Infant DevelopmentNCT06513897
The Effects of Acupressure and Paternal Holding on Pain and Physiological Parameters During Heel Lancing
A study testing Acupressure and Father's Lap in people with Infant Development and Nurse's Role, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Neonatal heel blood collection is a common medical procedure to obtain blood samples from newborns for diagnostic purposes. Although necessary for clinical evaluation, this procedure causes discomfort and distress in infants. Read more about this study
- Who is it for?
- Ages 0 to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Development, Nurse's Role, Pain, Acute
- What is being tested?
- Acupressure and Father's Lap
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2024to 15 Aug 2024
- 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 0 to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being a term newborn
- A healthy newborn with its mother by its side
- Not taking any analgesic/sedative medication within 24 hours
- The baby has not undergone invasive procedures other than routine interventions
Who cannot join
- Preterm-postterm newborn
- Having a systemic disease
- Taking analgesic/sedative medication in the last 24 hours
- Invasive procedures other than routine interventions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Acupressure and Paternal Holding on Pain and Physiological Parameters in Infants During Heel Lancing: a Randomized Controlled Trial
Neonatal heel blood collection is a common medical procedure to obtain blood samples from newborns for diagnostic purposes. Although necessary for clinical evaluation, this procedure causes discomfort and distress in infants. The pain experienced during heel prick is a major concern and warrants exploration of effective and compassionate interventions to alleviate associated discomfort and reduce crying time. Non-pharmacological approaches, such as acupressure and cuddling, are thought to have important contributions to improving the overall experience of newborns undergoing this procedure. . The aim of this study was to evaluate the efficacy of acupressure and paternal hugging interventions in relieving pain and reducing crying time during neonatal heel haemorrhage. The choice of these interventions was based on their potential to offer non-invasive and holistic approaches to pain management by addressing not only the physical but also the emotional dimensions of the neonatal experience.
Read the detailed description
Neonatal heel prick blood collection is a common medical procedure performed to obtain blood samples from newborns for diagnostic purposes. Neonatal heel prick plays an important role in the diagnosis of genetic and metabolic diseases such as hypothyroidism and phenylketonuria. Although necessary for clinical evaluation, this procedure causes discomfort and distress in infants. Pain during heel prick is a major concern and warrants exploration of effective and compassionate interventions to alleviate the associated discomfort and reduce crying time. In this sense, there are studies on both heel prick instruments and interventions applied to the infant during heel prick. Non-pharmacological approaches such as acupressure and hugging are thought to have important contributions to improving the overall experience of newborns undergoing this procedure. It is known that one of the most important determinants of attachment in the postnatal period is touch, hugging and skin-to-skin contact. The neonatal period is a critical developmental stage characterised by rapid physiological and neurological changes. It is thought that the sensitivity of newborns to pain and early painful experiences may have potential long-term effects. There are studies suggesting that painful procedures may be effective in mother-baby or father-baby attachment. While there are studies in the literature on mother's hug, no study on father's hug was found. Due to the role of the presence of fathers in paediatric pain management, the potential to provide emotional support, the father's hug as a form of comforting touch, contributing to the release of oxytocin, a hormone associated with attachment and stress reduction, and the emotional bond established through hugging may act as a buffer against distress associated with painful procedures and promote a sense of security and assurance in the infant, it was considered appropriate to use it in this study. Acupressure, derived from traditional Chinese medicine, involves applying manual pressure to specific points on the body to promote healing and relieve pain. Similarly, emotional support provided by a carer, such as a father, through cuddling is thought to have the potential to reduce stress and improve the infant's emotional well-being. In this study, investigators aimed to evaluate the effectiveness of acupressure and paternal hug interventions in relieving pain and reducing crying time during neonatal heel haemorrhage. The choice of these interventions was based on their potential to offer non-invasive and holistic approaches to pain management by addressing not only the physical but also the emotional dimensions of the neonatal experience.
- Conditions
- Infant Development, Nurse's Role, Pain, Acute
- Being tested
- Acupressure, Father's Lap
- Keywords
- acupressure, heel lancing, infant, father's lap
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressureOther
Acupressure will be applied to the foreheads of the babies in this group starting two minutes before the heel prick. Acupressure application will be finished when heel prick blood collection is finished.
Father's LapOther
Infants in this group will be placed on the father's lap two minutes before heel prick blood collection. They will remain on the father's lap during the heel prick procedure.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure | Experimental | Not described Receives: Other: Acupressure |
| Paternal Holding | Experimental | Not described Receives: Other: Father's Lap |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
Pain will be assessed using the Neonatal Pain, Agitation, Sedation Scale. The minimum score of the scale is 0 and the maximum score is 10. Four points and below is considered as mild pain, five points and above is considered as moderate and severe pain.
Measured: pre-intervention, immediately after the intervention
Pulse value
Pulse value will be assessed using the infant pulse oximeter.
Measured: pre-intervention, immediately after the intervention
Crying time
Crying time will be recorded throughout the procedure.
Measured: During the intervention
Saturation value
Saturation value will be assessed using the infant pulse oximeter.
Measured: pre-intervention, immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start15 Aug 2024
- Primary completion15 Aug 2024
- Study completion15 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Infant DevelopmentStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Collaborators
- Mersin University
- Responsible party
- Principal investigator, Ilcim Ercan Koyuncu, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513897
- Sponsor's protocol ID
- Heel Lancing
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoarau K, Payet ML, Zamidio L, Bonsante F, Iacobelli S. "Holding-Cuddling" and Sucrose for Pain Relief During Venepuncture in Newborn Infants: A Randomized, Controlled Trial (CASA). Front Pediatr. 2021 Jan 14;8:607900. doi: 10.3389/fped.2020.607900. eCollection 2020.
PubMed 33520895Devi R, Priyadarshi M, Singh P, Chaurasia S, Basu S. Neonatal Pain Response to Various Heel Prick Devices: A Randomized Controlled Trial. Indian Pediatr. 2023 Nov 15;60(11):893-898. Epub 2023 Jun 21.
PubMed 37551876Adeli M, Aradmehr M. A comparative study of maternal-neonate abdominal and kangaroo (skin-to-skin) skin contact immediately after birth on maternal attachment behaviors up to 2 months. J Educ Health Promot. 2018 Mar 1;7:42. doi: 10.4103/jehp.jehp_46_16. eCollection 2018.
PubMed 29619393Abraham E, Hendler T, Shapira-Lichter I, Kanat-Maymon Y, Zagoory-Sharon O, Feldman R. Father's brain is sensitive to childcare experiences. Proc Natl Acad Sci U S A. 2014 Jul 8;111(27):9792-7. doi: 10.1073/pnas.1402569111. Epub 2014 May 27.
PubMed 24912146
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Acupressure and Paternal Holding on Pain and Physiological Parameters in Infants During Heel Lancing: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06513897
- Acronym / sponsor ID
- Heel Lancing
- Conditions
- Infant Development, Nurse's Role, Pain, Acute
- Keywords
- acupressure, heel lancing, infant, father's lap
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Collaborators
- Mersin University
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 15 Aug 2024 (actual)
- Study completion
- 15 Aug 2024 (actual)
- First posted
- 22 Jul 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.
Neonatal heel blood collection is a common medical procedure to obtain blood samples from newborns for diagnostic purposes. Although necessary for clinical evaluation, this procedure causes discomfort and distress in infants. The pain experienced during heel prick is a major concern and warrants exploration of effective and compassionate interventions to alleviate associated discomfort and reduce crying time. Non-pharmacological approaches, such as acupressure and cuddling, are thought to have important contributions to improving the overall experience of newborns undergoing this procedure. . The aim of this study was to evaluate the efficacy of acupressure and paternal hugging interventions in relieving pain and reducing crying time during neonatal heel haemorrhage. The choice of these interventions was based on their potential to offer non-invasive and holistic approaches to pain management by addressing not only the physical but also the emotional dimensions of the neonatal experience.
Detailed description
Neonatal heel prick blood collection is a common medical procedure performed to obtain blood samples from newborns for diagnostic purposes. Neonatal heel prick plays an important role in the diagnosis of genetic and metabolic diseases such as hypothyroidism and phenylketonuria. Although necessary for clinical evaluation, this procedure causes discomfort and distress in infants. Pain during heel prick is a major concern and warrants exploration of effective and compassionate interventions to alleviate the associated discomfort and reduce crying time. In this sense, there are studies on both heel prick instruments and interventions applied to the infant during heel prick. Non-pharmacological approaches such as acupressure and hugging are thought to have important contributions to improving the overall experience of newborns undergoing this procedure. It is known that one of the most important determinants of attachment in the postnatal period is touch, hugging and skin-to-skin contact. The neonatal period is a critical developmental stage characterised by rapid physiological and neurological changes. It is thought that the sensitivity of newborns to pain and early painful experiences may have potential long-term effects. There are studies suggesting that painful procedures may be effective in mother-baby or father-baby attachment. While there are studies in the literature on mother's hug, no study on father's hug was found. Due to the role of the presence of fathers in paediatric pain management, the potential to provide emotional support, the father's hug as a form of comforting touch, contributing to the release of oxytocin, a hormone associated with attachment and stress reduction, and the emotional bond established through hugging may act as a buffer against distress associated with painful procedures and promote a sense of security and assurance in the infant, it was considered appropriate to use it in this study. Acupressure, derived from traditional Chinese medicine, involves applying manual pressure to specific points on the body to promote healing and relieve pain. Similarly, emotional support provided by a carer, such as a father, through cuddling is thought to have the potential to reduce stress and improve the infant's emotional well-being. In this study, investigators aimed to evaluate the effectiveness of acupressure and paternal hug interventions in relieving pain and reducing crying time during neonatal heel haemorrhage. The choice of these interventions was based on their potential to offer non-invasive and holistic approaches to pain management by addressing not only the physical but also the emotional dimensions of the neonatal experience.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acupressure | Experimental | Other: Acupressure |
| Paternal Holding | Experimental | Other: Father's Lap |
| Control | No intervention | – |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Being a term newborn
- A healthy newborn with its mother by its side
- Not taking any analgesic/sedative medication within 24 hours
- The baby has not undergone invasive procedures other than routine interventions
Key exclusion criteria (4 listed)
- Preterm-postterm newborn
- Having a systemic disease
- Taking analgesic/sedative medication in the last 24 hours
- Invasive procedures other than routine interventions
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 |
|---|---|---|
| AcupressureAcupressure will be applied to the foreheads of the babies in this group starting two minutes before the heel prick. Acupressure application will be finished when heel prick blood collection is finished. | Other | Acupressure |
| Father's LapInfants in this group will be placed on the father's lap two minutes before heel prick blood collection. They will remain on the father's lap during the heel prick procedure. | Other | Paternal Holding |
Primary outcome
Pain Score
Time frame: pre-intervention, immediately after the intervention
Pain will be assessed using the Neonatal Pain, Agitation, Sedation Scale. The minimum score of the scale is 0 and the maximum score is 10. Four points and below is considered as mild pain, five points and above is considered as moderate and severe pain.
Pulse value
Time frame: pre-intervention, immediately after the intervention
Pulse value will be assessed using the infant pulse oximeter.
Crying time
Time frame: During the intervention
Crying time will be recorded throughout the procedure.
Saturation value
Time frame: pre-intervention, immediately after the intervention
Saturation value will be assessed using the infant pulse oximeter.
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 17 Dec 2024.
- Background: PubMed 33520895Hoarau K, Payet ML, Zamidio L, Bonsante F, Iacobelli S. "Holding-Cuddling" and Sucrose for Pain Relief During Venepuncture in Newborn Infants: A Randomized, Controlled Trial (CASA). Front Pediatr. 2021 Jan 14;8:607900. doi: 10.3389/fped.2020.607900. eCollection 2020.
- Background: PubMed 37551876Devi R, Priyadarshi M, Singh P, Chaurasia S, Basu S. Neonatal Pain Response to Various Heel Prick Devices: A Randomized Controlled Trial. Indian Pediatr. 2023 Nov 15;60(11):893-898. Epub 2023 Jun 21.
- Background: PubMed 29619393Adeli M, Aradmehr M. A comparative study of maternal-neonate abdominal and kangaroo (skin-to-skin) skin contact immediately after birth on maternal attachment behaviors up to 2 months. J Educ Health Promot. 2018 Mar 1;7:42. doi: 10.4103/jehp.jehp_46_16. eCollection 2018.
- Background: PubMed 24912146Abraham E, Hendler T, Shapira-Lichter I, Kanat-Maymon Y, Zagoory-Sharon O, Feldman R. Father's brain is sensitive to childcare experiences. Proc Natl Acad Sci U S A. 2014 Jul 8;111(27):9792-7. doi: 10.1073/pnas.1402569111. Epub 2014 May 27.
- 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 Acupressure and Father's Lap in people with Infant Development and Nurse's Role, run by Baskent 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 4 inclusion and 4 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 17 Dec 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?
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?
Pain Score (time frame: pre-intervention, immediately after the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06513897, which also lists 4 linked publications.
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 17 Dec 2024.