|---|---|---|
| Cold Massage Group | Experimental | Other: Cold Massage GroupJust before the application, it will be taken out of the cabinet and the area to be vaccinated will be massaged with rollers with back and forth movements. |
| ShotBlocker© Group | Experimental | Other: ShotBlocker© GroupIt is a small flexible drug-free plastic tool. It is a small, flat-shaped instrument with a short, blunt, skin-contact ridge on the bottom and a hole in the center to inject. It is placed on the skin before injection. The protrusions on the inside do not harm the skin. |
| Control Group | No intervention | –No intervention will be applied to the control group. |
Who may qualify
- Ages
- 2 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The baby is 2-6 months old,
- DaBT- IPA- Hib vaccine will be administered,
- The baby does not have a chronic disease,
- Parents must be at least primary school graduate,
- Parent's willingness to participate in the study.
Key exclusion criteria (3 listed)
- Having a congenital or neurological health problem,
- Have taken an analgesic drug in the last 4 hours,
- Babies with a body temperature above 37.5 will not be included 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 |
|---|---|---|
| Cold Massage GroupJust before the application, it will be taken out of the cabinet and the area to be vaccinated will be massaged with rollers with back and forth movements. | Other | Cold Massage Group |
| ShotBlocker© GroupIt is a small flexible drug-free plastic tool. It is a small, flat-shaped instrument with a short, blunt, skin-contact ridge on the bottom and a hole in the center to inject. It is placed on the skin before injection. The protrusions on the inside do not harm the skin. | Other | ShotBlocker© Group |
Primary outcome
crying
Time frame: 1 minute before the procedure
crying time
crying
Time frame: 1 minute after the procedure
crying time will be measured and noted.
SpO2
Time frame: 1 minute before the procedure
Physiological parameters
SpO2
Time frame: 1 minute after the procedure
Physiological parameters
Pulse
Time frame: 1 minute before the procedure
Physiological parameters
Pulse
Time frame: 1 minute after the procedure
Physiological parameters
Body temperature
Time frame: 1 minute before the procedure
Physiological parameters
Body temperature
Time frame: 1 minute after the procedure
Physiological parameters
FLACC Pain Scale (Face, Legs, Activity, Cry, Consolability Pain Scale)
Time frame: 1 minute before the procedure
The FLACC scale was first developed by Merkel et al.in 1997. In the research, it will be used to evaluate the pain levels of infants in the experimental and control groups before, during and after vaccination. The five behaviors ("face", "legs", "activity", "crying" and "consolation") evaluated on this scale are considered indicators of pain that can be detected and graded by an observer. Descriptors for each item are accepted as indicators of children's painful behavior. Each item is scored from 0 to two, resulting in a pain intensity score ranging from 0 to 10. And descriptors associated with each score level represent pain intensity.
FLACC Pain Scale (Face, Legs, Activity, Cry, Consolability Pain Scale)
Time frame: 1 minute after the procedure
The FLACC scale was first developed by Merkel et al.in 1997. In the research, it will be used to evaluate the pain levels of infants in the experimental and control groups before, during and after vaccination. The five behaviors ("face", "legs", "activity", "crying" and "consolation") evaluated on this scale are considered indicators of pain that can be detected and graded by an observer. Descriptors for each item are accepted as indicators of children's painful behavior. Each item is scored from 0 to two, resulting in a pain intensity score ranging from 0 to 10. And descriptors associated with each score level represent pain intensity.
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 19 Feb 2025.
- 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.
Dilek Küçük Alemdar principal investigator
Assoc. Dr.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cold Massage Group and ShotBlocker© Group in people with Vaccine and Pain, run by Ordu 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 5 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 19 Feb 2025. 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?
crying (time frame: 1 minute before the procedure). The study lists 10 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 19 Feb 2025.