PainNCT06567093
Effect of Leg and Heel Massage on Pain During Heel Blood Collection Newborns
A study testing Baby Foot and Leg Massage in people with Pain and Infant ALL, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to evaluate the effect of leg and heel massage on newborns, the pain experienced during heel blood collection, and the effects on physiological parameters. H1: Newborn Infants Pain Scale scores are lower in leg and heel massage group than control group. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Pain, Infant ALL
- What is being tested?
- Baby Foot and Leg Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2024to 15 Jun 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 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestational age is 38-41 weeks,
- The birth weight of the newborn is >2500 g
- Vital signs should be stable before the procedure,
- Postanatal age is between 2-28 days,
- There are no contraindications for the application of massage
- Delivery of the newborn to the mother after birth
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- Permission of the parents of the newborn participating in the research
- Fasting period less than 3 hours/fed 30 minutes before
- A newborn who does not cry before heel blood is taken
Who cannot join
- Newborns who need respiratory support,
- Newborns with any neurological disorders (seizures)
- Newborns using opioids or babies born to mothers using opioids
- Newborns taking muscle relaxants, sedatives, analgesics
- Babies with major congenital anomalies
- Babies with an APGAR score of less than 7 in 5 minutes,
Show all 11Show fewer
- Newborns who have undergone any surgery
- Newborns with birth trauma (especially rapid births)
- There are situations that may prevent communication with parents (e.g. language problems).
- problem)
- Newborns planned to be transferred to another hospital
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bartın University
Bartın, Province, 74100
Aylin Kurt, PhD, +905382087211, aylinkurt67@gmail.com
About this study
Official title: Effect of Leg and Heel Massage on Pain Experienced During Heel Blood Collection and Physiological Parameters in Newborns: Randomized Controlled Study
This study was planned to evaluate the effect of leg and heel massage on newborns, the pain experienced during heel blood collection, and the effects on physiological parameters.
H1: Newborn Infants Pain Scale scores are lower in leg and heel massage group than control group.
H2: Heart rates are lower in leg and heel massage group than control group. H3: Oxygen saturation levels are higher in leg and heel massage group than control group.
Read the detailed description
In this study, there will be two groups as the intervention (who will receive leg and heel massage) and the control group (who will receive routine care). A power analysis was performed based on the number of children in both groups, based on another study using the scales to be used in the research. According to the calculations made in the G-Power 3.1 Demo package program, when the effect size was accepted as 0.8, it was seen that at least 30 cases in each group would be sufficient for 80% power. Infants who meet the research criteria will be randomly assigned to the intervention and control groups via http://www.randomize.org/ by assigning a number to the order of arrival at the hospital. The heel blood collection will be applied to both the intervention and control groups. For children in the massage group, the massage will be applied to both legs and heels of the baby. Immediately before the procedure, each leg and heel will be massaged for three minutes. The control group will receive heel blood collection with routine care. A researcher and a nurse were employed for the heel blood collection both for the intervention and control groups. A pediatric nurse performed the heel blood collection for all infants and the other researcher helped the children to assess their pain, heart rates and Oxygen saturation. Measurements 5 minutes before the heel prick procedure, during the procedure (1st minute) and 5 minutes after the heel prick application. The heel blood collection will be performed by the same nurse both in the intervention and control groups.
- Conditions
- Pain, Infant ALL
- Being tested
- Baby Foot and Leg Massage
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baby Foot and Leg MassageOther
Baby Foot Massage stages
- The baby is placed on his back, either on the bed or on the couch.
- One of the baby's feet is lifted into the air by grasping the back of the ankle.
- Start stroking with circular movements, starting from the heel and moving up to the toes. Stroking should be done with the thumb.
- Here, it might be good to get between the toes.
- The same procedure is applied to the other foot.
- Massage is continued until it is noticed that the baby calms down.
Baby Leg Massage stages
- Start by lifting the leg to be massaged.
- Here, the palms of both hands are used. The baby's leg is placed between both hands and the leg is stroked by moving the palms in opposite directions. This movement is continued from above the ankle to the hip.
- The same procedure is applied to the other leg.
- Massage is continued until the baby calms down.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | All registered participants in the intervention group, will receive the leg and heel massage before the the heel blood collection. Receives: Other: Baby Foot and Leg Massage |
| Control | No intervention | All registered participants in the intervention group, will receive the routine care before the leg and heel massage before the the heel blood collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of the mean score of the "Newborn Infants Pain Scale" between intervention and control groups
Pain assessment will be made with the "Newborn Infants Pain Scale". The "Newborn Infants Pain Scale" will be measured again during the heel prick procedure (at the 1st minute) and 5 minutes after the heel prick. At the end of the study, the change of the mean score of "Newborn Infants Pain Scale" between intervention and control groups will be examined. Data will be analyzed using Statistical Package for the Social Sciences package program.
Measured: 9 months
Secondary outcomes (2)
Difference of the mean score of the heart rate peak between intervention and control groups
Heart rate peak, which is a physiological parameter, will be evaluated. During the heel prick procedure (at the 1st minute) and 5 minutes after the heel prick application, the heart rate will be measured again. At the end of the study, the change of the mean score of "peak heart rate" between intervention and control groups will be examined. Data will be analyzed using Statistical Package for the Social Sciences package program.
Measured: 9 months
Difference of the mean score of the oxygen saturation between intervention and control groups
Oxygen saturation value, which is a physiological parameter, will be evaluated. Oxygen saturation will be measured again during the heel prick procedure (at the 1st minute) and 5 minutes after the heel prick application. At the end of the study, the change of the mean score of "oxygen saturation" between intervention and control groups will be examined. Data will be analyzed using Statistical Package for the Social Sciences package program.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start15 Aug 2024
- Primary completion15 May 2025 (estimated)
- Study completion15 Jun 2025 (estimated)
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bartın Unıversity
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aylin Kurt, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567093
- Sponsor's protocol ID
- 2024-SBB-0076
- Status last verified
- Aug 2024
- First submitted
- 20 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Leg and Heel Massage on Pain Experienced During Heel Blood Collection and Physiological Parameters in Newborns: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06567093
- Acronym / sponsor ID
- 2024-SBB-0076
- Conditions
- Pain, Infant ALL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bartın UnıversityUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 22 Aug 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 study was planned to evaluate the effect of leg and heel massage on newborns, the pain experienced during heel blood collection, and the effects on physiological parameters.
H1: Newborn Infants Pain Scale scores are lower in leg and heel massage group than control group.
H2: Heart rates are lower in leg and heel massage group than control group. H3: Oxygen saturation levels are higher in leg and heel massage group than control group.
Detailed description
In this study, there will be two groups as the intervention (who will receive leg and heel massage) and the control group (who will receive routine care). A power analysis was performed based on the number of children in both groups, based on another study using the scales to be used in the research. According to the calculations made in the G-Power 3.1 Demo package program, when the effect size was accepted as 0.8, it was seen that at least 30 cases in each group would be sufficient for 80% power. Infants who meet the research criteria will be randomly assigned to the intervention and control groups via http://www.randomize.org/ by assigning a number to the order of arrival at the hospital. The heel blood collection will be applied to both the intervention and control groups. For children in the massage group, the massage will be applied to both legs and heels of the baby. Immediately before the procedure, each leg and heel will be massaged for three minutes. The control group will receive heel blood collection with routine care. A researcher and a nurse were employed for the heel blood collection both for the intervention and control groups. A pediatric nurse performed the heel blood collection for all infants and the other researcher helped the children to assess their pain, heart rates and Oxygen saturation. Measurements 5 minutes before the heel prick procedure, during the procedure (1st minute) and 5 minutes after the heel prick application. The heel blood collection will be performed by the same nurse both in the intervention and control groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Baby Foot and Leg MassageAll registered participants in the intervention group, will receive the leg and heel massage before the the heel blood collection. |
| Control | No intervention | –All registered participants in the intervention group, will receive the routine care before the leg and heel massage before the the heel blood collection. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Gestational age is 38-41 weeks,
- The birth weight of the newborn is >2500 g
- Vital signs should be stable before the procedure,
- Postanatal age is between 2-28 days,
- There are no contraindications for the application of massage
Key exclusion criteria (11 listed)
- Newborns who need respiratory support,
- Newborns with any neurological disorders (seizures)
- Newborns using opioids or babies born to mothers using opioids
- Newborns taking muscle relaxants, sedatives, analgesics
- Babies with major 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 |
|---|---|---|
| Baby Foot and Leg MassageBaby Foot Massage stages * The baby is placed on his back, either on the bed or on the couch. * One of the baby's feet is lifted into the air by grasping the back of the ankle. * Start stroking with circular movements, starting from the heel and moving up to the toes. Stroking should be done with the thumb. * Here, it might be good to get between the toes. * The same procedure is applied to the other foot. * Massage is continued until it is noticed that the baby calms down. Baby Leg Massage stages * Start by lifting the leg to be massaged. * Here, the palms of both hands are used. The baby's leg is placed between both hands and the leg is stroked by moving the palms in opposite directions. This movement is continued from above the ankle to the hip. * The same procedure is applied to the other leg. * Massage is continued until the baby calms down. | Other | Experimental |
Primary outcome
Difference of the mean score of the "Newborn Infants Pain Scale" between intervention and control groups
Time frame: 9 months
Pain assessment will be made with the "Newborn Infants Pain Scale". The "Newborn Infants Pain Scale" will be measured again during the heel prick procedure (at the 1st minute) and 5 minutes after the heel prick. At the end of the study, the change of the mean score of "Newborn Infants Pain Scale" between intervention and control groups will be examined. Data will be analyzed using Statistical Package for the Social Sciences package program.
2 secondary outcomes
Difference of the mean score of the heart rate peak between intervention and control groups
Time frame: 9 months
Difference of the mean score of the oxygen saturation between intervention and control groups
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby Foot and Leg Massage in people with Pain and Infant ALL, run by Bartın Unıversity 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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 22 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aylin Kurt, PhD (+905382087211, aylinkurt67@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of the mean score of the "Newborn Infants Pain Scale" between intervention and control groups (time frame: 9 months). 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 22 Aug 2024.