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AzTrials

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).

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 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
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

Other trials in Turkey (Türkiye)

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.

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 groups in NCT06741670
Study groupRoleWhat they receive
Breastfeeding GroupExperimentalBreastfeeding was applied to the infants in this group before and during the heel lance procedure.
Receives: Behavioral: Breastfeeding
Vibration GroupExperimentalVibration was applied to the infants in this group before and during the heel lance procedure.
Receives: Device: Vibration
Breastfeeding+Vibration GroupExperimentalBreastfeeding+Vibration was applied to the infants in this group before and during the heel lance procedure.
Receives: Other: Breastfeeding+Vibration
Control GroupNo interventionIn 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.

  1. 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)
  1. Crying times

    Duration of crying were recorded.

    Measured: [Time Frame: during the heel blood collection procedures (average 5 minutes)]

  2. Processing time

    Duration of heel blood collection procedure were recorded.

    Measured: [Time Frame: during the heel blood collection procedures (average 5 minutes)]

  3. 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.

  1. First posted19 Dec 2024
  2. Study start2 Sep 2024
  3. Primary completion29 May 2025
  4. Study completion4 Jul 2025

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
Model description
Parallel Assignment Prospective, randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
192 participants (actual)
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.

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.

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