PainNCT06886412
Non-Pharmacological Methods for Reducing Pain During Vaccination in Infants
A study testing Maternal Holding Intervention Group and Breast Feeding Intervention Group in people with Pain and Breast Feeding, run by University of Yalova at 1 site in Turkey (Türkiye).
Trial summary
Pain management in infants is a medical responsibility of all members of the healthcare team, and nurses hold a privileged role in this regard. The primary goal of pain management is to accurately assess and identify the infant's pain at an early stage, support the development of coping mechanisms through both… Read more about this study
- Who is it for?
- Ages 1 month to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Pain, Breast Feeding, Maternal Behavior
- What is being tested?
- Maternal Holding Intervention Group and Breast Feeding Intervention Group
- 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
- 2 Feb 2025to 25 Apr 2025
- 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
- Being healthy,
- Aged between 4 weeks and 6 months,
- Parents have given verbal and written consent to participate in the study,
- Born at term (37 weeks of gestation or later),
- Scheduled for vaccination under the Ministry of Health's vaccination program,
- Not having taken analgesics/antipyretics in the last 4 hours before the procedure,
- Having a normal body temperature (between 36.5°C and 37.1°C).
Who cannot join
- Having a chronic or mental illness, or a congenital anomaly,
- Being older than 6 months,
- Having a body temperature above 37.1°C,
- Receiving analgesics, sedatives, or any other medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Breastfeeding and Maternal Holding on Reducing Pain During Vaccination in Infants
Pain management in infants is a medical responsibility of all members of the healthcare team, and nurses hold a privileged role in this regard. The primary goal of pain management is to accurately assess and identify the infant's pain at an early stage, support the development of coping mechanisms through both pharmacological and non-pharmacological methods, and minimize the pain experience as much as possible. Pain management achieved through non-pharmacological interventions constitutes a safe, non-invasive, cost-effective, and independently performed nursing practice. This randomized controlled study was conducted to determine the effect of non-pharmacological methods, specifically maternal holding and breastfeeding, on reducing pain during vaccination in infants.
- Conditions
- Pain, Breast Feeding, Maternal Behavior
- Being tested
- Maternal Holding Intervention Group, Breast Feeding Intervention Group
- Keywords
- Pain, Vaccines, Nursing, Breastfeeding, Maternal holding, Infants
- Medical subject headings
- Pain, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal Holding Intervention GroupBehavioural
The infant is required to be held in the mother's arms before, during, and after the procedure. The maternal holding method will be shown or explained to the mother by the researchers.
Breast Feeding Intervention GroupBehavioural
The infant's mother is instructed to begin breastfeeding 2 minutes before the procedure, continuing during and after the procedure. The breastfeeding position for the infant will be shown or explained to the mother by the researchers.
| Study group | Role | What they receive |
|---|---|---|
| Maternal Holding Group | Experimental | Five minutes before the vaccination procedure, the infant will be handed to the mother in a position suitable for vaccination and will remain in her arms throughout the procedure. It will be checked that the infant's diaper has been changed..The mother will be informed about the importance of stabilizing the leg to be vaccinated during the procedure and will be instructed to hold the infant in a comfortable position. The mother will hold the infant in her lap, using one arm and hand to secure the infant's arms and the other arm and hand to hold the infant's legs. The infant's pain level will be assessed using the Neonatal Infant Pain Scale (NIPS) before, during, and after the vaccination procedure. Crying duration will be measured using a mobile phone stopwatch and recorded in the application record form. The final NIPS assessment and crying duration measurement will be performed 3 minutes after the procedure. Receives: Behavioral: Maternal Holding Intervention Group |
| Breast Feeding Group | Experimental | Before the vaccination procedure, the infant and mother will be taken to the vaccination room. The infant's diaper will be checked to ensure it has been changed. The mother will be asked whether the infant has been fed at least 30 minutes before the procedure. The mother will be instructed to sit comfortably on the examination table with her back supported against the wall. The mother will then take the infant in her arms, and the infant will be placed in a cradle hold breastfeeding position. The infant will be handed to the mother 2 minutes before the procedure, and breastfeeding will begin. The infant's pain level will be assessed using the Neonatal Infant Pain Scale (NIPS) before, during, and after the vaccination procedure. Crying duration will be measured using a mobile phone stopwatch and recorded in the application record form. The final NIPS assessment and crying duration measurement will be performed 3 minutes after the procedure. Receives: Behavioral: Breast Feeding Intervention Group |
| Control Group | No intervention | The infants in the control group will receive their vaccinations in the same manner as routine vaccination procedures. Before the vaccination procedure, the infant and their parent will be taken to the room where the procedure will take place, and the infant will be laid on the examination table. During the procedure, the mother will remain next to her infant. To restrict the movement of the infant's legs during the vaccination, the nurse will stabilize the infant's leg with one hand while performing the procedure with the other hand. No non-pharmacological methods will be applied during the procedure. The infant's pain level will be assessed using the Neonatal Infant Pain Scale (NIPS) before, during, and after the vaccination. Crying duration will be measured using a mobile phone stopwatch and recorded in the application record form. The final NIPS assessment and crying duration measurement will be performed 3 minutes after the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pain and crying duration in the infant held in the mother's arms during the vaccination procedure
The pain of the infant held in the mother's arms will be measured using the Neonatal Infant Pain Scale 2 minutes before the procedure, during the procedure, and 3 minutes after the procedure. The crying duration before and after the procedure will be measured using a stopwatch.
Measured: Two minutes before the procedure, during the procedure, and three minutes after the procedure.
Evaluation of pain and crying duration in the infant held in the breast feeding during the vaccination procedure
The pain of the infant using the breastfeeding method will be measured using the Neonatal Infant Pain Scale 2 minutes before the procedure, during the procedure, and 2 minutes after the procedure. The crying duration before and after the procedure will be measured using a stopwatch.
Measured: Two minutes before the procedure, during the procedure, and three minutes 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 posted20 Mar 2025
- Study start2 Feb 2025
- Primary completion4 Apr 2025
- Study completion25 Apr 2025
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled and quasi-experimental research
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Yalova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel AVÇİN, University of Yalova
- Investigators
- EMEL AVÇİN, Doctor, Principal investigator, University of Yalova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886412
- Sponsor's protocol ID
- Emel Avcin Pain
- Status last verified
- Jul 2025
- First submitted
- 14 Mar 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Breastfeeding and Maternal Holding on Reducing Pain During Vaccination in Infants
- ClinicalTrials.gov ID
- NCT06886412
- Acronym / sponsor ID
- Emel Avcin Pain
- Conditions
- Pain, Breast Feeding, Maternal Behavior
- Keywords
- Pain, Vaccines, Nursing, Breastfeeding, Maternal holding, Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Study start
- 2 Feb 2025 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 20 Mar 2025 (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.
Pain management in infants is a medical responsibility of all members of the healthcare team, and nurses hold a privileged role in this regard. The primary goal of pain management is to accurately assess and identify the infant's pain at an early stage, support the development of coping mechanisms through both pharmacological and non-pharmacological methods, and minimize the pain experience as much as possible. Pain management achieved through non-pharmacological interventions constitutes a safe, non-invasive, cost-effective, and independently performed nursing practice. This randomized controlled study was conducted to determine the effect of non-pharmacological methods, specifically maternal holding and breastfeeding, on reducing pain during vaccination in infants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
- Model description
- Randomized controlled and quasi-experimental research
| Arm | Type | Receives |
|---|---|---|
| Maternal Holding Group | Experimental | Behavioral: Maternal Holding Intervention GroupFive minutes before the vaccination procedure, the infant will be handed to the mother in a position suitable for vaccination and will remain in her arms throughout the procedure. It will be checked that the infant's diaper has been changed..The mother will be informed about the importance of stabilizing the leg to be vaccinated during the procedure and will be instructed to hold the infant in a comfortable position. The mother will hold the infant in her lap, using one arm and hand to secure the infant's arms and the other arm and hand to hold the infant's legs. The infant's pain level will be assessed using the Neonatal Infant Pain Scale (NIPS) before, during, and after the vaccination procedure. Crying duration will be measured using a mobile phone stopwatch and recorded in the application record form. The final NIPS assessment and crying duration measurement will be performed 3 minutes after the procedure. |
| Breast Feeding Group | Experimental | Behavioral: Breast Feeding Intervention GroupBefore the vaccination procedure, the infant and mother will be taken to the vaccination room. The infant's diaper will be checked to ensure it has been changed. The mother will be asked whether the infant has been fed at least 30 minutes before the procedure. The mother will be instructed to sit comfortably on the examination table with her back supported against the wall. The mother will then take the infant in her arms, and the infant will be placed in a cradle hold breastfeeding position. The infant will be handed to the mother 2 minutes before the procedure, and breastfeeding will begin. The infant's pain level will be assessed using the Neonatal Infant Pain Scale (NIPS) before, during, and after the vaccination procedure. Crying duration will be measured using a mobile phone stopwatch and recorded in the application record form. The final NIPS assessment and crying duration measurement will be performed 3 minutes after the procedure. |
| Control Group | No intervention | –The infants in the control group will receive their vaccinations in the same manner as routine vaccination procedures. Before the vaccination procedure, the infant and their parent will be taken to the room where the procedure will take place, and the infant will be laid on the examination table. During the procedure, the mother will remain next to her infant. To restrict the movement of the infant's legs during the vaccination, the nurse will stabilize the infant's leg with one hand while performing the procedure with the other hand. No non-pharmacological methods will be applied during the procedure. The infant's pain level will be assessed using the Neonatal Infant Pain Scale (NIPS) before, during, and after the vaccination. Crying duration will be measured using a mobile phone stopwatch and recorded in the application record form. The final NIPS assessment and crying duration measurement will be performed 3 minutes after the procedure. |
Who may qualify
- Ages
- 1 month to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Being healthy,
- Aged between 4 weeks and 6 months,
- Parents have given verbal and written consent to participate in the study,
- Born at term (37 weeks of gestation or later),
- Scheduled for vaccination under the Ministry of Health's vaccination program,
Key exclusion criteria (4 listed)
- Having a chronic or mental illness, or a congenital anomaly,
- Being older than 6 months,
- Having a body temperature above 37.1°C,
- Receiving analgesics, sedatives, or any other medication.
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 |
|---|---|---|
| Maternal Holding Intervention GroupThe infant is required to be held in the mother's arms before, during, and after the procedure. The maternal holding method will be shown or explained to the mother by the researchers. | Behavioural | Maternal Holding Group |
| Breast Feeding Intervention GroupThe infant's mother is instructed to begin breastfeeding 2 minutes before the procedure, continuing during and after the procedure. The breastfeeding position for the infant will be shown or explained to the mother by the researchers. | Behavioural | Breast Feeding Group |
Primary outcome
Evaluation of pain and crying duration in the infant held in the mother's arms during the vaccination procedure
Time frame: Two minutes before the procedure, during the procedure, and three minutes after the procedure.
The pain of the infant held in the mother's arms will be measured using the Neonatal Infant Pain Scale 2 minutes before the procedure, during the procedure, and 3 minutes after the procedure. The crying duration before and after the procedure will be measured using a stopwatch.
Evaluation of pain and crying duration in the infant held in the breast feeding during the vaccination procedure
Time frame: Two minutes before the procedure, during the procedure, and three minutes after the procedure.
The pain of the infant using the breastfeeding method will be measured using the Neonatal Infant Pain Scale 2 minutes before the procedure, during the procedure, and 2 minutes after the procedure. The crying duration before and after the procedure will be measured using a stopwatch.
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 15 Jul 2025.
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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.
EMEL AVÇİN, Doctor principal investigator
University of Yalova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal Holding Intervention Group and Breast Feeding Intervention Group in people with Pain and Breast Feeding, run by University of Yalova 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 7 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 15 Jul 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?
Evaluation of pain and crying duration in the infant held in the mother's arms during the vaccination procedure (time frame: Two minutes before the procedure, during the procedure, and three minutes after the procedure.). 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 15 Jul 2025.