Vaccine ReactionNCT05598372
Infant Pain During Vaccination and Maternal Anxiety
A study testing shotblocker and lullaby in people with Vaccine Reaction, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This research was planned to determine the effect of two different methods on infant pain during vaccination and mother anxiety.The study was planned as a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 1 month to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Reaction
- What is being tested?
- shotblocker and lullaby
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Oct 2022to 22 Dec 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 1 month to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The child does not have a disorder in the cognitive developmental area.
- It is time to apply the hepatitis B vaccine of the 6th month.
- Parent giving consent to participate in the study voluntarily and for their child to participate.
Who cannot join
- The child has a disorder in the cognitive developmental area.
- Failure to apply the 6th month hepatitis B vaccine.
- Parent's voluntarily participating in the study and not giving consent for the child's participation.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University Nursing of Faculty
Erzurum, Center, 25240
About this study
Official title: The Effect of Two Different Methods on Infant Pain During Vaccination and Maternal Anxiety: a Randomized Controlled Study
This research was planned to determine the effect of two different methods on infant pain during vaccination and mother anxiety.The study was planned as a randomized controlled trial. The universe of this research consists of parents and their babies who come to Hocabey Family Health Center in Erzincan Center to receive the hepatitis B dose between these dates according to the vaccination calendar. In this study, it is planned to apply shotblocker and lullaby.
Read the detailed description
Type of Study The study was planned as a randomized controlled trial. Population and Sample The universe of this research consists of parents and their babies who come to Hocabey Family Health Center in Erzincan Center to receive the hepatitis B dose between these dates according to the vaccination calendar.
Data Collection Tools Demographic Data Form, Neonatal Pain Scale and State Anxiety Scale Newborn Infant Pain Scale (NIPS): The scale used in the assessment of newborn pain consists of 6 categories. It was developed in 1993 and its validity and reliability in our country was made in 1999. The score obtained from the scale varies between 0-7. Scale ; It consists of five behavioral indicators including facial expression, arm movement, leg movement, crying, alertness, and a physiological indicator that includes breathing.
State Anxiety Inventory: The State Anxiety Scale was developed in 1970, and its Turkish validity and reliability study in our country was conducted in 1994. There are a total of 40 statements in the scale. The first twenty items measure the level of anxiety related to the situation, and each statement is "Not at all" (1), "Somewhat" (2), "Very"(3), "Totally"(4). Reverse coded items; Items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20. Points are added and subtracted according to the reverse and direct coded items in the scale. He states that 0-19 points obtained from the scale mean no anxiety, 20-39 points mean mild, 40-59 points mean moderate, 60-79 points mean severe anxiety, and individuals with a score of 60 and above need professional help.
Data Collection Ethics and institutional permissions After the data is received, it will be explained to the participants that the confidentiality of the data will be protected, that personal information will not be requested, that the study is on a voluntary basis, and they will be informed that they can terminate the study at any time. Adolescents who agree to participate in the study will fill in the data collection form, which will take approximately 10 minutes, based on personal notification.
Experimental process In this study, it is planned to apply shotblocker and lullaby. Shotblocker application is not a drug application, it is a small apparatus that performs the blocking process on peripheral nerves to reduce the pain with protruding shape. There is no harm in the application. Another application planned in the study is lullaby. In this application, it is aimed to reduce the baby's pain, which is the painful process, by making the mother who is closest to the baby sing a lullaby. It is very important to compare these two methods. Namely; The effectiveness of two natural and artificial applications will be compared. The fact that this study has not been done before will also provide an important data source to the literature. The planned study will be conducted with 30 lullabies, 30 shotblockers, and 30 babies who come to Hocabey Family Health Center to receive their 6th month Hepatitis B dose and their mothers as a control group to help measure the effectiveness of these two groups. In order to reduce the variables in the application, the nurse who performed the application will be kept constant. For the preliminary application, the principal researcher will be at the center for 1 week and will make observations.
Analysis of the data The data will be evaluated as a result of statistical analyzes using the SPSS package program in computer environment. Descriptive statistics will be displayed as numbers, percentages, and mean±standard deviation. Skewness and Kurtosis values will be checked if the data is suitable for normal distribution. ±1.5 will be taken as the normal distribution limit value. Chi-square test, variance analysis and Pearson correlation analysis will be used in the analysis of the variables. Statistical significance level will be accepted as p˂0.05 in all analyzes.
Research Ethics During the collection of research data, the principle of informed consent, the principle of respect for autonomy and the protection of confidentiality and confidentiality will be followed.
- Conditions
- Vaccine Reaction
- Being tested
- shotblocker, lullaby
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shotblockerBehavioural
infant pain during vaccination and mother anxiety
lullabyBehavioural
infant pain during vaccination and mother anxiety
| Study group | Role | What they receive |
|---|---|---|
| shotblocker | Experimental | infant pain during vaccination and mother anxiety Receives: Behavioral: shotblocker |
| lullaby | Experimental | infant pain during vaccination and mother anxiety Receives: Behavioral: lullaby |
| CONTROL | No intervention | not infant pain during vaccination and mother anxiety |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newborn Infant Pain Scale (NIPS)
The scale used in the assessment of newborn pain consists of 6 categories. It was developed in 1993 and its validity and reliability in our country was made in 1999. The score obtained from the scale varies between 0-7. Scale ; It consists of five behavioral indicators including facial expression, arm movement, leg movement, crying, alertness, and a physiological indicator that includes breathing.
Measured: 9 MONTHS
State Anxiety Inventory
The State Anxiety Scale was developed in 1970, and its Turkish validity and reliability study in our country was conducted in 1994. There are a total of 40 statements in the scale. The first twenty items measure the level of anxiety related to the situation, and each statement is "Not at all" (1), "Somewhat" (2), "Very"(3), "Totally"(4). Reverse coded items; Items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20. Points are added and subtracted according to the reverse and direct coded items in the scale. She states that 0-19 points obtained from the scale mean no anxiety, 20-39 points mean mild, 40-59 points mean moderate, 60-79 points mean severe anxiety, and individuals with a score of 60 and above need professional help.
Measured: 9 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start25 Oct 2022
- Primary completion13 Dec 2023
- Study completion22 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine ReactionStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ARZU SARIALİOĞLU, Ataturk University
- Investigators
- ARZU SARIALİOĞLU, PHD, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598372
- Sponsor's protocol ID
- E-88012460-050.01.04-208074
- Status last verified
- Jun 2024
- First submitted
- 25 Oct 2022
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: THE ARTICLE IS INTENDED TO BE SHARED AFTER IT IS PUBLISHED
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Methods on Infant Pain During Vaccination and Maternal Anxiety: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05598372
- Acronym / sponsor ID
- E-88012460-050.01.04-208074
- Conditions
- Vaccine Reaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 13 Dec 2023 (actual)
- Study completion
- 22 Dec 2024 (actual)
- First posted
- 28 Oct 2022 (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.
This research was planned to determine the effect of two different methods on infant pain during vaccination and mother anxiety.The study was planned as a randomized controlled trial. The universe of this research consists of parents and their babies who come to Hocabey Family Health Center in Erzincan Center to receive the hepatitis B dose between these dates according to the vaccination calendar. In this study, it is planned to apply shotblocker and lullaby.
Detailed description
Type of Study The study was planned as a randomized controlled trial. Population and Sample The universe of this research consists of parents and their babies who come to Hocabey Family Health Center in Erzincan Center to receive the hepatitis B dose between these dates according to the vaccination calendar.
Data Collection Tools Demographic Data Form, Neonatal Pain Scale and State Anxiety Scale Newborn Infant Pain Scale (NIPS): The scale used in the assessment of newborn pain consists of 6 categories. It was developed in 1993 and its validity and reliability in our country was made in 1999. The score obtained from the scale varies between 0-7. Scale ; It consists of five behavioral indicators including facial expression, arm movement, leg movement, crying, alertness, and a physiological indicator that includes breathing.
State Anxiety Inventory: The State Anxiety Scale was developed in 1970, and its Turkish validity and reliability study in our country was conducted in 1994. There are a total of 40 statements in the scale. The first twenty items measure the level of anxiety related to the situation, and each statement is "Not at all" (1), "Somewhat" (2), "Very"(3), "Totally"(4). Reverse coded items; Items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20. Points are added and subtracted according to the reverse and direct coded items in the scale. He states that 0-19 points obtained from the scale mean no anxiety, 20-39 points mean mild, 40-59 points mean moderate, 60-79 points mean severe anxiety, and individuals with a score of 60 and above need professional help.
Data Collection Ethics and institutional permissions After the data is received, it will be explained to the participants that the confidentiality of the data will be protected, that personal information will not be requested, that the study is on a voluntary basis, and they will be informed that they can terminate the study at any time. Adolescents who agree to participate in the study will fill in the data collection form, which will take approximately 10 minutes, based on personal notification.
Experimental process In this study, it is planned to apply shotblocker and lullaby. Shotblocker application is not a drug application, it is a small apparatus that performs the blocking process on peripheral nerves to reduce the pain with protruding shape. There is no harm in the application. Another application planned in the study is lullaby. In this application, it is aimed to reduce the baby's pain, which is the painful process, by making the mother who is closest to the baby sing a lullaby. It is very important to compare these two methods. Namely; The effectiveness of two natural and artificial applications will be compared. The fact that this study has not been done before will also provide an important data source to the literature. The planned study will be conducted with 30 lullabies, 30 shotblockers, and 30 babies who come to Hocabey Family Health Center to receive their 6th month Hepatitis B dose and their mothers as a control group to help measure the effectiveness of these two groups. In order to reduce the variables in the application, the nurse who performed the application will be kept constant. For the preliminary application, the principal researcher will be at the center for 1 week and will make observations.
Analysis of the data The data will be evaluated as a result of statistical analyzes using the SPSS package program in computer environment. Descriptive statistics will be displayed as numbers, percentages, and mean±standard deviation. Skewness and Kurtosis values will be checked if the data is suitable for normal distribution. ±1.5 will be taken as the normal distribution limit value. Chi-square test, variance analysis and Pearson correlation analysis will be used in the analysis of the variables. Statistical significance level will be accepted as p˂0.05 in all analyzes.
Research Ethics During the collection of research data, the principle of informed consent, the principle of respect for autonomy and the protection of confidentiality and confidentiality will be followed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| shotblocker | Experimental | Behavioral: shotblockerinfant pain during vaccination and mother anxiety |
| lullaby | Experimental | Behavioral: lullabyinfant pain during vaccination and mother anxiety |
| CONTROL | No intervention | –not infant pain during vaccination and mother anxiety |
Who may qualify
- Ages
- 1 month to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The child does not have a disorder in the cognitive developmental area.
- It is time to apply the hepatitis B vaccine of the 6th month.
- Parent giving consent to participate in the study voluntarily and for their child to participate.
Key exclusion criteria (3 listed)
- The child has a disorder in the cognitive developmental area.
- Failure to apply the 6th month hepatitis B vaccine.
- Parent's voluntarily participating in the study and not giving consent for the child's participation.
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 |
|---|---|---|
| shotblockerinfant pain during vaccination and mother anxiety | Behavioural | shotblocker |
| lullabyinfant pain during vaccination and mother anxiety | Behavioural | lullaby |
Primary outcome
Newborn Infant Pain Scale (NIPS)
Time frame: 9 MONTHS
The scale used in the assessment of newborn pain consists of 6 categories. It was developed in 1993 and its validity and reliability in our country was made in 1999. The score obtained from the scale varies between 0-7. Scale ; It consists of five behavioral indicators including facial expression, arm movement, leg movement, crying, alertness, and a physiological indicator that includes breathing.
State Anxiety Inventory
Time frame: 9 MONTHS
The State Anxiety Scale was developed in 1970, and its Turkish validity and reliability study in our country was conducted in 1994. There are a total of 40 statements in the scale. The first twenty items measure the level of anxiety related to the situation, and each statement is "Not at all" (1), "Somewhat" (2), "Very"(3), "Totally"(4). Reverse coded items; Items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20. Points are added and subtracted according to the reverse and direct coded items in the scale. She states that 0-19 points obtained from the scale mean no anxiety, 20-39 points mean mild, 40-59 points mean moderate, 60-79 points mean severe anxiety, and individuals with a score of 60 and above need professional help.
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 17 Mar 2025.
- Individual participant dataSharing planned: No. THE ARTICLE IS INTENDED TO BE SHARED AFTER IT IS PUBLISHED
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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.
ARZU SARIALİOĞLU, PHD study director
Ataturk 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 lullaby in people with Vaccine Reaction, run by Ataturk 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 3 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 17 Mar 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?
Newborn Infant Pain Scale (NIPS) (time frame: 9 MONTHS). 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 17 Mar 2025.