PainNCT05442619
Developing a Portable Therapeutic Baby Nest for Newborns and Evaluation During Venous Blood Collection
A study testing Venous blood collection in people with Pain and Newborn, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The neonatal period covers the first 28 days after birth. Newborns may experience problems such as jaundice, restlessness, nasal congestion, respiratory distress, and vomiting in this process, and for these reasons, children are brought to the emergency services. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- What is being tested?
- Venous blood collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 30 Sep 2022
- 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
- 37-42 weeks of gestation,
- Birth weight between 2500-4000 g,
- Being less than 28 postnatal days,
- The family can speak and understand Turkish,
- Newborns with written and verbal informed consent from their families
Who cannot join
- Having an analgesic intake 4 hours before, which may affect their comfort and behavior
- Presence of congenital anomaly,
- Having respiratory distress,
- Newborns with clinically unstable (vital and physical examination findings)
- Newborns with suspected or diagnosed Covid 19
- Newborns with vision and hearing problems
- Inability to perform blood collection at once
- Newborns have a history of hospitalization
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Sami Ulus Maternity and Child Health and Diseases Training and Research Hospital
Ankara, Altındağ, 06080
About this study
Official title: Developing a Portable Therapeutic Baby Nest for Newborns and Evaluation of the Effect on Comfort and Pain Levels During Venous Blood Collection
The neonatal period covers the first 28 days after birth. Newborns may experience problems such as jaundice, restlessness, nasal congestion, respiratory distress, and vomiting in this process, and for these reasons, children are brought to the emergency services. From the moment they enter the emergency service, they are exposed to sensory stimuli in the form of bright lights, loud and unusual sounds, and new tactile experiences. This creates an uncomfortable and stressful experience for them. At the same time, performing invasive procedural interventions in an environment where stimuli are intense causes pain. Newborns give physiological, behavioral and metabolic responses depending on the pain and stress they experience. Persistent exposure to these interventions and lack of appropriate approaches may lead to deterioration in pain perceptions and neuroendocrine stress responses, and permanent neurological and behavioral problems may develop over time. For this reason, pain in newborns and the problems caused by stress should be known, appropriate pain relief methods should be selected and comfort should be provided. However, pediatric emergency nurses who perform the procedural methods of newborns whose rates of admission to pediatric emergency services are reported as 2-3% may not have sufficient experience in pain management in newborns. Pediatric emergency nurses need to be supported in order to increase their awareness of newborns and to continue their pain management. While it has been reported in the literature that there are non-pharmacological methods including individualized developmental care practices in the procedural pain management of newborns; there are no studies aimed at reducing their pain, preventing their exposure to environmental factors and ensuring their comfort during painful procedures in pediatric emergency departments. In this context, it is planned to use a portable therapeutic baby nest in the pediatric emergency department, where newborns will feel safe and maintain their flexion posture during the venous blood sampling, as well as be protected from noise and light, thereby reducing the pain caused by the procedural method and providing comfort, and a randomized controlled experimental study.
Read the detailed description
The neonatal period covers the first 28 days after birth. During this period, newborns may experience problems such as jaundice, restlessness, nasal congestion, respiratory distress, and vomiting, and for these reasons, children can be brought to the emergency services. From the moment they enter the emergency room, they are exposed to sensory stimuli in the form of bright lights, loud and unusual sounds, and new tactile experiences. This creates an uncomfortable and stressful experience for them. At the same time, performing invasive procedural interventions in an environment where stimuli are intense causes pain. Newborns give physiological, behavioral and metabolic responses depending on the pain and stress they experience. Persistent exposure to these interventions and lack of appropriate approaches may lead to deterioration in pain perceptions and neuroendocrine stress responses, and permanent neurological and behavioral problems may develop over time. For this reason, pain in newborns and the problems caused by stress should be known, appropriate pain relief methods should be selected and comfort should be provided. However, pediatric emergency nurses who perform the procedural procedures of newborns whose rates of admission to pediatric emergency services are reported as 2-3% may not have sufficient experience in pain management. Pediatric emergency nurses need to be supported in order to increase their awareness of newborns and to continue their pain management. Although there is a large literature examining the effects of individualized developmental care practices in painful invasive procedural procedures for newborns, there are no studies examining the effects of these practices in painful invasive procedural procedures in pediatric emergencies. In this context, there is a need for an environment in which invasive procedural procedures specific to them are carried out in pediatric emergency services for newborns with the highest sensitivity to environmental factors and susceptibility to infections. In this study, newborns will feel safe, protect their flexion posture, and be protected from noise and light during the venous blood collection procedure, which is unique and cost-effective in terms of its applicability in each pediatric emergency department, thus reducing the pain caused by the procedural procedure and providing comfort. It is aimed to develop and evaluate the effectiveness of the portable therapeutic baby nursery. With these aspects, it is the first study in the literature to be conducted in the pediatric emergency department and will be carried out in two stages. In the first stage of the study, a portable therapeutic baby nursery will be developed, and in the second stage, its effectiveness during venous blood collection will be evaluated. Nest is an environment specific to newborns in the medical field; thanks to its design; It helps newborns to reduce the light and sound that they will be exposed to in a noisy and high light environment such as a pediatric emergency, to provide comfort and reduce pain by therapeutic touch and maintaining their therapeutic position, at the same time to protect body temperature by preventing contact with cold material such as linoleum on the stretcher and over the stretcher. will contribute to the prevention of exposure to any infectious agent. Thanks to this new and field-specific application, information about the individualized developmental care practices of newborns in the pediatric emergency service will be provided to the literature.
- Being tested
- Venous blood collection
- Keywords
- light, noise, baby nest, pediatric emergency
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous blood collectionProcedure or surgery
Venous blood will be drawn from newborns.
| Study group | Role | What they receive |
|---|---|---|
| Portable therapeutic baby nest group | Experimental | Blood will be drawn from newborns using the portable therapeutic baby nest. Receives: Procedure: Venous blood collection |
| Control group | Active comparator | Blood collection from newborns will be done according to the clinical routine. Receives: Procedure: Venous blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosedural Pain
"The Neonatal-Infant Pain (NIPS) Scale" will be used to measure the pain levels of newborns during the blood collection.
Neonatal Infant Pain Scale (NIPS): The Neonatal Infant Pain Scale (NIPS), developed by Lawrence et al. (1993), is a behavioral scale and can be used with both full-term and preterm infants. In NIPS, five behavioral indicators (facial expression, cry, arms, legs, and state of arousal) and one physiological parameter (breathing pattern) are assessed. The total pain score ranges between 0 and 7 with 0-2 points indicating mild to no pain, 3-4 indicating mild to moderate pain, and greater than 4 indicating severe pain (Lawrence et al., 1993). The scale was adapted to Turkish. Cronbach alpha internal consistency coefficient was found between 0.83 and 0.86 (Akdovan et al., 1999).
Measured: In each infant, the level of pain will be evaluated in an average of 6 minutes.
Comfort
"COMFORTneo Scale" will be used to measure the comfort levels of newborns during the blood collection.
COMFORTneo Scale: The COMFORTneo scale is used to assess the comfort levels of infants. This scale is a Likert-type scale consisting of seven parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tonus. The lowest score on the scale is 6 and the highest is 30. If the total score of the scale is between 14 and 30, the infant has pain or distress, is uncomfortable, and needs intervention to provide comfort. The validity and reliability study of the Turkish version of the scale was conducted. Cronbach's alpha coefficient of the scale was 0.82-0.92 (Kahraman et al., 2014).
Measured: In each infant, the level of comfort will be evaluated in an average of 6 minutes.
Physiological parameters- Pulse rate
Pulse oximeter will be used to record data about pulse rate (beats/minute).Pulse rate will be recorded under the titles of 2 minute before the procedure, during the procedure (during the blood collection), and 2 minutes after the procedure; Total duration (of the procedure) will be recorded in seconds.
Measured: In each infant, the level of physiologic parameters will be evaluated in an average of 6 minutes.
Physiological parameters- Oxygen saturation
Pulse oximeter will be used to record data about oxygen saturation (SpO2).Oxygen saturation will be recorded under the titles of 2 minute before the procedure, during the procedure (during the blood collection), and 2 minutes after the procedure; Total duration (of the procedure) will be recorded in seconds.
Measured: In each infant, the level of physiologic parameters will be evaluated in an average of 6 minutes
Physiological parameters-Respiration rate
A smartphone stopwatch will be used to measure respiratory rate (breaths/minute). Respiratory rate will be recorded under the titles of 2 minute before the procedure, during the procedure (during the blood collection), and 2 minutes after the procedure; Total duration (of the procedure) will be recorded in seconds.
Measured: In each infant, the level of physiologic parameters will be evaluated in an average of 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 May 2022
- Primary completion31 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Model description
- Control Group Portable Therapeutic Baby Nest Using Group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AYLİN ARIKAN, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442619
- Sponsor's protocol ID
- 56786525-050.04.04/385491
- Status last verified
- Nov 2022
- First submitted
- 23 Jun 2022
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lawrence J, Alcock D, McGrath P, Kay J, MacMurray SB, Dulberg C. The development of a tool to assess neonatal pain. Neonatal Netw. 1993 Sep;12(6):59-66.
PubMed 8413140van Dijk M, Roofthooft DW, Anand KJ, Guldemond F, de Graaf J, Simons S, de Jager Y, van Goudoever JB, Tibboel D. Taking up the challenge of measuring prolonged pain in (premature) neonates: the COMFORTneo scale seems promising. Clin J Pain. 2009 Sep;25(7):607-16. doi: 10.1097/AJP.0b013e3181a5b52a.
PubMed 19692803Arikan A, Esenay FI. Effect of a portable therapeutic baby nest designed for neonates on physiological parameters, comfort and pain levels during venous blood sampling: a randomised controlled trial. Emerg Med J. 2025 Oct 20;42(11):705-711. doi: 10.1136/emermed-2024-214660.
PubMed 40634119
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Portable Therapeutic Baby Nest for Newborns and Evaluation of the Effect on Comfort and Pain Levels During Venous Blood Collection
- ClinicalTrials.gov ID
- NCT05442619
- Acronym / sponsor ID
- 56786525-050.04.04/385491
- Keywords
- light, noise, baby nest, pediatric emergency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 5 Jul 2022 (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.
The neonatal period covers the first 28 days after birth. Newborns may experience problems such as jaundice, restlessness, nasal congestion, respiratory distress, and vomiting in this process, and for these reasons, children are brought to the emergency services. From the moment they enter the emergency service, they are exposed to sensory stimuli in the form of bright lights, loud and unusual sounds, and new tactile experiences. This creates an uncomfortable and stressful experience for them. At the same time, performing invasive procedural interventions in an environment where stimuli are intense causes pain. Newborns give physiological, behavioral and metabolic responses depending on the pain and stress they experience. Persistent exposure to these interventions and lack of appropriate approaches may lead to deterioration in pain perceptions and neuroendocrine stress responses, and permanent neurological and behavioral problems may develop over time. For this reason, pain in newborns and the problems caused by stress should be known, appropriate pain relief methods should be selected and comfort should be provided. However, pediatric emergency nurses who perform the procedural methods of newborns whose rates of admission to pediatric emergency services are reported as 2-3% may not have sufficient experience in pain management in newborns. Pediatric emergency nurses need to be supported in order to increase their awareness of newborns and to continue their pain management. While it has been reported in the literature that there are non-pharmacological methods including individualized developmental care practices in the procedural pain management of newborns; there are no studies aimed at reducing their pain, preventing their exposure to environmental factors and ensuring their comfort during painful procedures in pediatric emergency departments. In this context, it is planned to use a portable therapeutic baby nest in the pediatric emergency department, where newborns will feel safe and maintain their flexion posture during the venous blood sampling, as well as be protected from noise and light, thereby reducing the pain caused by the procedural method and providing comfort, and a randomized controlled experimental study.
Detailed description
The neonatal period covers the first 28 days after birth. During this period, newborns may experience problems such as jaundice, restlessness, nasal congestion, respiratory distress, and vomiting, and for these reasons, children can be brought to the emergency services. From the moment they enter the emergency room, they are exposed to sensory stimuli in the form of bright lights, loud and unusual sounds, and new tactile experiences. This creates an uncomfortable and stressful experience for them. At the same time, performing invasive procedural interventions in an environment where stimuli are intense causes pain. Newborns give physiological, behavioral and metabolic responses depending on the pain and stress they experience. Persistent exposure to these interventions and lack of appropriate approaches may lead to deterioration in pain perceptions and neuroendocrine stress responses, and permanent neurological and behavioral problems may develop over time. For this reason, pain in newborns and the problems caused by stress should be known, appropriate pain relief methods should be selected and comfort should be provided. However, pediatric emergency nurses who perform the procedural procedures of newborns whose rates of admission to pediatric emergency services are reported as 2-3% may not have sufficient experience in pain management. Pediatric emergency nurses need to be supported in order to increase their awareness of newborns and to continue their pain management. Although there is a large literature examining the effects of individualized developmental care practices in painful invasive procedural procedures for newborns, there are no studies examining the effects of these practices in painful invasive procedural procedures in pediatric emergencies. In this context, there is a need for an environment in which invasive procedural procedures specific to them are carried out in pediatric emergency services for newborns with the highest sensitivity to environmental factors and susceptibility to infections. In this study, newborns will feel safe, protect their flexion posture, and be protected from noise and light during the venous blood collection procedure, which is unique and cost-effective in terms of its applicability in each pediatric emergency department, thus reducing the pain caused by the procedural procedure and providing comfort. It is aimed to develop and evaluate the effectiveness of the portable therapeutic baby nursery. With these aspects, it is the first study in the literature to be conducted in the pediatric emergency department and will be carried out in two stages. In the first stage of the study, a portable therapeutic baby nursery will be developed, and in the second stage, its effectiveness during venous blood collection will be evaluated. Nest is an environment specific to newborns in the medical field; thanks to its design; It helps newborns to reduce the light and sound that they will be exposed to in a noisy and high light environment such as a pediatric emergency, to provide comfort and reduce pain by therapeutic touch and maintaining their therapeutic position, at the same time to protect body temperature by preventing contact with cold material such as linoleum on the stretcher and over the stretcher. will contribute to the prevention of exposure to any infectious agent. Thanks to this new and field-specific application, information about the individualized developmental care practices of newborns in the pediatric emergency service will be provided to the literature.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Control Group Portable Therapeutic Baby Nest Using Group
| Arm | Type | Receives |
|---|---|---|
| Portable therapeutic baby nest group | Experimental | Procedure: Venous blood collectionBlood will be drawn from newborns using the portable therapeutic baby nest. |
| Control group | Active comparator | Procedure: Venous blood collectionBlood collection from newborns will be done according to the clinical routine. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 37-42 weeks of gestation,
- Birth weight between 2500-4000 g,
- Being less than 28 postnatal days,
- The family can speak and understand Turkish,
- Newborns with written and verbal informed consent from their families
Key exclusion criteria (8 listed)
- Having an analgesic intake 4 hours before, which may affect their comfort and behavior
- Presence of congenital anomaly,
- Having respiratory distress,
- Newborns with clinically unstable (vital and physical examination findings)
- Newborns with suspected or diagnosed Covid 19
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 |
|---|---|---|
| Venous blood collectionVenous blood will be drawn from newborns. | Procedure or surgery | Control group, Portable therapeutic baby nest group |
Primary outcome
Prosedural Pain
Time frame: In each infant, the level of pain will be evaluated in an average of 6 minutes.
"The Neonatal-Infant Pain (NIPS) Scale" will be used to measure the pain levels of newborns during the blood collection. Neonatal Infant Pain Scale (NIPS): The Neonatal Infant Pain Scale (NIPS), developed by Lawrence et al. (1993), is a behavioral scale and can be used with both full-term and preterm infants. In NIPS, five behavioral indicators (facial expression, cry, arms, legs, and state of arousal) and one physiological parameter (breathing pattern) are assessed. The total pain score ranges between 0 and 7 with 0-2 points indicating mild to no pain, 3-4 indicating mild to moderate pain, and greater than 4 indicating severe pain (Lawrence et al., 1993). The scale was adapted to Turkish. Cronbach alpha internal consistency coefficient was found between 0.83 and 0.86 (Akdovan et al., 1999).
Comfort
Time frame: In each infant, the level of comfort will be evaluated in an average of 6 minutes.
"COMFORTneo Scale" will be used to measure the comfort levels of newborns during the blood collection. COMFORTneo Scale: The COMFORTneo scale is used to assess the comfort levels of infants. This scale is a Likert-type scale consisting of seven parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension, and muscle tonus. The lowest score on the scale is 6 and the highest is 30. If the total score of the scale is between 14 and 30, the infant has pain or distress, is uncomfortable, and needs intervention to provide comfort. The validity and reliability study of the Turkish version of the scale was conducted. Cronbach's alpha coefficient of the scale was 0.82-0.92 (Kahraman et al., 2014).
Physiological parameters- Pulse rate
Time frame: In each infant, the level of physiologic parameters will be evaluated in an average of 6 minutes.
Pulse oximeter will be used to record data about pulse rate (beats/minute).Pulse rate will be recorded under the titles of 2 minute before the procedure, during the procedure (during the blood collection), and 2 minutes after the procedure; Total duration (of the procedure) will be recorded in seconds.
Physiological parameters- Oxygen saturation
Time frame: In each infant, the level of physiologic parameters will be evaluated in an average of 6 minutes
Pulse oximeter will be used to record data about oxygen saturation (SpO2).Oxygen saturation will be recorded under the titles of 2 minute before the procedure, during the procedure (during the blood collection), and 2 minutes after the procedure; Total duration (of the procedure) will be recorded in seconds.
Physiological parameters-Respiration rate
Time frame: In each infant, the level of physiologic parameters will be evaluated in an average of 6 minutes
A smartphone stopwatch will be used to measure respiratory rate (breaths/minute). Respiratory rate will be recorded under the titles of 2 minute before the procedure, during the procedure (during the blood collection), and 2 minutes after the procedure; Total duration (of the procedure) will be recorded in seconds.
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 Nov 2022.
- Background: PubMed 8413140Lawrence J, Alcock D, McGrath P, Kay J, MacMurray SB, Dulberg C. The development of a tool to assess neonatal pain. Neonatal Netw. 1993 Sep;12(6):59-66.
- Background: PubMed 19692803van Dijk M, Roofthooft DW, Anand KJ, Guldemond F, de Graaf J, Simons S, de Jager Y, van Goudoever JB, Tibboel D. Taking up the challenge of measuring prolonged pain in (premature) neonates: the COMFORTneo scale seems promising. Clin J Pain. 2009 Sep;25(7):607-16. doi: 10.1097/AJP.0b013e3181a5b52a.
- Derived from this study: PubMed 40634119Arikan A, Esenay FI. Effect of a portable therapeutic baby nest designed for neonates on physiological parameters, comfort and pain levels during venous blood sampling: a randomised controlled trial. Emerg Med J. 2025 Oct 20;42(11):705-711. doi: 10.1136/emermed-2024-214660.
- 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 Venous blood collection in people with Pain and Newborn, run by Ankara 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 5 inclusion and 8 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 Nov 2022. 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?
Prosedural Pain (time frame: In each infant, the level of pain will be evaluated in an average of 6 minutes.). The study lists 5 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 NCT05442619, which also lists 3 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 Nov 2022.