Newborn; VitalityNCT06214104
Acupressure Therapy Method and Heel Blood Effect of Position on Pain and Physiological Parameters
A study testing Acupressur in people with Newborn; Vitality, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
It is important that integrated methods, which will not have a negative impact on the future health of babies who have just started life, are used in neonatal pain management by nurses who are in direct contact with babies, in terms of their ease of applicability. Read more about this study
- Who is it for?
- Ages 1 week to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Newborn; Vitality
- What is being tested?
- Acupressur
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Feb 2024to 1 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 1 week to 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Birth week 38-40,
- Within the first fifteen days of postnatal
- Birth weight is 2500-4000 grams,
- whose general condition is stable,
- He is with his mother and is literate,
- Mothers and newborns who agreed to participate in the research.
Who cannot join
- In need of oxygen support,
- Fed by orogastric tube,
- In need of parenteral nutrition,
- Receiving analgesic treatment,
- Having physical, metabolic and genetic diseases,
- Before the procedure, the Neonatal Infant Pain Scale (NIPS) score is ≥ 3 and above,
- Newborns who were hospitalized in the neonatal intensive care unit
Trial locations and contacts
1 site in 1 country.
Gizem Oran Düzenli, 1 contact
About this study
Official title: Acupressure Therapy Method Applied in Newborn Heel Blood Collection and Fetus Effect of Position on Pain and Physiological Parameters
It is important that integrated methods, which will not have a negative impact on the future health of babies who have just started life, are used in neonatal pain management by nurses who are in direct contact with babies, in terms of their ease of applicability. In addition, considering that by reducing the pain of newborns, their comfort will increase, mother-baby bonding will be greater, the newborn's adaptation to the outside world will increase, and sensory neural development will be positively affected. It is important for shaping. When the literature was examined, no study was found that examined the effect of the acupressure therapy method applied during heel blood collection of newborns and the effect of the fetal position on pain together. Accordingly, our study aimed to investigate the effects of these two important methods on pain and physiological parameters in newborns.
Read the detailed description
According to the World Health Organization (WHO), the neonatal period covers the first 28 days of life from birth. A healthy newborn; It is a baby born between 38-40 weeks of gestation in the uterus, who cries after birth, adapts easily to the outside world, and does not have physiological, pathological or neurological problems (Deniz, 2023). It is important to detect some diseases that can be diagnosed early in the neonatal period so that the baby can have a healthy later life (Perry, 2018). These diseases; phenylketonuria (PKU), congenital hypothyroidism (CH), biotinidase deficiency (BE), cystic fibrosis (CF), Congenital Adrenal Hyperplasia, and Spinal Muscular Atrophy (SMA) (TC Ministry of Health). When these diseases are diagnosed early, the damage that may occur in the newborn can be reduced or eliminated with the necessary treatment and precautions (İçke, 2017). Screenings are carried out as a public health measure all over the world and in our country to detect these diseases for early diagnosis in the neonatal period (TC Ministry of Health). Most of these diseases, determined by heel blood collection and laboratory examinations, can be detected within the first two weeks (Bayrak, and Ünsal, 2021). The best time to take a blood sample is between the 36th and 72nd hours after birth. In addition, it is preferred that the baby has been feeding for 48 hours in order to perform scans (Ovalı, 2019; Bayrak and Ünsal, 2022). Taking a heel blood sample is a painful procedure for newborns. In the past, it was accepted that newborns did not feel pain and did not remember pain experiences because they were biologically immature. However, in recent years, studies in this field have been carried out in the 20-24 weeks of fetal life. It has been shown that the patient has the ability to respond to pain starting from weeks (Inmakulada et al, 2023). Pain perception is affected by the age, developmental level, cognitive and communication skills of babies and children, as well as previous pain experiences and beliefs (Varela, 2014;). It is also reported that painful stimuli change the perception of pain in the long term, increasing chronic pain syndromes and somatic complaints, and causing learning disorders, behavioral problems and attention deficit in the future as a result of recurrent pain (Akcan.2017; Eroğlu, 2018; Kahraman,2020; Glenzel,2023). . In line with this information, importance has begun to be given to the pain management of newborn babies in the literature and scales that detect pain have been developed (Bucsea 2019; Karakoç and Aydın 2022; Glenzel, 2023; It is noteworthy that there are more pharmacological methods to reduce pain in newborns. However, pharmacological applications in newborns have side effects and newborns It has been shown in literature studies that it will have a negative effect on the patient (Akcan, Polat, 2017). For this reason, integrative treatment methods, which are widely used today, are more recommended for neonatal pain management (Guney, 2017). Because these methods are non-invasive and do not cause any side effects. Its use is more encouraged. When the literature is examined, the integrative methods used in heel blood collection include breastfeeding, fetal position, swaddling, pacifier giving, oral glucose, acupressure, foot reflexology, kangaroo care, breast milk smell, mother and father's voice, mother's heart sound, music, white noise, There are many methods such as amniotic fluid smell, lavender smell (Aygül.2023; Memiş, 2023; Atal, 2019; Kale, 2019; Şafak, 2021; Tuncay, 2020; Deniz, 2019; Oğul, 2018; Avçin, 2017). There have been studies reporting that these methods have various effects on pain in newborns (Glenzel, 2023; Karakoç, 2022; Ceylan, 2017).
It has been reported that acupressure application reduces pain and anxiety in newborns, especially due to invasive interventional procedures (Deniz, 2019). Acupressure reveals the body's self-healing mechanism by making biochemical changes in the body. Acupressure affects the pain mechanism by applying pressure to acupuncture points (Özkan and Balcı, 2018). When studies in the literature are examined, it is reported that acupressure applied during heel blood collection reduces the newborn pain score (Deniz, 2019). Another nonpharmacological method used to reduce pain is the fetal position. Fetal position; It is a sub-form of the method of taking the baby into the nest and is the process of keeping the baby's upper and lower extremities in flexion with the hand and placing the body in a closed position close to the midline. It is reported that this method activates the regulatory systems of babies by providing heat and tactile stimulation, blocks painful stimuli from the external environment and reduces the pain felt by the baby (Avçin, 2015; Kemer and İşler, 2020). In a study, the effect of the fetal position during heel blood collection on pain, heart rate and oxygen saturation was examined and it was reported that the average pain score of babies in the fetal position was lower (Kale, 2018). It is important that integrated methods, which will not have a negative impact on the future health of babies who have just started life, are used in neonatal pain management by nurses who are in direct contact with babies, in terms of their ease of applicability. In addition, considering that by reducing the pain of newborns, their comfort will increase, mother-baby bonding will be greater, the newborn's adaptation to the outside world will increase, and sensory neural development will be positively affected. It is important for shaping. When the literature was examined, no study was found that examined the effect of the acupressure therapy method applied during heel blood collection of newborns and the effect of the fetal position on pain together. Accordingly, our study aimed to investigate the effects of these two important methods on pain and physiological parameters in newborns.
- Conditions
- Newborn; Vitality
- Being tested
- Acupressur
- Keywords
- Newborn, heels lancet, acupressure, fetal position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupressurBehavioural
Also called fetal position
Acupressure Massage; It will be applied to BL 60 and K3 areas. The application will be applied in successive pressures with the thumb on each point for an average of 45-60 seconds.The fetal position will be given with the newborn in the right side position, with the arms and legs joined in the midline.
| Study group | Role | What they receive |
|---|---|---|
| acupressure | Experimental | Acupressure Massage; It will be applied to BL 60 and K3 areas. The application will be applied in successive pressures with the thumb on each point for an average of 45-60 seconds. Receives: Behavioral: Acupressur |
| fetal position | Experimental | The fetal position will be given with the newborn in the right side position, with the arms and legs joined in the midline. Receives: Behavioral: Acupressur |
| Control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Infant Pain Scale:NIPS
It is a scale whose validity and reliability was established by Lawrence in 1993 for preterm and term babies and is used to evaluate the pain experienced by the newborn until the 6th week. It was developed to evaluate the behavioral pain responses of newborn babies 2 minutes before invasive procedures, 5 minutes during the procedure, and 3 minutes after the procedure.
Measured: 5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Newborn; VitalityStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arzu Abic, 1, Study director, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214104
- Sponsor's protocol ID
- ETK00-2023-0237
- Other IDs
- Hulya Fırat Kılıc
- Status last verified
- Jan 2024
- First submitted
- 10 Jan 2024
- Last updated
- 19 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Lemus-Varela Mde L, Sola A, Golombek S, Baquero H, Borbonet D, Davila-Aliaga C, Del Moral T, Lara-Flores G, Lima-Rogel MV, Neira-Safi F, Natta D, Oviedo-Barrantes A, Rodriguez S; Consenso Clinico de Dolor y Estres Neonatal, de la Sociedad Iberoamericana de Neonatologia (SIBEN). [Consensus on the diagnostic and therapeutic approach to pain and stress in the newborn]. Rev Panam Salud Publica. 2014 Nov;36(5):348-54. Spanish.
PubMed 25604106Yilmaz D, Inal S. Effects of three different methods used during heel lance procedures on pain level in term neonates. Jpn J Nurs Sci. 2020 Oct;17(4):e12338. doi: 10.1111/jjns.12338. Epub 2020 Apr 2.
PubMed 32239753
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupressure Therapy Method Applied in Newborn Heel Blood Collection and Fetus Effect of Position on Pain and Physiological Parameters
- ClinicalTrials.gov ID
- NCT06214104
- Acronym / sponsor ID
- ETK00-2023-0237
- Conditions
- Newborn; Vitality
- Keywords
- Newborn, heels lancet, acupressure, fetal position
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 19 Jan 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.
It is important that integrated methods, which will not have a negative impact on the future health of babies who have just started life, are used in neonatal pain management by nurses who are in direct contact with babies, in terms of their ease of applicability. In addition, considering that by reducing the pain of newborns, their comfort will increase, mother-baby bonding will be greater, the newborn's adaptation to the outside world will increase, and sensory neural development will be positively affected. It is important for shaping. When the literature was examined, no study was found that examined the effect of the acupressure therapy method applied during heel blood collection of newborns and the effect of the fetal position on pain together. Accordingly, our study aimed to investigate the effects of these two important methods on pain and physiological parameters in newborns.
Detailed description
According to the World Health Organization (WHO), the neonatal period covers the first 28 days of life from birth. A healthy newborn; It is a baby born between 38-40 weeks of gestation in the uterus, who cries after birth, adapts easily to the outside world, and does not have physiological, pathological or neurological problems (Deniz, 2023). It is important to detect some diseases that can be diagnosed early in the neonatal period so that the baby can have a healthy later life (Perry, 2018). These diseases; phenylketonuria (PKU), congenital hypothyroidism (CH), biotinidase deficiency (BE), cystic fibrosis (CF), Congenital Adrenal Hyperplasia, and Spinal Muscular Atrophy (SMA) (TC Ministry of Health). When these diseases are diagnosed early, the damage that may occur in the newborn can be reduced or eliminated with the necessary treatment and precautions (İçke, 2017). Screenings are carried out as a public health measure all over the world and in our country to detect these diseases for early diagnosis in the neonatal period (TC Ministry of Health). Most of these diseases, determined by heel blood collection and laboratory examinations, can be detected within the first two weeks (Bayrak, and Ünsal, 2021). The best time to take a blood sample is between the 36th and 72nd hours after birth. In addition, it is preferred that the baby has been feeding for 48 hours in order to perform scans (Ovalı, 2019; Bayrak and Ünsal, 2022). Taking a heel blood sample is a painful procedure for newborns. In the past, it was accepted that newborns did not feel pain and did not remember pain experiences because they were biologically immature. However, in recent years, studies in this field have been carried out in the 20-24 weeks of fetal life. It has been shown that the patient has the ability to respond to pain starting from weeks (Inmakulada et al, 2023). Pain perception is affected by the age, developmental level, cognitive and communication skills of babies and children, as well as previous pain experiences and beliefs (Varela, 2014;). It is also reported that painful stimuli change the perception of pain in the long term, increasing chronic pain syndromes and somatic complaints, and causing learning disorders, behavioral problems and attention deficit in the future as a result of recurrent pain (Akcan.2017; Eroğlu, 2018; Kahraman,2020; Glenzel,2023). . In line with this information, importance has begun to be given to the pain management of newborn babies in the literature and scales that detect pain have been developed (Bucsea 2019; Karakoç and Aydın 2022; Glenzel, 2023; It is noteworthy that there are more pharmacological methods to reduce pain in newborns. However, pharmacological applications in newborns have side effects and newborns It has been shown in literature studies that it will have a negative effect on the patient (Akcan, Polat, 2017). For this reason, integrative treatment methods, which are widely used today, are more recommended for neonatal pain management (Guney, 2017). Because these methods are non-invasive and do not cause any side effects. Its use is more encouraged. When the literature is examined, the integrative methods used in heel blood collection include breastfeeding, fetal position, swaddling, pacifier giving, oral glucose, acupressure, foot reflexology, kangaroo care, breast milk smell, mother and father's voice, mother's heart sound, music, white noise, There are many methods such as amniotic fluid smell, lavender smell (Aygül.2023; Memiş, 2023; Atal, 2019; Kale, 2019; Şafak, 2021; Tuncay, 2020; Deniz, 2019; Oğul, 2018; Avçin, 2017). There have been studies reporting that these methods have various effects on pain in newborns (Glenzel, 2023; Karakoç, 2022; Ceylan, 2017).
It has been reported that acupressure application reduces pain and anxiety in newborns, especially due to invasive interventional procedures (Deniz, 2019). Acupressure reveals the body's self-healing mechanism by making biochemical changes in the body. Acupressure affects the pain mechanism by applying pressure to acupuncture points (Özkan and Balcı, 2018). When studies in the literature are examined, it is reported that acupressure applied during heel blood collection reduces the newborn pain score (Deniz, 2019). Another nonpharmacological method used to reduce pain is the fetal position. Fetal position; It is a sub-form of the method of taking the baby into the nest and is the process of keeping the baby's upper and lower extremities in flexion with the hand and placing the body in a closed position close to the midline. It is reported that this method activates the regulatory systems of babies by providing heat and tactile stimulation, blocks painful stimuli from the external environment and reduces the pain felt by the baby (Avçin, 2015; Kemer and İşler, 2020). In a study, the effect of the fetal position during heel blood collection on pain, heart rate and oxygen saturation was examined and it was reported that the average pain score of babies in the fetal position was lower (Kale, 2018). It is important that integrated methods, which will not have a negative impact on the future health of babies who have just started life, are used in neonatal pain management by nurses who are in direct contact with babies, in terms of their ease of applicability. In addition, considering that by reducing the pain of newborns, their comfort will increase, mother-baby bonding will be greater, the newborn's adaptation to the outside world will increase, and sensory neural development will be positively affected. It is important for shaping. When the literature was examined, no study was found that examined the effect of the acupressure therapy method applied during heel blood collection of newborns and the effect of the fetal position on pain together. Accordingly, our study aimed to investigate the effects of these two important methods on pain and physiological parameters in newborns.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| acupressure | Experimental | Behavioral: AcupressurAcupressure Massage; It will be applied to BL 60 and K3 areas. The application will be applied in successive pressures with the thumb on each point for an average of 45-60 seconds. |
| fetal position | Experimental | Behavioral: AcupressurThe fetal position will be given with the newborn in the right side position, with the arms and legs joined in the midline. |
| Control group | No intervention | –no intervention |
Who may qualify
- Ages
- 1 week to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Birth week 38-40,
- Within the first fifteen days of postnatal
- Birth weight is 2500-4000 grams,
- whose general condition is stable,
- He is with his mother and is literate,
Key exclusion criteria (7 listed)
- In need of oxygen support,
- Fed by orogastric tube,
- In need of parenteral nutrition,
- Receiving analgesic treatment,
- Having physical, metabolic and genetic diseases,
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 |
|---|---|---|
| AcupressurAlso: fetal positionAcupressure Massage; It will be applied to BL 60 and K3 areas. The application will be applied in successive pressures with the thumb on each point for an average of 45-60 seconds.The fetal position will be given with the newborn in the right side position, with the arms and legs joined in the midline. | Behavioural | acupressure, fetal position |
Primary outcome
Neonatal Infant Pain Scale:NIPS
Time frame: 5 month
It is a scale whose validity and reliability was established by Lawrence in 1993 for preterm and term babies and is used to evaluate the pain experienced by the newborn until the 6th week. It was developed to evaluate the behavioral pain responses of newborn babies 2 minutes before invasive procedures, 5 minutes during the procedure, and 3 minutes after the procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Results publication: PubMed 25604106Lemus-Varela Mde L, Sola A, Golombek S, Baquero H, Borbonet D, Davila-Aliaga C, Del Moral T, Lara-Flores G, Lima-Rogel MV, Neira-Safi F, Natta D, Oviedo-Barrantes A, Rodriguez S; Consenso Clinico de Dolor y Estres Neonatal, de la Sociedad Iberoamericana de Neonatologia (SIBEN). [Consensus on the diagnostic and therapeutic approach to pain and stress in the newborn]. Rev Panam Salud Publica. 2014 Nov;36(5):348-54. Spanish.
- Results publication: PubMed 32239753Yilmaz D, Inal S. Effects of three different methods used during heel lance procedures on pain level in term neonates. Jpn J Nurs Sci. 2020 Oct;17(4):e12338. doi: 10.1111/jjns.12338. Epub 2020 Apr 2.
- 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.
Gizem Oran Düzenli, 1 contact
Arzu Abic, 1 study director
Eastern Mediterranean 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 Acupressur in people with Newborn; Vitality, run by Eastern Mediterranean University at 1 site in Cyprus.
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 6 inclusion and 7 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 19 Jan 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 Cyprus. 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 Gizem Oran Duzenli, 1 (05338874421, gizem.duzenli@emu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal Infant Pain Scale:NIPS (time frame: 5 month). 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 NCT06214104, which also lists 2 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 19 Jan 2024.