Nursing CariesNCT05657977
The Effect of Swaddling Method on Stress Level in Newborns Administration to Nasal CPAP
A study testing nonpharmacologic intervention (swaddling) in people with Nursing Caries and Newborn Illness, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Transient tachypnea of newborn (TTN) causes 42.5%-60% of non-infectious respiratory distress cases in newborns, it is seen in only 1% of all newborns. In the etiology of TTN, it results from the inability to effectively clear the fetal lung fluid immediately after birth. Read more about this study
- Who is it for?
- Ages 10 minutes to 5 hours
- Conditions the study is for
- Nursing Caries, Newborn Illness, Nurse's Role
- What is being tested?
- nonpharmacologic intervention (swaddling)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2022to 1 Jun 2023
- 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 10 minutes to 5 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth week greater than 35 and birth weight greater than 2000 g,
- Need for nasal CPAP/noninvasive mechanical ventilator,
- Legal guardians' consent to participate in the research,
- Diagnosis of neonatal transient tachypnea after delivery.
Who cannot join
- Mother:
- Taking cortisol-containing medication during the antenatal period
- Taking drugs during the antenatal period
- Being chorioamnionitis
- Metabolic disease (adrenal insufficiency, etc.)
- Newborn:
Show all 19Show fewer
- Amniotic fluid stained with meconium
- Intubation
- Apgar score below 6
- Taking analgesic and narcotic drugs for sedation
- Newborn taking cortisol-containing medication
- Inability to obtain a saliva sample or if it is contaminated with blood
- Signs of nasal injury during noninvasive mechanical ventilation
- Congenital defects that will prevent the wrapping method (spina bifida, gastroschisis, etc.)
- Performing resuscitation
- Newborns with cerebral hypoxia-ischemia
- Non-respiratory (congenital pneumonia, respiratory distress syndrome, congenital heart diseases, hypocalcemia, persistent hypoglycemia) causes,
- Development of neonatal sepsis (If sepsis develops in the newborn within the postnatal 48 hours, the baby will be removed from the sample group. Whole blood, biochemistry, hemoculture, and serology tests are performed at the postnatal 24th hour in the routine practice of the unit. The patient will be excluded from the sample after laboratory tests are performed.)
- Hypocalcemia (low calcium level as a result of the blood gas sample taken while opening the vascular access before nCPAP is connected)
Trial locations and contacts
1 site in 1 country.
About this study
Transient tachypnea of newborn (TTN) causes 42.5%-60% of non-infectious respiratory distress cases in newborns, it is seen in only 1% of all newborns. In the etiology of TTN, it results from the inability to effectively clear the fetal lung fluid immediately after birth. The most known risk factors of TTN are; prematurity, malpresentation, abnormal birth, premature rupture of the membrane, meconium aspiration, fetal distress, multiple pregnancy, male gender, and low Apgar score. TTN; It typically occurs in term and late preterm newborns within the first two hours of life. For the diagnosis of TTN, respiratory rate >60/min in the first 6-12 hours shows signs of groaning and retraction and improve spontaneously within a few days with 40% or less supportive oxygen therapy.
However, in some rare cases, prolongation of symptoms, noninvasive mechanical ventilation support [nasal continuous positive airway pressure (nCPAP), nonsynchronized nasal intermittent mandatory ventilation (NIMV)] and in some cases invasive (intubated) mechanical ventilation may be required.
Reducing pain and stress in mechanically ventilated infants is important for the prevention of complications that may occur in the future-early period and for recover process. While providing standard health care in the Neonatal Intensive Care Unit (NICU), sources of pain and stress should be identified and controlled. It is necessary to minimize the interventions that will cause pain and stress and to ensure that the newborn copes with the pain. In order to relieve pain and stress, various pharmacological (opioid, non-opioid analgesics) and non-pharmacological (breast milk, pacifier, kangaroo care, flexion posture, swaddling etc.) within the framework of family-centered care and individualized developmental care methods should be used. Pain control is a priority in neonatal nursing care, and it is the nurses; responsibility to select and implement a non-pharmacological intervention to reduce the level of pain. A limited number of studies have been found examining the effects of therapeutic touch and mothers voice on pain and comfort level in newborns, as a behavioral intervention, on relieving stress of body positioning in premature newborns who underwent nCPAP. There was no study found that the swaddling method applied during the procedure in patients followed up on nCPAP had an effect on reducing the stress level of newborns.
Read the detailed description
The aim of the proposed study is to determine the effect of the swaddling method applied to newborns in noninvasive mechanical ventilators on the stress level, by using the neonatal stress scale and salivary cortisol levels.
Type of the research: The research was planned to be conducted in a single group with a pre-test, post-test pattern experimental type.
Research variables Independent variable: Swaddling method. Dependent Variables: The stress felt by the newborn and the salivary cortisol level
The Hypothesis of the Study: H1: Post-intervention (swaddling method) stress and cortisol levels of newborns on CPAP/noninvasive mechanical ventilator are lower than pre-intervention stress and cortisol levels.
Neonatal Stress Scale: The scale consists of 8 sub-dimensions (facial expression, body color, respiration, activity level, comfortability, muscle tone, extremities, posture), and 3-point Likert type. The items in the scale were graded according to the level of stress and grouped into 8 subgroups. In scoring, each subgroup is evaluated between 0-2 points. A minimum of 0 points and a maximum of 16 points are taken from the scale. The baby whose condition is stable and balanced will get a score of 0 from the scale. A high total score from the scale indicates that the baby's stress level is high.
- Conditions
- Nursing Caries, Newborn Illness, Nurse's Role
- Being tested
- nonpharmacologic intervention (swaddling)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nonpharmacologic intervention (swaddling)Other
Swaddling method;The newborn will be placed on a square fabric blanket in the flexion and abduction position and will be loosely swaddled with a blanket.
| Study group | Role | What they receive |
|---|---|---|
| Pretest | No intervention | Pretest: The newborn connected to nCPAP will be placed in the supine position and slight extension position on the neck of the newborn to ensure airway patency. The first saliva sample will be taken to measure cortisol level in the 30th minute after the first cry from the newborn who is connected to nasal CPAP. Immediately after the saliva sample is taken in pretest group, the stress level determined by using the "neonatal stress scale", vital signs (respiration, heart rate, oxygen saturation), saliva sample collection time will be recorded on the chart. |
| Posttest, swaddling | Experimental | Posttest: The swaddling method will be applied to the newborn after the first saliva sample is taken. A second saliva sample will be taken 30 minutes after swaddling to measure cortisol level. Immediately after the saliva sample is taken in posttest group, the stress level determined by using the "neonatal stress scale", vital signs, saliva sample collection time will be recorded on the chart. Receives: Other: nonpharmacologic intervention (swaddling) |
What is being measured
The primary outcome is the main question the study is designed to answer.
First inclusion criteria eligible 20 newborn will be add this study.
The saliva-specific Enzyme-Linked ImmunoSorbent Assay (ELISA) will be used for the study, for determine research results (pretest, posttest)
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start30 Dec 2022
- Primary completion28 Feb 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CariesStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The one-group, pretest, posttest research design.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657977
- Sponsor's protocol ID
- 1234
- Status last verified
- Sep 2022
- First submitted
- 1 Sep 2022
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Swaddling Method on Stress Level in Newborns Administration to Nasal CPAP
- ClinicalTrials.gov ID
- NCT05657977
- Acronym / sponsor ID
- 1234
- Conditions
- Nursing Caries, Newborn Illness, Nurse's Role
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 30 Dec 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 20 Dec 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.
Transient tachypnea of newborn (TTN) causes 42.5%-60% of non-infectious respiratory distress cases in newborns, it is seen in only 1% of all newborns. In the etiology of TTN, it results from the inability to effectively clear the fetal lung fluid immediately after birth. The most known risk factors of TTN are; prematurity, malpresentation, abnormal birth, premature rupture of the membrane, meconium aspiration, fetal distress, multiple pregnancy, male gender, and low Apgar score. TTN; It typically occurs in term and late preterm newborns within the first two hours of life. For the diagnosis of TTN, respiratory rate >60/min in the first 6-12 hours shows signs of groaning and retraction and improve spontaneously within a few days with 40% or less supportive oxygen therapy.
However, in some rare cases, prolongation of symptoms, noninvasive mechanical ventilation support [nasal continuous positive airway pressure (nCPAP), nonsynchronized nasal intermittent mandatory ventilation (NIMV)] and in some cases invasive (intubated) mechanical ventilation may be required.
Reducing pain and stress in mechanically ventilated infants is important for the prevention of complications that may occur in the future-early period and for recover process. While providing standard health care in the Neonatal Intensive Care Unit (NICU), sources of pain and stress should be identified and controlled. It is necessary to minimize the interventions that will cause pain and stress and to ensure that the newborn copes with the pain. In order to relieve pain and stress, various pharmacological (opioid, non-opioid analgesics) and non-pharmacological (breast milk, pacifier, kangaroo care, flexion posture, swaddling etc.) within the framework of family-centered care and individualized developmental care methods should be used. Pain control is a priority in neonatal nursing care, and it is the nurses; responsibility to select and implement a non-pharmacological intervention to reduce the level of pain. A limited number of studies have been found examining the effects of therapeutic touch and mothers voice on pain and comfort level in newborns, as a behavioral intervention, on relieving stress of body positioning in premature newborns who underwent nCPAP. There was no study found that the swaddling method applied during the procedure in patients followed up on nCPAP had an effect on reducing the stress level of newborns.
Detailed description
The aim of the proposed study is to determine the effect of the swaddling method applied to newborns in noninvasive mechanical ventilators on the stress level, by using the neonatal stress scale and salivary cortisol levels.
Type of the research: The research was planned to be conducted in a single group with a pre-test, post-test pattern experimental type.
Research variables Independent variable: Swaddling method. Dependent Variables: The stress felt by the newborn and the salivary cortisol level
The Hypothesis of the Study: H1: Post-intervention (swaddling method) stress and cortisol levels of newborns on CPAP/noninvasive mechanical ventilator are lower than pre-intervention stress and cortisol levels.
Neonatal Stress Scale: The scale consists of 8 sub-dimensions (facial expression, body color, respiration, activity level, comfortability, muscle tone, extremities, posture), and 3-point Likert type. The items in the scale were graded according to the level of stress and grouped into 8 subgroups. In scoring, each subgroup is evaluated between 0-2 points. A minimum of 0 points and a maximum of 16 points are taken from the scale. The baby whose condition is stable and balanced will get a score of 0 from the scale. A high total score from the scale indicates that the baby's stress level is high.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The one-group, pretest, posttest research design.
| Arm | Type | Receives |
|---|---|---|
| Pretest | No intervention | –Pretest: The newborn connected to nCPAP will be placed in the supine position and slight extension position on the neck of the newborn to ensure airway patency. The first saliva sample will be taken to measure cortisol level in the 30th minute after the first cry from the newborn who is connected to nasal CPAP. Immediately after the saliva sample is taken in pretest group, the stress level determined by using the "neonatal stress scale", vital signs (respiration, heart rate, oxygen saturation), saliva sample collection time will be recorded on the chart. |
| Posttest, swaddling | Experimental | Other: nonpharmacologic intervention (swaddling)Posttest: The swaddling method will be applied to the newborn after the first saliva sample is taken. A second saliva sample will be taken 30 minutes after swaddling to measure cortisol level. Immediately after the saliva sample is taken in posttest group, the stress level determined by using the "neonatal stress scale", vital signs, saliva sample collection time will be recorded on the chart. |
Who may qualify
- Ages
- 10 minutes to 5 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Birth week greater than 35 and birth weight greater than 2000 g,
- Need for nasal CPAP/noninvasive mechanical ventilator,
- Legal guardians' consent to participate in the research,
- Diagnosis of neonatal transient tachypnea after delivery.
Key exclusion criteria (19 listed)
- Taking cortisol-containing medication during the antenatal period
- Taking drugs during the antenatal period
- Being chorioamnionitis
- Metabolic disease (adrenal insufficiency, etc.)
- Amniotic fluid stained with meconium
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 |
|---|---|---|
| nonpharmacologic intervention (swaddling)Swaddling method;The newborn will be placed on a square fabric blanket in the flexion and abduction position and will be loosely swaddled with a blanket. | Other | Posttest, swaddling |
Primary outcome
First inclusion criteria eligible 20 newborn will be add this study.
Time frame: up to 2 months
The saliva-specific Enzyme-Linked ImmunoSorbent Assay (ELISA) will be used for the study, for determine research results (pretest, posttest)
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 12 Jul 2023.
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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 nonpharmacologic intervention (swaddling) in people with Nursing Caries and Newborn Illness, run by Kutahya Health Sciences 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 19 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 12 Jul 2023. 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?
First inclusion criteria eligible 20 newborn will be add this study. (time frame: up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.