Pain, AcuteNCT06350071
Effect of Kangaroo Care and Swaddling Methods on Pain Level and Crying Time During Heel Blood Collection
A study testing Kangaroo Care and Swaddling in people with Pain, Acute and Newborns, 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 kangaroo care and swaddling methods on pain levels and crying times by newborns during heel blood collection. Read more about this study
- Who is it for?
- Ages 1 day to 4 daysHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Newborns, Crying
- What is being tested?
- Kangaroo Care and Swaddling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jun 2023to 14 Mar 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 day 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 1 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 Bucak State Hospital
Burdur, Bucak, 15030
About this study
Official title: The Effect of Kangaroo Care and Swaddling Methods on Pain Level and Crying Time During Heel Blood Collection in Newborns: A Randomized Controlled Study
This prospective study is planned as a randomized controlled study with the purpose of determining the effect of kangaroo care and swaddling methods on pain levels and crying times by newborns during heel blood collection.
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 kangaroo care and swaddling methods applied during heel blood collection on the pain levels and crying times in newborns will be examined.
Sample of the study consisted of a total of 120 newborns who met the sample selection criteria and were selected via randomization method. Newborns were divided into three groups; kangaroo care group (n=40), swaddling group (n=40), and control group (n=40).
Data were collected using the Infant-family Information Form, NIPS - Neonatal Infant Pain Scale, and Crying Follow-up Form.
- Conditions
- Pain, Acute, Newborns, Crying
- Being tested
- Kangaroo Care, Swaddling
- Keywords
- Newborn, Pain, Crying time, Kangaroo care, Swaddling, Heel stick
- Medical subject headings
- Acute Pain, Crying, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo CareBehavioural
Kangaroo care will be applied so that the infant and mother will have skin-to-skin contact, and heel blood will be taken.
SwaddlingBehavioural
Heel blood will be taken while the infant was swaddled in the maternal holding.
| Study group | Role | What they receive |
|---|---|---|
| Kangaroo Care Group | Experimental | Kangaroo care will be applied so that the infant and mother will have skin-to-skin contact, and heel blood will be taken. Receives: Behavioral: Kangaroo Care |
| Swaddling Group | Experimental | Heel blood will be taken while the infant was swaddled in the maternal holding. Receives: Behavioral: Swaddling |
| 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 to evaluate interventional pain in newborns. Its Turkish adaptation was 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: during the heel blood collection procedures
Secondary outcomes (2)
Crying times
Duration of crying were recorded.
Measured: during the heel blood collection procedures
Processing time
Duration of heel blood collection procedure were recorded.
Measured: during the heel blood collection procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start19 Jun 2023
- Primary completion15 Dec 2024
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 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, PhD., Principal investigator, Burdur Mehmet Akif Ersoy UniversityEmine Geçkil, Professor, Study director, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350071
- Sponsor's protocol ID
- 2023/06
- Status last verified
- Jul 2025
- First submitted
- 1 Apr 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
- The Effect of Kangaroo Care and Swaddling Methods on Pain Level and Crying Time During Heel Blood Collection in Newborns: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06350071
- Acronym / sponsor ID
- 2023/06
- Conditions
- Pain, Acute, Newborns, Crying
- Keywords
- Newborn, Pain, Crying time, Kangaroo care, Swaddling, Heel stick
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Burdur Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 5 Apr 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 kangaroo care and swaddling methods on pain levels and crying times by newborns during heel blood collection.
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 kangaroo care and swaddling methods applied during heel blood collection on the pain levels and crying times in newborns will be examined.
Sample of the study consisted of a total of 120 newborns who met the sample selection criteria and were selected via randomization method. Newborns were divided into three groups; kangaroo care group (n=40), swaddling group (n=40), and control group (n=40).
Data were collected using the Infant-family Information Form, NIPS - Neonatal Infant Pain Scale, and Crying Follow-up Form.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Kangaroo Care Group | Experimental | Behavioral: Kangaroo CareKangaroo care will be applied so that the infant and mother will have skin-to-skin contact, and heel blood will be taken. |
| Swaddling Group | Experimental | Behavioral: SwaddlingHeel blood will be taken while the infant was swaddled in the maternal holding. |
| Control Group | No intervention | –In this group, infants received routine heel blood collection procedure. |
Who may qualify
- Ages
- 1 day 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 1 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 |
|---|---|---|
| Kangaroo CareKangaroo care will be applied so that the infant and mother will have skin-to-skin contact, and heel blood will be taken. | Behavioural | Kangaroo Care Group |
| SwaddlingHeel blood will be taken while the infant was swaddled in the maternal holding. | Behavioural | Swaddling Group |
Primary outcome
NIPS (Neonatal Infant Pain Scale)
Time frame: during the heel blood collection procedures
It was developed to evaluate interventional pain in newborns. Its Turkish adaptation was 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.
2 secondary outcomes
Crying times
Time frame: during the heel blood collection procedures
Processing time
Time frame: during the heel blood collection procedures
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.
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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.
Selda Ateş Beşirik, PhD. principal investigator
Burdur Mehmet Akif Ersoy University
Emine Geçkil, Professor study director
Necmettin Erbakan 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 Kangaroo Care and Swaddling in people with Pain, Acute and Newborns, 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: during the heel blood collection procedures). 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.