MassageNCT06360159
Massage for Newborns Receiving Nasal CPAP
A study testing Intervention in people with Massage and Stress, run by Sultan Besiktas.
Trial summary
One of the most frequently required treatments for respiratory distress in neonatal intensive care is continuous positive airway pressure (NCPAP) support through the nose. NCPAP application has many advantages but also disadvantages and complications. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2024to 15 May 2026
- 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
- No healthy volunteers
- Child
Who may be able to join
- Gestational age greater than 34 weeks
- Birth weight of 2000 g and above,
- Within the first 24 hours of nasal CPAP application
- Fed at least one hour before the procedure,
- Having no congenital anomaly,
- Not having any disease at birth such as neonatal asphyxia, hemolytic condition, patent ductus arteriosus (PDA),
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- Those who have not undergone a surgical operation,
- The mother does not have alcohol, cigarette or other drug addiction,
- These are newborns to whom one of the parents (mother or father) has given verbal and written consent.
Who cannot join
- Rh and ABO incompatibility,
- APGAR score below 6,
- Analgesic or anesthetic medication is administered for sedation,
- Saliva sample cannot be taken,
- NEC developing,
- Leaving the hospital before the end of the working period,
Show all 9Show fewer
- Having had maternal obstetric complications,
- Receiving blood transfusion during the study,
- Newborns whose parents wish to withdraw from the study will not be accepted.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Massage on Stress, Comfort and Health Parameters of Newborns Receiving Nasal CPAP
One of the most frequently required treatments for respiratory distress in neonatal intensive care is continuous positive airway pressure (NCPAP) support through the nose. NCPAP application has many advantages but also disadvantages and complications.
Gastric-abdominal distension, which is a complication of NCPAP application, is caused by gas entering the stomach and gastrointestinal tract. Feeding intolerance may develop in the newborn due to abdominal distension. In recent studies, it has been determined that non-pharmacological methods and supportive developmental care practices used to increase the comfort and reduce pain and stress of babies who experience painful procedures such as NCPAP application and who are exposed to the stressful neonatal intensive care unit environment are effective in increasing comfort and reducing pain and stress. These practices include therapeutic touch, mother's voice, fetal position, white noise, lullaby, wrapping and massage. In the literature, a quasi-experimental study examining the effect of massage (Field massage technique) on the respiration, heart rate and oxygen saturation of 28-34 week old newborns with respiratory distress syndrome who received nasal CPAP showed that massage had no significant effect on oxygen saturation, but respiration and heart rate decreased after the massage. has been determined. There are studies in the literature examining the effects of therapeutic touch, mother's voice, fetal position, white noise, lullaby and wrapping in order to increase the comfort of newborns receiving nasal CPAP, reduce stress and pain, and prolong sleep time. However, no research has been found in the literature examining the effects of massage on the stress, comfort and health parameters of newborns receiving nasal CPAP.
Read the detailed description
Purpose of the research
This research was planned to determine the effect of massage on stress (behavioral-newborn stress scale and biological-salivary cortisol level), comfort (Newborn Comfort Behavior Scale) and health parameters (bilirubin level, amount of food intake, abdominal distension and defecation frequency) of newborns receiving nasal CPAP. .
Research Type: This research is a randomized controlled experimental study.
Population and sample/Study group
The population of the research will consist of newborn babies admitted to the Neonatal Intensive Care Unit of Erzincan Binali Yıldırım University Mengücek Gazi Training and Research Hospital. The research sample will consist of newborns who meet the research inclusion criteria. In the literature review, no study was found that evaluated the effect of massage on babies' stress (behavioral-newborn stress scale, biological-salivary cortisol level), comfort and health parameters (bilirubin level, food intake amount, abdominal distension and defecation frequency). Asmarani et al. (2020) in their study examining the effect of massage on salivary cortisol levels in premature newborns, it was determined that they reached 39 (19 intervention group, 20 control group) newborns (Asmarani et al., 2020). In this study, it was decided that the number of newborns in the groups would be 18, based on α = 95% confidence level and 80% power. The research sample will consist of 36 newborns (18 intervention group, 18 control group) who meet the research inclusion criteria.
Data collection tools
Newborn Information Form: Diagnosis of the newborn baby, gender, type of birth, height, birth weight, gestational and postnatal age, Apgar score, day of admission and discharge, time to start nasal CPAP application, total time of receiving nasal CPAP application, the status of receiving phototherapy treatment and the total number of hours of phototherapy treatment during the study will be recorded on this form.
Follow-up Form: The newborn baby's 3-day bilirubin level, defecation frequency, food intake amount, salivary cortisol level, abdominal circumference, stress and comfort scores will be recorded in this form during the study period.
Phototherapy Device: Okuman (Bilicare-BC 050 000) brand phototherapy device with blue LED technology will be used for phototherapy.
Digital Electronic Scale: NECK brand EBSH model baby scale (20 kg capacity - 5 g precision) will be used to measure the body weight of newborn babies.
Camera: A camera that can record, has high resolution, and has high optical focus will be used to evaluate the stress and comfort levels of babies in the intervention and control groups. The flash feature of the camera will not be used so that the baby is not disturbed by the camera light.
- Being tested
- Intervention
- Keywords
- massage, Stress, comfort, salivary cortisol level, nasal CPAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
As an intervention, the newborn will be massaged.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | INTERVENTION GROUP: For newborn babies in the massage group; Field massage protocol will be used and the massage will be applied by the assistant researcher. Field massage developed by Field et al. (1986); In a standardized 15-minute stimulation session, the stimulation technique is changed every 5 minutes, and it is applied 3 times a day as tactile stimulation in the first 5 minutes, kinesthetic stimulation in the second 5 minutes and tactile stimulation in the third 5 minutes.(tactile stimulation-kinesthetic stimulation-tactile stimulation) Receives: Other: Intervention |
| Control Group | No intervention | CONTROL GROUP: Apart from clinical routine practices, salivary cortisol samples will be taken from newborn babies in the control group and abdominal circumference of the babies will be measured. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress Level
Newborn Stress Scale: The newborn stress scale developed by Ceylan and Bolışık consists of a total of 24 items in a 3-point Likert type. The scale items include 8 subgroups including facial expression, body color, respiration, activity level, consolability, muscle tone, extremities and posture, and each subgroup is evaluated between 0-2 points in scoring. The minimum score from the scale is zero and the maximum score is 16. As the score increases, the baby's stress level increases.
Measured: Every day of the study for 3 days, the newborn's stress level will be evaluated 5 minutes before the first massage application and 5 minutes after the third massage application.
Salivary Cortisol Level
The newborn baby's saliva sample will be collected using the Salimetrics SalivaBio Infant's Swab (SIS). To collect a saliva sample, the swab will be held under the tongue and at the corners of the mouth for 60-90 seconds to obtain saliva and placed in the storage tube.
Measured: The newborn baby's salivary cortisol sample will be taken between 05-09 in the morning on the 1st and 4th days of the study.
Comfort Score
Newborn Comfort Behavior Scale: The newborn comfort behavior scale, whose validity and reliability was established by Kahraman, Başbakkal and Yalaz (2014), is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension and muscle tone. is the scale. Each item in the scale is scored from 1 to 5. It is evaluated based on the total score. The lowest score that can be obtained from the Newborn Comfort Behavior Scale is 6 and the highest score is 30. It is emphasized that if the total score of the scale is between 9-13, the baby is comfortable, if it is between 14-30, the baby is in pain or distress, the baby is uncomfortable and needs interventions to provide comfort.
Measured: Every day of the study for 3 days, the newborn's comfort level will be evaluated with the newborn comfort behavior scale 5 minutes before the first massage application and 5 minutes after the third massage application.
Bilirubin Level
Non-invasive bilirubin device: Non-invasive bilirubin device is a measuring device that measures babies' serum bilirubin non-invasively through the skin and has a measurement range of at least 0.0-20mg/dL. Bilirubin levels of newborns will be measured with this tool and recorded in the Monitoring Form.
Measured: Every day of the study for 3 days, the newborn baby's bilirubin level will be measured twice a day (before the first massage application and after the third massage application) with a non-invasive bilirubin device
Nutrient ıntake amount
Nutrient ıntake amount will be monitored on the daily nurse observation form.
Measured: It will be monitored every day of the study for 3 days.
Abdominal Circumference Measurement
Abdominal circumference will be measured with the same tape measure immediately before and after each massage application during the research.
Measured: Every day of the study for 3 days, abdominal circumference will be measured with the same tape measure.
Defecation Frequency
Defecation frequency will be monitored on the daily nurse observation form.
Measured: It will be monitored every day of the study for 3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study start15 Aug 2024 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion15 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MassageStudies 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
- Model description
- Intervention group (Massage): Babies in the intervention group will be massaged three times a day for 3 days, each session lasting 15 minutes, in accordance with the field massage technique. Massage application will be applied 1 hour after the babies are fed. For massage application, apply oil, solution and cream etc. to the baby's skin will not be used. During the massage application, the baby will be placed in prone and supine positions. Massage will be applied to the newborns in the intervention group by the assistant researcher. Control group: Apart from clinical routine practices, salivary cortisol samples will be taken from newborn babies in the control group and abdominal circumference of the babies will be measured.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sultan Besiktas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sultan Besiktas, TC Erciyes University
- Investigators
- Meral Bayat, Study director, TC Erciyes Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360159
- Sponsor's protocol ID
- Massage on Newborns
- Status last verified
- Jun 2024
- First submitted
- 15 Feb 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Massage on Stress, Comfort and Health Parameters of Newborns Receiving Nasal CPAP
- ClinicalTrials.gov ID
- NCT06360159
- Acronym / sponsor ID
- Massage on Newborns
- Keywords
- massage, Stress, comfort, salivary cortisol level, nasal CPAP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Sultan BesiktasUniversity, hospital or other
- Study start
- 15 Aug 2024 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 May 2026 (estimated)
- First posted
- 11 Apr 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.
One of the most frequently required treatments for respiratory distress in neonatal intensive care is continuous positive airway pressure (NCPAP) support through the nose. NCPAP application has many advantages but also disadvantages and complications.
Gastric-abdominal distension, which is a complication of NCPAP application, is caused by gas entering the stomach and gastrointestinal tract. Feeding intolerance may develop in the newborn due to abdominal distension. In recent studies, it has been determined that non-pharmacological methods and supportive developmental care practices used to increase the comfort and reduce pain and stress of babies who experience painful procedures such as NCPAP application and who are exposed to the stressful neonatal intensive care unit environment are effective in increasing comfort and reducing pain and stress. These practices include therapeutic touch, mother's voice, fetal position, white noise, lullaby, wrapping and massage. In the literature, a quasi-experimental study examining the effect of massage (Field massage technique) on the respiration, heart rate and oxygen saturation of 28-34 week old newborns with respiratory distress syndrome who received nasal CPAP showed that massage had no significant effect on oxygen saturation, but respiration and heart rate decreased after the massage. has been determined. There are studies in the literature examining the effects of therapeutic touch, mother's voice, fetal position, white noise, lullaby and wrapping in order to increase the comfort of newborns receiving nasal CPAP, reduce stress and pain, and prolong sleep time. However, no research has been found in the literature examining the effects of massage on the stress, comfort and health parameters of newborns receiving nasal CPAP.
Detailed description
Purpose of the research
This research was planned to determine the effect of massage on stress (behavioral-newborn stress scale and biological-salivary cortisol level), comfort (Newborn Comfort Behavior Scale) and health parameters (bilirubin level, amount of food intake, abdominal distension and defecation frequency) of newborns receiving nasal CPAP. .
Research Type: This research is a randomized controlled experimental study.
Population and sample/Study group
The population of the research will consist of newborn babies admitted to the Neonatal Intensive Care Unit of Erzincan Binali Yıldırım University Mengücek Gazi Training and Research Hospital. The research sample will consist of newborns who meet the research inclusion criteria. In the literature review, no study was found that evaluated the effect of massage on babies' stress (behavioral-newborn stress scale, biological-salivary cortisol level), comfort and health parameters (bilirubin level, food intake amount, abdominal distension and defecation frequency). Asmarani et al. (2020) in their study examining the effect of massage on salivary cortisol levels in premature newborns, it was determined that they reached 39 (19 intervention group, 20 control group) newborns (Asmarani et al., 2020). In this study, it was decided that the number of newborns in the groups would be 18, based on α = 95% confidence level and 80% power. The research sample will consist of 36 newborns (18 intervention group, 18 control group) who meet the research inclusion criteria.
Data collection tools
Newborn Information Form: Diagnosis of the newborn baby, gender, type of birth, height, birth weight, gestational and postnatal age, Apgar score, day of admission and discharge, time to start nasal CPAP application, total time of receiving nasal CPAP application, the status of receiving phototherapy treatment and the total number of hours of phototherapy treatment during the study will be recorded on this form.
Follow-up Form: The newborn baby's 3-day bilirubin level, defecation frequency, food intake amount, salivary cortisol level, abdominal circumference, stress and comfort scores will be recorded in this form during the study period.
Phototherapy Device: Okuman (Bilicare-BC 050 000) brand phototherapy device with blue LED technology will be used for phototherapy.
Digital Electronic Scale: NECK brand EBSH model baby scale (20 kg capacity - 5 g precision) will be used to measure the body weight of newborn babies.
Camera: A camera that can record, has high resolution, and has high optical focus will be used to evaluate the stress and comfort levels of babies in the intervention and control groups. The flash feature of the camera will not be used so that the baby is not disturbed by the camera light.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention group (Massage): Babies in the intervention group will be massaged three times a day for 3 days, each session lasting 15 minutes, in accordance with the field massage technique. Massage application will be applied 1 hour after the babies are fed. For massage application, apply oil, solution and cream etc. to the baby's skin will not be used. During the massage application, the baby will be placed in prone and supine positions. Massage will be applied to the newborns in the intervention group by the assistant researcher. Control group: Apart from clinical routine practices, salivary cortisol samples will be taken from newborn babies in the control group and abdominal circumference of the babies will be measured.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: InterventionINTERVENTION GROUP: For newborn babies in the massage group; Field massage protocol will be used and the massage will be applied by the assistant researcher. Field massage developed by Field et al. (1986); In a standardized 15-minute stimulation session, the stimulation technique is changed every 5 minutes, and it is applied 3 times a day as tactile stimulation in the first 5 minutes, kinesthetic stimulation in the second 5 minutes and tactile stimulation in the third 5 minutes.(tactile stimulation-kinesthetic stimulation-tactile stimulation) |
| Control Group | No intervention | –CONTROL GROUP: Apart from clinical routine practices, salivary cortisol samples will be taken from newborn babies in the control group and abdominal circumference of the babies will be measured. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Gestational age greater than 34 weeks
- Birth weight of 2000 g and above,
- Within the first 24 hours of nasal CPAP application
- Fed at least one hour before the procedure,
- Having no congenital anomaly,
Key exclusion criteria (9 listed)
- Rh and ABO incompatibility,
- APGAR score below 6,
- Analgesic or anesthetic medication is administered for sedation,
- Saliva sample cannot be taken,
- NEC developing,
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 |
|---|---|---|
| InterventionAs an intervention, the newborn will be massaged. | Other | Intervention Group |
Primary outcome
Stress Level
Time frame: Every day of the study for 3 days, the newborn's stress level will be evaluated 5 minutes before the first massage application and 5 minutes after the third massage application.
Newborn Stress Scale: The newborn stress scale developed by Ceylan and Bolışık consists of a total of 24 items in a 3-point Likert type. The scale items include 8 subgroups including facial expression, body color, respiration, activity level, consolability, muscle tone, extremities and posture, and each subgroup is evaluated between 0-2 points in scoring. The minimum score from the scale is zero and the maximum score is 16. As the score increases, the baby's stress level increases.
Salivary Cortisol Level
Time frame: The newborn baby's salivary cortisol sample will be taken between 05-09 in the morning on the 1st and 4th days of the study.
The newborn baby's saliva sample will be collected using the Salimetrics SalivaBio Infant's Swab (SIS). To collect a saliva sample, the swab will be held under the tongue and at the corners of the mouth for 60-90 seconds to obtain saliva and placed in the storage tube.
Comfort Score
Time frame: Every day of the study for 3 days, the newborn's comfort level will be evaluated with the newborn comfort behavior scale 5 minutes before the first massage application and 5 minutes after the third massage application.
Newborn Comfort Behavior Scale: The newborn comfort behavior scale, whose validity and reliability was established by Kahraman, Başbakkal and Yalaz (2014), is a Likert-type scale consisting of six parameters: alertness, calmness/agitation, respiratory response, crying, body movements, facial tension and muscle tone. is the scale. Each item in the scale is scored from 1 to 5. It is evaluated based on the total score. The lowest score that can be obtained from the Newborn Comfort Behavior Scale is 6 and the highest score is 30. It is emphasized that if the total score of the scale is between 9-13, the baby is comfortable, if it is between 14-30, the baby is in pain or distress, the baby is uncomfortable and needs interventions to provide comfort.
Bilirubin Level
Time frame: Every day of the study for 3 days, the newborn baby's bilirubin level will be measured twice a day (before the first massage application and after the third massage application) with a non-invasive bilirubin device
Non-invasive bilirubin device: Non-invasive bilirubin device is a measuring device that measures babies' serum bilirubin non-invasively through the skin and has a measurement range of at least 0.0-20mg/dL. Bilirubin levels of newborns will be measured with this tool and recorded in the Monitoring Form.
Nutrient ıntake amount
Time frame: It will be monitored every day of the study for 3 days.
Nutrient ıntake amount will be monitored on the daily nurse observation form.
Abdominal Circumference Measurement
Time frame: Every day of the study for 3 days, abdominal circumference will be measured with the same tape measure.
Abdominal circumference will be measured with the same tape measure immediately before and after each massage application during the research.
Defecation Frequency
Time frame: It will be monitored every day of the study for 3 days.
Defecation frequency will be monitored on the daily nurse observation form.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- 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.
Meral Bayat study director
TC Erciyes Universty
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Massage and Stress, run by Sultan Besiktas.
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 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Sultan Beşiktaş (04462122222, besiktas0724@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress Level (time frame: Every day of the study for 3 days, the newborn's stress level will be evaluated 5 minutes before the first massage application and 5 minutes after the third massage application.). The study lists 7 primary outcomes in all. 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 7 Jun 2024; AzTrials last refreshed its copy on 31 Oct 2026.