NewbornNCT06741670
Effects of Three Different Methods in Reducing Pain During Heel Blood Collection
A study testing Breastfeeding, Vibration and Breastfeeding+Vibration in people with Newborn and Pain Management, run by Burdur Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
Trial summary
This prospective study is planned as a randomized controlled study with the purpose of determining the effect of Breastfeeding, Vibration, and Breastfeeding+Vibration on pain levels during heel blood collection on healthy term newborn's. Read more about this study
- Who is it for?
- Ages 2 to 4 daysHealthy volunteers can take part
- Conditions the study is for
- Newborn, Pain Management, Breastfeeding
- What is being tested?
- Breastfeeding, Vibration and Breastfeeding+Vibration
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2024to 4 Jul 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 2 to 4 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Parents who volunteered and gave consent to participate in the research
- Full term neonates (38-42 weeks of gestation)
- Underwent heel stick blood drawing for routine metabolic screening,
- Aged 2 to 4 days
- Passed the hearing screening
- Birth weight between 2500-4400 grams
- Parents who know how to read, write and speak Turkish.
Who cannot join
- Parents with any mental problems
- Infants with any chronic disease and congenital anomalies.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Burdur Mehmet Akif Ersoy University
Burdur, Bucak, 15030
About this study
Official title: Determination of the Effects of Three Different Methods in Reducing Pain During Heel Blood Collection; Breastfeeding, Vibration, and Breastfeeding+Vibration: A Randomized Controlled Study
This prospective study is planned as a randomized controlled study with the purpose of determining the effect of Breastfeeding, Vibration, and Breastfeeding+Vibration on pain levels during heel blood collection on healthy term newborn's.
Read the detailed description
Among the non-pharmacological methods frequently used to reduce the effects of invasive interventions on the newborn; Practices such as reducing environmental stimuli, individualized developmental care, music therapy, breast milk, pacifier giving, sucrose, non-nutritive sucking, oral sucrose, kangaroo care, facilitated tucking position, and sweet solutions, massage and touching, positioning, nesting, kangaroo care, fetal positioning are included.
This study is a prospective, randomized and controlled trial. In this study aim, the effect of Breastfeeding, Vibration, and Breastfeeding+Vibration during heel blood collection on the pain levels in healthy term newborn's will be examined.
Sample of the study consisted of a total of 192 newborns who met the sample selection criteria and were selected via randomization method. Newborns were divided into four groups; Breastfeeding group (n=48), Vibration group (n=48), Breastfeeding+Vibration group (n=48), and Control group (n=48).
Data were collected using the Infant-family Information Form and NIPS-Neonatal Infant Pain Scale. Data collection All blood sampling was performed in a quiet nursery room between 09:00 AM and 11:00 AM, 1-2 hours after breastfeeding, the normal time when infants undergo heel stick for routine blood collection for metabolic screening. Blood collection was performed in a standardized manner by the same nurse who has a minimum of 5 years' experience in the performance heel stick and had no conflict of interest. A pediatrician made the clinical decision for heel stick.
Before the procedure, the newborns were kept in a quiet room far away from the cries of other babies. The infants' diapers were changed before procedure. For the heel stick procedure, the antiseptic solution (70% alcohol), heel stick method, heel region for sampling (the outer right side of the ball), needle (21-G needle), and environmental factors such as heat, light, and noise were all standardized. The whole procedure was video-recorded until three minutes after the procedure.
At the beginning of the study, the parents of the newborns were informed about the aim and content of the research, and parental approval was obtained. Neonatal and family demographics were collected using self-report information forms, which included medical history, mother's gestational age, neonatal age, sex, birth weight, duration of sampling, total crying time, processing time, and the time from the start of the first cry to the first crying during the process.
All blood sampling in the study was performed for clinical purposes, such as newborn metabolic screening tests, which were taken on the second to third days following birth. The standard protocol for blood sampling involved swabbing the heel with a small gauze pad with disinfectant, lancing the heel, and then gently squeezing the heel intermittently until the amount of blood required for clinical use was collected.
All procedures performed in the experimental and control groups were video recorded by the researcher from the beginning of the procedure. After the procedure the newborns' pain levels and crying duration were evaluated using the video recordings. Assessment of pain was conducted independently by the investigator and the nurse using NIPS. At the same time, the newborns' total procedural crying time, the duration of the procedure, and the first calming time were recorded. The total crying time of the newborns was measured from the start of crying due to heel stick to the complete cessation of crying. The time of the procedure was measured from the beginning to the end of the heel stick procedure. The calming time was measured from the time of the first cry to the first calming time.
- Conditions
- Newborn, Pain Management, Breastfeeding, Vibration, Wounds, Penetrating, Needlestick Injuries
- Being tested
- Breastfeeding, Vibration, Breastfeeding+Vibration
- Keywords
- Newborn, Pain, Breastfeeding, Vibration, Heel Blood Collection
- Medical subject headings
- Agnosia, Breast Feeding, Wounds, Penetrating, Needlestick Injuries, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreastfeedingBehavioural
The routine practice of the Breastfeeding Group is to place the infants in their mother's arms and start breastfeeding 1 minute before the procedure. Then, the nurse will take the heel blood.
VibrationDevice
The vibration device was placed on the infant's left extremity in the mid/lateral region just below the knee where the sural nerve passes. The device was secured to the extremity with a gauze bandage. The infants in the Vibration Group will be placed in their mother's arms and vibration will be applied 30 seconds before the routine application, and vibration will be applied during the 10-second waiting phase while the nurse performs the heel prick blood collection procedure.
Breastfeeding+VibrationOther
The vibration device was placed on the infant's left extremity in the mid/lateral region just below the knee where the sural nerve passes. The device was secured to the extremity with a gauze bandage.
The routine practice for the Breastfeeding+Vibration Group babies will be started by holding them in their mother's arms and breastfeeding will be started 1 minute before the application. At the same time, vibration will be applied 30 seconds before the application and vibration will be applied in a 10-second waiting phase while the nurse performs the heel prick procedure.
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding Group | Experimental | Breastfeeding was applied to the infants in this group before and during the heel lance procedure. Receives: Behavioral: Breastfeeding |
| Vibration Group | Experimental | Vibration was applied to the infants in this group before and during the heel lance procedure. Receives: Device: Vibration |
| Breastfeeding+Vibration Group | Experimental | Breastfeeding+Vibration was applied to the infants in this group before and during the heel lance procedure. Receives: Other: Breastfeeding+Vibration |
| Control Group | No intervention | In this group, infants received routine heel blood collection procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIPS (Neonatal Infant Pain Scale)
It was developed by Lawrence et al. in 1993 to evaluate interventional pain in newborns (Lawrence et al, 1993). Its Turkish adaptation was made by Akdovan and Yıldırım in 1999. NIPS is an assessment tool that focuses on six behavioral responses of newborns: facial expressions, crying, breathing, arm movements, leg movements, and arousal. A score between 0 and 7 is obtained from the scale, and as the score obtained from the scale increases, the pain of newborns also increases. In the Turkish adaptation study of the scale, the Cronbach's alpha value was calculated as 0.83 before the procedure, 0.83 during the procedure and 0.86 after the procedure.
Measured: average 5 minutes) during the heel blood collection procedures (1 minute before the heel lance procedure (T-1 minute), during the procedure (T+0 second), and 2 minutes (T+2 minutes)]
Secondary outcomes (3)
Crying times
Duration of crying were recorded.
Measured: [Time Frame: during the heel blood collection procedures (average 5 minutes)]
Processing time
Duration of heel blood collection procedure were recorded.
Measured: [Time Frame: during the heel blood collection procedures (average 5 minutes)]
The time to first calming
The calming time was measured from the time of the first cry to the first calming time.
Measured: [Time Frame: Procedure (The calming time was measured from the time of the first cry to the first calming time.) (average 5 minutes)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start2 Sep 2024
- Primary completion29 May 2025
- Study completion4 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NewbornStudies 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
- Parallel Assignment Prospective, randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burdur Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selda Ateş Beşirik, Burdur Mehmet Akif Ersoy University
- Investigators
- Selda Ateş Beşirik, Principal investigator, Burdur Mehmet Akif Ersoy University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06741670
- Sponsor's protocol ID
- GO 2024/412
- Status last verified
- Jul 2025
- First submitted
- 15 Dec 2024
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this study, after deidentification, will be shared with researchers who provide a methodologically sound proposal.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Effects of Three Different Methods in Reducing Pain During Heel Blood Collection; Breastfeeding, Vibration, and Breastfeeding+Vibration: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06741670
- Acronym / sponsor ID
- GO 2024/412
- Conditions
- Newborn, Pain Management, Breastfeeding, Vibration, Wounds, Penetrating, Needlestick Injuries
- Keywords
- Newborn, Pain, Breastfeeding, Vibration, Heel Blood Collection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Burdur Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 2 Sep 2024 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 4 Jul 2025 (actual)
- First posted
- 19 Dec 2024 (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 prospective study is planned as a randomized controlled study with the purpose of determining the effect of Breastfeeding, Vibration, and Breastfeeding+Vibration on pain levels during heel blood collection on healthy term newborn's.
Detailed description
Among the non-pharmacological methods frequently used to reduce the effects of invasive interventions on the newborn; Practices such as reducing environmental stimuli, individualized developmental care, music therapy, breast milk, pacifier giving, sucrose, non-nutritive sucking, oral sucrose, kangaroo care, facilitated tucking position, and sweet solutions, massage and touching, positioning, nesting, kangaroo care, fetal positioning are included.
This study is a prospective, randomized and controlled trial. In this study aim, the effect of Breastfeeding, Vibration, and Breastfeeding+Vibration during heel blood collection on the pain levels in healthy term newborn's will be examined.
Sample of the study consisted of a total of 192 newborns who met the sample selection criteria and were selected via randomization method. Newborns were divided into four groups; Breastfeeding group (n=48), Vibration group (n=48), Breastfeeding+Vibration group (n=48), and Control group (n=48).
Data were collected using the Infant-family Information Form and NIPS-Neonatal Infant Pain Scale. Data collection All blood sampling was performed in a quiet nursery room between 09:00 AM and 11:00 AM, 1-2 hours after breastfeeding, the normal time when infants undergo heel stick for routine blood collection for metabolic screening. Blood collection was performed in a standardized manner by the same nurse who has a minimum of 5 years' experience in the performance heel stick and had no conflict of interest. A pediatrician made the clinical decision for heel stick.
Before the procedure, the newborns were kept in a quiet room far away from the cries of other babies. The infants' diapers were changed before procedure. For the heel stick procedure, the antiseptic solution (70% alcohol), heel stick method, heel region for sampling (the outer right side of the ball), needle (21-G needle), and environmental factors such as heat, light, and noise were all standardized. The whole procedure was video-recorded until three minutes after the procedure.
At the beginning of the study, the parents of the newborns were informed about the aim and content of the research, and parental approval was obtained. Neonatal and family demographics were collected using self-report information forms, which included medical history, mother's gestational age, neonatal age, sex, birth weight, duration of sampling, total crying time, processing time, and the time from the start of the first cry to the first crying during the process.
All blood sampling in the study was performed for clinical purposes, such as newborn metabolic screening tests, which were taken on the second to third days following birth. The standard protocol for blood sampling involved swabbing the heel with a small gauze pad with disinfectant, lancing the heel, and then gently squeezing the heel intermittently until the amount of blood required for clinical use was collected.
All procedures performed in the experimental and control groups were video recorded by the researcher from the beginning of the procedure. After the procedure the newborns' pain levels and crying duration were evaluated using the video recordings. Assessment of pain was conducted independently by the investigator and the nurse using NIPS. At the same time, the newborns' total procedural crying time, the duration of the procedure, and the first calming time were recorded. The total crying time of the newborns was measured from the start of crying due to heel stick to the complete cessation of crying. The time of the procedure was measured from the beginning to the end of the heel stick procedure. The calming time was measured from the time of the first cry to the first calming time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Parallel Assignment Prospective, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding Group | Experimental | Behavioral: BreastfeedingBreastfeeding was applied to the infants in this group before and during the heel lance procedure. |
| Vibration Group | Experimental | Device: VibrationVibration was applied to the infants in this group before and during the heel lance procedure. |
| Breastfeeding+Vibration Group | Experimental | Other: Breastfeeding+VibrationBreastfeeding+Vibration was applied to the infants in this group before and during the heel lance procedure. |
| Control Group | No intervention | –In this group, infants received routine heel blood collection procedure. |
Who may qualify
- Ages
- 2 to 4 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Parents who volunteered and gave consent to participate in the research
- Full term neonates (38-42 weeks of gestation)
- Underwent heel stick blood drawing for routine metabolic screening,
- Aged 2 to 4 days
- Passed the hearing screening
Key exclusion criteria (2 listed)
- Parents with any mental problems
- Infants with any chronic disease and congenital anomalies.
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 |
|---|---|---|
| BreastfeedingThe routine practice of the Breastfeeding Group is to place the infants in their mother's arms and start breastfeeding 1 minute before the procedure. Then, the nurse will take the heel blood. | Behavioural | Breastfeeding Group |
| VibrationThe vibration device was placed on the infant's left extremity in the mid/lateral region just below the knee where the sural nerve passes. The device was secured to the extremity with a gauze bandage. The infants in the Vibration Group will be placed in their mother's arms and vibration will be applied 30 seconds before the routine application, and vibration will be applied during the 10-second waiting phase while the nurse performs the heel prick blood collection procedure. | Device | Vibration Group |
| Breastfeeding+VibrationThe vibration device was placed on the infant's left extremity in the mid/lateral region just below the knee where the sural nerve passes. The device was secured to the extremity with a gauze bandage. The routine practice for the Breastfeeding+Vibration Group babies will be started by holding them in their mother's arms and breastfeeding will be started 1 minute before the application. At the same time, vibration will be applied 30 seconds before the application and vibration will be applied in a 10-second waiting phase while the nurse performs the heel prick procedure. | Other | Breastfeeding+Vibration Group |
Primary outcome
NIPS (Neonatal Infant Pain Scale)
Time frame: average 5 minutes) during the heel blood collection procedures (1 minute before the heel lance procedure (T-1 minute), during the procedure (T+0 second), and 2 minutes (T+2 minutes)]
It was developed by Lawrence et al. in 1993 to evaluate interventional pain in newborns (Lawrence et al, 1993). Its Turkish adaptation was made by Akdovan and Yıldırım in 1999. NIPS is an assessment tool that focuses on six behavioral responses of newborns: facial expressions, crying, breathing, arm movements, leg movements, and arousal. A score between 0 and 7 is obtained from the scale, and as the score obtained from the scale increases, the pain of newborns also increases. In the Turkish adaptation study of the scale, the Cronbach's alpha value was calculated as 0.83 before the procedure, 0.83 during the procedure and 0.86 after the procedure.
3 secondary outcomes
Crying times
Time frame: [Time Frame: during the heel blood collection procedures (average 5 minutes)]
Processing time
Time frame: [Time Frame: during the heel blood collection procedures (average 5 minutes)]
The time to first calming
Time frame: [Time Frame: Procedure (The calming time was measured from the time of the first cry to the first calming time.) (average 5 minutes)]
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 9 Jul 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this study, after deidentification, will be shared with researchers who provide a methodologically sound proposal.
Related trials for Newborn
Active, not recruitingPhase 2
Pilot Study of Reduced-Intensity Hematopoietic Stem Cell Transplant of DOCK8 Deficiency
DOCK8 Deficiency
Recruiting
Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Meconium Exposure
Neonatal Respiratory Distress Related Conditions, Meconium
RecruitingObservational study
Natural History Evaluation of Charcot Marie Tooth Disease (CMT) Types CMT1B, CMT2A, CMT4A, CMT4C, and Others
Charcot Marie Tooth Disease
RecruitingObservational study
Blood Sampling for Research Related to Sickle Cell Disease
Sickle Cell Trait, Sickle Cell Disease
Recruiting
The Effect of Probiotics in Infantile Colic
Infantile Colic
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.
Selda Ateş Beşirik principal investigator
Burdur Mehmet Akif Ersoy 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 Breastfeeding, Vibration and Breastfeeding+Vibration in people with Newborn and Pain Management, run by Burdur Mehmet Akif Ersoy 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 7 inclusion and 2 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 9 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?
NIPS (Neonatal Infant Pain Scale) (time frame: average 5 minutes) during the heel blood collection procedures (1 minute before the heel lance procedure (T-1 minute), during the procedure (T+0 second), and 2 minutes (T+2 minutes)]). 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 9 Jul 2025.