PainNCT06813183
The Effect of Palmar Grip Reflex Stimulation on Pain During Heel Blood Collection in Newborns
A study testing The palmar grasping reflex in people with Pain, run by Erzincan Binali Yildirim Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Pain is defined by the International Association for the Study of Pain (IASP) as "an unpleasant sensory and emotional experience associated with or defined in terms of actual or potential tissue damage" . Since 1980, the newborn may encounter around 300 painful procedures with hospitalization. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Pain
- What is being tested?
- The palmar grasping reflex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2024to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Newborns who need oxygen support,
- Are fed with an orogastric tube,
- Those whose first attempt at heel blood collection was unsuccessful,
- Those who need parenteral nutrition,
- Those receiving analgesic treatment,
- Those with physical, metabolic and genetic diseases,
Show all 9Show fewer
- Those who have undergone a surgical procedure,
- Those with nerve damage or deformity in the extremity from which the heel blood will be collected,
- Newborns whose parents (mother or father) do not give verbal and written consent and wish to withdraw from the study will not be included.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erzincan Binali Yıldırım University
Merkez, Erzincan
About this study
Official title: Erzi̇ncan Binali Yildirim University
Pain is defined by the International Association for the Study of Pain (IASP) as "an unpleasant sensory and emotional experience associated with or defined in terms of actual or potential tissue damage" . Since 1980, the newborn may encounter around 300 painful procedures with hospitalization. Before 1980, there was a misperception that newborns do not feel pain. Later research revealed that newborns feel pain and are sensitive to painful stimuli. Accurate assessment of pain in term or preterm newborns hospitalized in the Neonatal Intensive Care Unit (NICU) is of great importance in terms of mortality and morbidity due to the high prevalence of painful procedures, including daily procedural pain and postoperative pain.
An infant hospitalized in the neonatal intensive care unit for diagnosis and treatment purposes undergoes many interventions that cause pain and stress (intubation, arterial/venous catheter insertion, aspiration, chest tube, urinary catheter, nasogastric catheter insertion, dressing, plaster change, chest physiotherapy). Although newborns do not express pain verbally, they reveal pain with their reactions. Autonomic reactions in the body are understood from heart rate, respiration, and oxygen saturation. In addition to these, there are hormonal reactions. Behavioral responses include sleeping, waking up, crying, body movements and facial expressions.
Read more
Excessive, prolonged painful interventions in the newborn can have significant effects on adverse physiological, neuro-sensory, cognitive and behavioral health outcomes that can be life-threatening and have long-term effects on all major organ systems . It is stated that the neurodevelopment of infants exposed to repetitive painful interventional procedures may be negatively affected and may lead to problems such as sleep problems, attention deficit and learning disorders in later childhood. Therefore, it is important to reduce the stress caused by illness and hospitalization in newborns and minimize this traumatic effect.
Environmental (restricted noise and light) measures, sucrose solutions, kangaroo care, breast milk and breastfeeding, non-nutritive sucking, swaddling, massage, music, maternal (breast milk) and aromatic scents, positioning (developmental position), rocking and individualized developmental care have been shown to be effective in soothing infants during painful/stressful procedures.
The palmar grasping reflex is a component of attachment behavior that is considered therapeutic for both the infant and the caregiver. The grasping reflex is one of the most important primitive reflexes and is defined as an involuntary grasping and grasping movement in newborns. The grasping reflex occurs in both hands (palmar) and feet (plantar). The palmar grasp reflex is an involuntary flexion-adduction movement involving the hands and fingers. Holding and grasping the hand of the nurse, mother or caregiver can have a calming effect on the baby.
The Newborn Metabolic and Endocrine Disease Screening Program is implemented all over the world. The aim of the newborn screening program is to provide early diagnosis of congenital metabolic and endocrine disorders that may cause long-term sequelae or even result in death if left untreated. The metabolic diseases included in 13 newborn screening programs in Turkey are phenylketonuria (PKU), congenital hypothyroidism, biotinidase deficiency, cystic fibrosis (CF), congenital adrenal hyperplasia and spinal muscular atrophy (SMA).
Blood sample for newborn screening should ideally be taken at 36-72 hours. The application is performed by placing a few drops of blood taken from the heel of the baby's foot on Guthrie paper. Capillary blood is more easily collected and stored compared to whole blood or plasma samples. Therefore, capillary blood sample taken from the heel is preferred in the screening program. The medial (inner) or lateral (outer) parts of the plantar (sole) surfaces of the infant's heel should be used for blood collection. The heel of the baby's foot should be cleaned with 70% alcohol. Before piercing the skin, the alcohol should be allowed to dry so that the alcohol and blood do not mix. Mixing of blood and alcohol causes hemolysis of red blood cells and leads to erroneous results.
Although there are many studies on reducing and controlling the pain that newborns are exposed to in neonatal intensive care, the number of studies on the use of palmar grasping reflex during painful interventions is limited.
- Conditions
- Pain
- Being tested
- The palmar grasping reflex
- Keywords
- palmar grasping reflex, newborn, nurse
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The palmar grasping reflexOther
Also called Experimental Procedure
In the experimental group, the baby is monitored under a radiant heater before the procedure. After the infant's initial physiologic parameters and NIPS are recorded, the palmar grasp reflex is stimulated just before the procedure begins. The palmar grasp reflex can be stimulated by moving an object distally across the palm of the hand. In newborns, the right hand is more dominant than the left hand in the palmar grasp reflex ( Fagard et al., 2017). The researcher will stimulate the palmar grasp reflex by moving the index finger distally along the palm of the infant's right hand. The reflex stimulation will be continued until the end of the 5th minute.
Physiologic parameters will be scored by the investigator and a second nurse with at least 5 years of experience in neonatal intensive care and recorded on the follow-up form by scoring the pain levels 1 minute before (0 min), during, 2 and 5 min after the heel pricking procedure in the neonates in the NIPS intervention groups via the be
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | The heel prick attempt was planned one hour after the babies were breastfed (since the painful procedure may cause crying, doing it immediately after feeding may cause vomiting with crying).
The infant included in the study in each group was placed in a resting period in his/her bed, undisturbed until 30 minutes before the start of the test (Dinç 2023). The heel prick procedure will be performed under radiant heater in the neonatal intensive care unit. The baby is monitored before starting the procedure under the radiant heater. Blood collection will be performed in accordance with the routine heel prick procedure.
Physiologic parameters and pain levels 1 minute before (0 min), during, 2 and 5 min after the heel prick procedure in newborns in the NIPS control groups will be scored by the researcher and a second nurse with at least 5 years of experience in neonatal intensive care and recorded on the follow-up form (Çatal 2023). Receives: Other: The palmar grasping reflex |
| Experimental group | Experimental | In the experimental group, the baby is monitored under a radiant heater before the procedure. After the infant's initial physiologic parameters and NIPS are recorded, the palmar grasp reflex is stimulated just before the procedure begins. The palmar grasp reflex can be stimulated by moving an object distally across the palm of the hand. In newborns, the right hand is more dominant than the left hand in the palmar grasp reflex ( Fagard et al., 2017). The researcher will stimulate the palmar grasp reflex by moving the index finger distally along the palm of the infant's right hand. The reflex stimulation will be continued until the end of the 5th minute. Receives: Other: The palmar grasping reflex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Infant Pain Scale (NIPS)
The Neonatal Infant Pain Scale (NIPS) is a scale that includes behavioral parameters used to assess the pain of premature and term newborns. The Neonatal Infant Pain Scale includes five behavioral parameters including facial expression, crying, arm and leg movements, and alertness, and a physiological parameter measurement in which respiration is evaluated. In the evaluation of the scale, the score varies between 0-7. In the scoring of the scale, 0-2 points indicate no pain/mild pain, 3-4 points indicate mild pain/moderate pain and >4 points indicate severe pain. Cronbach's alpha coefficient of the scale was 0.95 before the procedure, 0.87 during the procedure and 0.88 after the procedure (Lawrence, 1993). Turkish validity and reliability of the scale was performed by Akdovan et al. (1999).
Measured: values 1 minute before, during, 2 and 5 minutes after the procedure during the interventions
Secondary outcomes (3)
Newborn' s SpO2
This form was developed by the researchers in line with the literature in order to record information such as physiologic parameters of newborns (SpO2, heart rate), crying time and procedure time (Çatal 2023).
Measured: values 1 minute before, during, 2 and 5 minutes after the procedure during the interventions
Newborn' s hearth rate
This form was developed by the researchers in line with the literature in order to record
Measured: values 1 minute before, during, 2 and 5 minutes after the procedure during the interventions
Newborn' s crying time
This form was developed by the researchers in line with the literature in order to record
Measured: values 1 minute before, during, 2 and 5 minutes after the procedure during the interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start15 Aug 2024
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Sep 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erzincan Binali Yildirim Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Necla Kasımoğlu, Erzincan Binali Yildirim Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813183
- Sponsor's protocol ID
- 123456
- Status last verified
- Feb 2025
- First submitted
- 28 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erzi̇ncan Binali Yildirim University
- ClinicalTrials.gov ID
- NCT06813183
- Acronym / sponsor ID
- 123456
- Conditions
- Pain
- Keywords
- palmar grasping reflex, newborn, nurse
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Erzincan Binali Yildirim UniversitesiUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Sep 2025 (estimated)
- First posted
- 6 Feb 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 is defined by the International Association for the Study of Pain (IASP) as "an unpleasant sensory and emotional experience associated with or defined in terms of actual or potential tissue damage" . Since 1980, the newborn may encounter around 300 painful procedures with hospitalization. Before 1980, there was a misperception that newborns do not feel pain. Later research revealed that newborns feel pain and are sensitive to painful stimuli. Accurate assessment of pain in term or preterm newborns hospitalized in the Neonatal Intensive Care Unit (NICU) is of great importance in terms of mortality and morbidity due to the high prevalence of painful procedures, including daily procedural pain and postoperative pain.
An infant hospitalized in the neonatal intensive care unit for diagnosis and treatment purposes undergoes many interventions that cause pain and stress (intubation, arterial/venous catheter insertion, aspiration, chest tube, urinary catheter, nasogastric catheter insertion, dressing, plaster change, chest physiotherapy). Although newborns do not express pain verbally, they reveal pain with their reactions. Autonomic reactions in the body are understood from heart rate, respiration, and oxygen saturation. In addition to these, there are hormonal reactions. Behavioral responses include sleeping, waking up, crying, body movements and facial expressions.
Excessive, prolonged painful interventions in the newborn can have significant effects on adverse physiological, neuro-sensory, cognitive and behavioral health outcomes that can be life-threatening and have long-term effects on all major organ systems . It is stated that the neurodevelopment of infants exposed to repetitive painful interventional procedures may be negatively affected and may lead to problems such as sleep problems, attention deficit and learning disorders in later childhood. Therefore, it is important to reduce the stress caused by illness and hospitalization in newborns and minimize this traumatic effect.
Environmental (restricted noise and light) measures, sucrose solutions, kangaroo care, breast milk and breastfeeding, non-nutritive sucking, swaddling, massage, music, maternal (breast milk) and aromatic scents, positioning (developmental position), rocking and individualized developmental care have been shown to be effective in soothing infants during painful/stressful procedures.
The palmar grasping reflex is a component of attachment behavior that is considered therapeutic for both the infant and the caregiver. The grasping reflex is one of the most important primitive reflexes and is defined as an involuntary grasping and grasping movement in newborns. The grasping reflex occurs in both hands (palmar) and feet (plantar). The palmar grasp reflex is an involuntary flexion-adduction movement involving the hands and fingers. Holding and grasping the hand of the nurse, mother or caregiver can have a calming effect on the baby.
The Newborn Metabolic and Endocrine Disease Screening Program is implemented all over the world. The aim of the newborn screening program is to provide early diagnosis of congenital metabolic and endocrine disorders that may cause long-term sequelae or even result in death if left untreated. The metabolic diseases included in 13 newborn screening programs in Turkey are phenylketonuria (PKU), congenital hypothyroidism, biotinidase deficiency, cystic fibrosis (CF), congenital adrenal hyperplasia and spinal muscular atrophy (SMA).
Blood sample for newborn screening should ideally be taken at 36-72 hours. The application is performed by placing a few drops of blood taken from the heel of the baby's foot on Guthrie paper. Capillary blood is more easily collected and stored compared to whole blood or plasma samples. Therefore, capillary blood sample taken from the heel is preferred in the screening program. The medial (inner) or lateral (outer) parts of the plantar (sole) surfaces of the infant's heel should be used for blood collection. The heel of the baby's foot should be cleaned with 70% alcohol. Before piercing the skin, the alcohol should be allowed to dry so that the alcohol and blood do not mix. Mixing of blood and alcohol causes hemolysis of red blood cells and leads to erroneous results.
Although there are many studies on reducing and controlling the pain that newborns are exposed to in neonatal intensive care, the number of studies on the use of palmar grasping reflex during painful interventions is limited.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Other: The palmar grasping reflexThe heel prick attempt was planned one hour after the babies were breastfed (since the painful procedure may cause crying, doing it immediately after feeding may cause vomiting with crying). The infant included in the study in each group was placed in a resting period in his/her bed, undisturbed until 30 minutes before the start of the test (Dinç 2023). The heel prick procedure will be performed under radiant heater in the neonatal intensive care unit. The baby is monitored before starting the procedure under the radiant heater. Blood collection will be performed in accordance with the routine heel prick procedure. Physiologic parameters and pain levels 1 minute before (0 min), during, 2 and 5 min after the heel prick procedure in newborns in the NIPS control groups will be scored by the researcher and a second nurse with at least 5 years of experience in neonatal intensive care and recorded on the follow-up form (Çatal 2023). |
| Experimental group | Experimental | Other: The palmar grasping reflexIn the experimental group, the baby is monitored under a radiant heater before the procedure. After the infant's initial physiologic parameters and NIPS are recorded, the palmar grasp reflex is stimulated just before the procedure begins. The palmar grasp reflex can be stimulated by moving an object distally across the palm of the hand. In newborns, the right hand is more dominant than the left hand in the palmar grasp reflex ( Fagard et al., 2017). The researcher will stimulate the palmar grasp reflex by moving the index finger distally along the palm of the infant's right hand. The reflex stimulation will be continued until the end of the 5th minute. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Newborns who need oxygen support,
- Are fed with an orogastric tube,
- Those whose first attempt at heel blood collection was unsuccessful,
- Those who need parenteral nutrition,
- Those receiving analgesic treatment,
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 |
|---|---|---|
| The palmar grasping reflexAlso: Experimental ProcedureIn the experimental group, the baby is monitored under a radiant heater before the procedure. After the infant's initial physiologic parameters and NIPS are recorded, the palmar grasp reflex is stimulated just before the procedure begins. The palmar grasp reflex can be stimulated by moving an object distally across the palm of the hand. In newborns, the right hand is more dominant than the left hand in the palmar grasp reflex ( Fagard et al., 2017). The researcher will stimulate the palmar grasp reflex by moving the index finger distally along the palm of the infant's right hand. The reflex stimulation will be continued until the end of the 5th minute. Physiologic parameters will be scored by the investigator and a second nurse with at least 5 years of experience in neonatal intensive care and recorded on the follow-up form by scoring the pain levels 1 minute before (0 min), during, 2 and 5 min after the heel pricking procedure in the neonates in the NIPS intervention groups via the be | Other | Control Group, Experimental group |
Primary outcome
Neonatal Infant Pain Scale (NIPS)
Time frame: values 1 minute before, during, 2 and 5 minutes after the procedure during the interventions
The Neonatal Infant Pain Scale (NIPS) is a scale that includes behavioral parameters used to assess the pain of premature and term newborns. The Neonatal Infant Pain Scale includes five behavioral parameters including facial expression, crying, arm and leg movements, and alertness, and a physiological parameter measurement in which respiration is evaluated. In the evaluation of the scale, the score varies between 0-7. In the scoring of the scale, 0-2 points indicate no pain/mild pain, 3-4 points indicate mild pain/moderate pain and >4 points indicate severe pain. Cronbach's alpha coefficient of the scale was 0.95 before the procedure, 0.87 during the procedure and 0.88 after the procedure (Lawrence, 1993). Turkish validity and reliability of the scale was performed by Akdovan et al. (1999).
3 secondary outcomes
Newborn' s SpO2
Time frame: values 1 minute before, during, 2 and 5 minutes after the procedure during the interventions
Newborn' s hearth rate
Time frame: values 1 minute before, during, 2 and 5 minutes after the procedure during the interventions
Newborn' s crying time
Time frame: values 1 minute before, during, 2 and 5 minutes after the procedure during the interventions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The palmar grasping reflex in people with Pain, run by Erzincan Binali Yildirim Universitesi 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 0 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 6 Feb 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?
This study is still under way. Results are not available in the source record yet.
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?
Neonatal Infant Pain Scale (NIPS) (time frame: values 1 minute before, during, 2 and 5 minutes after the procedure during the interventions). 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 6 Feb 2025.