PainNCT02808637
Vaccine-Related Pain in Infants
A study testing Manual Pressure, Rapid Injection without Aspiration and Manual Pressure + Rapid Injection without Aspiration in people with Pain, run by Çankırı Karatekin University.
Trial summary
This is a randomized double-blind controlled study and was performed to compare effects of rapid injection without aspiration and 10-second manual pressure before injection on pain severity and crying time in 4-6-month-old infants given the vaccine DTaP/IPV/Hib. Read more about this study
- Who is it for?
- Ages 4 to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Manual Pressure, Rapid Injection without Aspiration and Manual Pressure + Rapid Injection without Aspiration
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jan 2016
- 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 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants who were aged 4-6 months, had the percentiles of 3P - 97P, were born at term and were not given any analgesics before immunization and whose mothers gave written informed consent were included.
Who cannot join
- Infants whose percentiles were below 3P and above 97P and who had acute infectious diseases, underwent topical anesthesia and/or took analgesics were excluded from the study.
About this study
This is a randomized double-blind controlled study and was performed to compare effects of rapid injection without aspiration and 10-second manual pressure before injection on pain severity and crying time in 4-6-month-old infants given the vaccine DTaP/IPV/Hib.
The study population included all the infants presenting for DTaP/IPV/Hib to two family health centers between April and August in 2015. The study sample included 128 infants based on confidence interval of 95% and statistical power of 80%. The sample was divided into four groups; i.e. manual pressure, rapid injection without aspiration, manual pressure combined with rapid injection without aspiration and control groups. There were 32 infants in each group. Gender was adjusted in all groups. Stratified and block randomizations were used.
Read the detailed description
Study design: this is an experimental, double-blind, randomized controlled trial.
Study population and study sample: The study was conducted in two family health centers of Cankiri Public Health Directorate, Turkey, between April and August in 2015. The study population included infants aged 4-6 months and presenting to the family health centers for the second and third doses of DTaP/IPV/Hib. The study sample comprised of 128 infants based on confidence interval of 95% and statistical power of 80%. Analysis made at the end of the study showed a statistical power of 0.83 based on confidence interval of 95%.
Outcome Measures
Pain severity: Video recordings obtained were evaluated by two pain specialists separately by using Neonatal Infant Pain Scale. The specialists were blinded to the groups to eliminate possible mistakes in observations and the possibility of taking sides and to avoid bias. The scores assigned by the specialists were used to determine pain scores before, during and after vaccine injections.
Crying time: Video recordings taken were watched by the same researcher and crying time before, during and after vaccine injections was calculated for each infant.
Physiological Changes (heart rate and oxygen saturation): the probe of pulse oximetry was attached to the foot not injected vaccine to measure oxygen saturation and heart rate before, during and after the injections in each child.
- Conditions
- Pain
- Being tested
- Manual Pressure, Rapid Injection without Aspiration, Manual Pressure + Rapid Injection without Aspiration, Control
- Keywords
- Pain management, vaccination, manual pressure, needle aspiration
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual PressureOther
First, the infants were seated on their mothers' knees. Next, 10-second manual pressure was applied on the vaccine injection site. Then DTaP/IPV/Hib was administered in accordance with the conventional injection technique.
Rapid Injection without AspirationOther
First, the infants were seated on their mothers' knees. Then DTaP/IPV/Hib was administered by using rapid injection without aspiration technique.
Manual Pressure + Rapid Injection without AspirationOther
First, the infants were seated on their mothers' knees. Next, 10-second manual pressure was applied on the vaccine injection site. Then DTaP/IPV/Hib was administered by using the rapid injection without aspiration technique.
ControlOther
First, the infants were seated on their mothers' knees. Then DTaP/IPV/Hib was administered by using the conventional injection technique.
| Study group | Role | What they receive |
|---|---|---|
| Manual Pressure | Experimental | Not described Receives: Other: Manual Pressure |
| Rapid Injection without Aspiration | Experimental | Not described Receives: Other: Rapid Injection without Aspiration |
| Manual Pressure + Rapid Injection without Aspiration | Experimental | Not described Receives: Other: Manual Pressure + Rapid Injection without Aspiration |
| Control | Experimental | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain severity
Video recordings obtained were evaluated by two pain specialists separately by using NIPS. The specialists were blinded to the groups to eliminate possible mistakes in observations and the possibility of taking sides and to avoid bias. The scores assigned by the specialists were used to determine pain scores before, during and after vaccine injections. Pain severity, were expressed as the average score NIPS. When the opportunity to observe the baby again during the data collection and it was observed that no adverse effects. Therefore study has been completed with the same 128 babies.
Measured: 6 MONTHS
Crying time
Video recordings taken were watched by the same researcher and crying time (sec) before, during and after vaccine injections was calculated for each infant. When the opportunity to observe the baby again during the data collection and it was observed that no adverse effects. Therefore study has been completed with the same 128 babies.
Measured: 6 MONTHS
Physiological Changes (heart rate and oxygen saturation)
the probe of pulse oximetry was attached to the foot not injected vaccine to measure oxygen saturation (%) and heart rate (min) before, during and after the injections in each child. When the opportunity to observe the baby again during the data collection and it was observed that no adverse effects. Therefore study has been completed with the same 128 babies.
Measured: 6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startApr 2015
- Primary completionAug 2015
- Study completionJan 2016
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
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, İLKNUR GÖL, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808637
- Sponsor's protocol ID
- CANKIRI KARATEKIN UNIVERSITY
- Status last verified
- Jun 2016
- First submitted
- 10 Jun 2016
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccine-Related Pain in Infants
- ClinicalTrials.gov ID
- NCT02808637
- Acronym / sponsor ID
- CANKIRI KARATEKIN UNIVERSITY
- Conditions
- Pain
- Keywords
- Pain management, vaccination, manual pressure, needle aspiration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- Apr 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 22 Jun 2016 (estimated)
- 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.
This is a randomized double-blind controlled study and was performed to compare effects of rapid injection without aspiration and 10-second manual pressure before injection on pain severity and crying time in 4-6-month-old infants given the vaccine DTaP/IPV/Hib.
The study population included all the infants presenting for DTaP/IPV/Hib to two family health centers between April and August in 2015. The study sample included 128 infants based on confidence interval of 95% and statistical power of 80%. The sample was divided into four groups; i.e. manual pressure, rapid injection without aspiration, manual pressure combined with rapid injection without aspiration and control groups. There were 32 infants in each group. Gender was adjusted in all groups. Stratified and block randomizations were used.
Detailed description
Study design: this is an experimental, double-blind, randomized controlled trial.
Study population and study sample: The study was conducted in two family health centers of Cankiri Public Health Directorate, Turkey, between April and August in 2015. The study population included infants aged 4-6 months and presenting to the family health centers for the second and third doses of DTaP/IPV/Hib. The study sample comprised of 128 infants based on confidence interval of 95% and statistical power of 80%. Analysis made at the end of the study showed a statistical power of 0.83 based on confidence interval of 95%.
Outcome Measures
Pain severity: Video recordings obtained were evaluated by two pain specialists separately by using Neonatal Infant Pain Scale. The specialists were blinded to the groups to eliminate possible mistakes in observations and the possibility of taking sides and to avoid bias. The scores assigned by the specialists were used to determine pain scores before, during and after vaccine injections.
Crying time: Video recordings taken were watched by the same researcher and crying time before, during and after vaccine injections was calculated for each infant.
Physiological Changes (heart rate and oxygen saturation): the probe of pulse oximetry was attached to the foot not injected vaccine to measure oxygen saturation and heart rate before, during and after the injections in each child.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Manual Pressure | Experimental | Other: Manual Pressure |
| Rapid Injection without Aspiration | Experimental | Other: Rapid Injection without Aspiration |
| Manual Pressure + Rapid Injection without Aspiration | Experimental | Other: Manual Pressure + Rapid Injection without Aspiration |
| Control | Experimental | Other: Control |
Who may qualify
- Ages
- 4 to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy infants who were aged 4-6 months, had the percentiles of 3P - 97P, were born at term and were not given any analgesics before immunization and whose mothers gave written informed consent were included.
Key exclusion criteria (1 listed)
- Infants whose percentiles were below 3P and above 97P and who had acute infectious diseases, underwent topical anesthesia and/or took analgesics were excluded from 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 |
|---|---|---|
| Manual PressureFirst, the infants were seated on their mothers' knees. Next, 10-second manual pressure was applied on the vaccine injection site. Then DTaP/IPV/Hib was administered in accordance with the conventional injection technique. | Other | Manual Pressure |
| Rapid Injection without AspirationFirst, the infants were seated on their mothers' knees. Then DTaP/IPV/Hib was administered by using rapid injection without aspiration technique. | Other | Rapid Injection without Aspiration |
| Manual Pressure + Rapid Injection without AspirationFirst, the infants were seated on their mothers' knees. Next, 10-second manual pressure was applied on the vaccine injection site. Then DTaP/IPV/Hib was administered by using the rapid injection without aspiration technique. | Other | Manual Pressure + Rapid Injection without Aspiration |
| ControlFirst, the infants were seated on their mothers' knees. Then DTaP/IPV/Hib was administered by using the conventional injection technique. | Other | Control |
Primary outcome
Pain severity
Time frame: 6 MONTHS
Video recordings obtained were evaluated by two pain specialists separately by using NIPS. The specialists were blinded to the groups to eliminate possible mistakes in observations and the possibility of taking sides and to avoid bias. The scores assigned by the specialists were used to determine pain scores before, during and after vaccine injections. Pain severity, were expressed as the average score NIPS. When the opportunity to observe the baby again during the data collection and it was observed that no adverse effects. Therefore study has been completed with the same 128 babies.
Crying time
Time frame: 6 MONTHS
Video recordings taken were watched by the same researcher and crying time (sec) before, during and after vaccine injections was calculated for each infant. When the opportunity to observe the baby again during the data collection and it was observed that no adverse effects. Therefore study has been completed with the same 128 babies.
Physiological Changes (heart rate and oxygen saturation)
Time frame: 6 MONTHS
the probe of pulse oximetry was attached to the foot not injected vaccine to measure oxygen saturation (%) and heart rate (min) before, during and after the injections in each child. When the opportunity to observe the baby again during the data collection and it was observed that no adverse effects. Therefore study has been completed with the same 128 babies.
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 22 Jun 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Pressure, Rapid Injection without Aspiration and Manual Pressure + Rapid Injection without Aspiration in people with Pain, run by Çankırı Karatekin University.
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 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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 severity (time frame: 6 MONTHS). 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 22 Jun 2016.