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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT05598372
Study groupRoleWhat they receive
shotblockerExperimentalinfant pain during vaccination and mother anxiety
Receives: Behavioral: shotblocker
lullabyExperimentalinfant pain during vaccination and mother anxiety
Receives: Behavioral: lullaby
CONTROLNo interventionnot infant pain during vaccination and mother anxiety

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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.

  1. First posted28 Oct 2022
  2. Study start25 Oct 2022
  3. Primary completion13 Dec 2023
  4. Study completion22 Dec 2024

Resources

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)
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

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.

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