NewbornNCT04033874
The Efficacy of Non-pharmacological Interventions on Pain Levels, Crying Times and Voice Decibels in Newborns
A study testing kangaroo care, holding on the mother's lap and white noise listening in people with Newborn, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate and compare the effects of different non-pharmacological interventions (kangaroo care, holding on mother's lap, white noise listening, ambient sound listening) on newborns' crying times, voice decibels and pain levels during heel-stick procedure Read more about this study
- Who is it for?
- Ages 1 day to 5 daysHealthy volunteers can take part
- Conditions the study is for
- Newborn
- What is being tested?
- kangaroo care, holding on the mother's lap and white noise listening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jul 2019to Dec 2019
- 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 5 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Gestation age is between 34-42 weeks
- Birth weight is between 2500-4000 gr
- Apgar score of 1 minute and 5 minutes 8 and above
- Passing the newborn hearing screening test
- To being followed in the neonatal intensive care unit
- To being fed at least half an hour before the procedure
Show all 9Show fewer
- To being agreed to participate in the study by parents
- To being never received mechanical ventilation / CPAP support after birth
- Having none of congenital anomaly
Who cannot join
- Inability to take blood the first attempt, as the pain level may change
- Failure of the newborn to pass the hearing screening test
- Newborns hospitalized from polyclinic and emergency department because heel blood was taken before
- Refusing to participate in the study by parents
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Eskişehir Osmangazi University
Eskişehir, 26480
Pınar Duru, Ph.D., 90(222)2393750 ext. 1109, pinarduruu@hotmail.com
Özlem Örsal, Ph.D.
About this study
Official title: Comparison of the Efficacy of Non-pharmacological Interventions on Pain Levels, Crying Times and Voice Decibels in Newborns: A Randomized Controlled Trial
This study aimed to investigate and compare the effects of different non-pharmacological interventions (kangaroo care, holding on mother's lap, white noise listening, ambient sound listening) on newborns' crying times, voice decibels and pain levels during heel-stick procedure
Read the detailed description
The study is a prospective, randomized controlled trial including pre and post tests of four groups. The population of the study consisted of newborns who were followed in the Neonatal Service of Eskişehir City Hospital. The number of newborns to be sampled was determined by power analysis. With a 95% confidence interval, 0.25 effect size and 0.85 strength, 34 newborns are planned to be included in each group. Newborns who meet the inclusion criteria will be randomly assigned to the groups.
In the randomization process; in the four-group design, the rooms were randomly assigned to the study groups by drawing lots in order to eliminate the probability of influence of newborns from each other. Internal blinding was used as a blinding method in order to ensure complete randomization and to prevent Rosental effect. The randomization was performed by the responsible nurse of the unit who was unaware of the pre-test and post-tests of the application.
- Four different groups were formed in order to prevent the causes of concern in the randomization of patients who were leveled according to their clinical status in the neonatal intensive care unit.
- In the absence of neonatal intensive care environment noise, four groups were considered due to the limitation in explaining the benefit, contribution and effect of white noise, kangru care and being in the lap of the mother in reducing pain.
- The newborns treated with kangaroo care and the mother's lap will be the control groups of each other and the newborns treated with white noise and ambient sound will be the control groups of each other.
Research hypotheses:
H1. Newborns receiving kangaroo care during the heel-stick procedure have lower pain levels than newborns who are holding on their mother's lap.
H2. Newborns receiving kangaroo care during the heel-stick procedure have less crying time than newborns who are holding on their mother's lap.
H3. The highest level of sound decibels in the crying process of newborns who receiving kangaroo care during the heel-stick procedure are less than newborns who are holding on their mother's lap.
H4. Newborns listened to white noise during the heel-stick procedure have lower pain levels than newborns who listened to ambient sound.
H5. Newborns listened to white noise during the heel-stick procedure have less crying time than newborns who listened to ambient sound.
H6. The highest level of sound decibels in the crying process of newborns who listened to white noise during the heel-stick procedure are less than newborns listened to ambient sound.
In the study, NIPS (Neonatal Infant Pain Scale) will be used to evaluate the pain severity of newborns in addition to the data form prepared by the researchers.
During the application, pulse oximetry device will be placed on each newborn right wrist, then heart rate and SpO2 values will be recorded before, during and after the procedure. The device will remain attached to the baby's wrist during the procedure. Then, the pain level will be assessed with NIPS and heel-stick procedure will be initiated. To determine the crying time, the stopwatch shall be turned on and the sound decibel meter shall be turned on to determine the sound decibel. The general pain level of the newborns will be evaluated by one minute before the procedure and their response to the pain for three minutes during and after the procedure.
- Conditions
- Newborn
- Being tested
- kangaroo care, holding on the mother's lap, white noise listening, ambient sound listening
- Keywords
- Heel stick, Newborn, NIPS, Pain levels, Crying times, Voice decibels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kangaroo careOther
kangaroo care
holding on the mother's lapOther
holding on the mother's lap
white noise listeningOther
white noise listening
ambient sound listeningOther
ambient sound listening
| Study group | Role | What they receive |
|---|---|---|
| Kangaroo care | Experimental | Heel stick procedure will be performed during kangaroo care.
During the application, pulse oximetry device will be placed on each newborn right wrist, then heart rate and SpO2 values will be recorded before, during and after the procedure. The device will remain attached to the baby's wrist during the procedure. Then, the pain level will be assessed with NIPS (Neonatal Infant Pain Scale) and heel-stick procedure will be initiated. To determine the crying time, the stopwatch shall be turned on and the sound decibel meter shall be turned on to determine the sound decibel. The general pain level of the newborns will be evaluated by one minute before the procedure and their response to the pain for three minutes during and after the procedure. Receives: Other: kangaroo care |
| Mother's lap | Experimental | Heel stick procedure will be performed during newborns who are holding on their mother's lap.
During the application, pulse oximetry device will be placed on each newborn right wrist, then heart rate and SpO2 values will be recorded before, during and after the procedure. The device will remain attached to the baby's wrist during the procedure. Then, the pain level will be assessed with NIPS (Neonatal Infant Pain Scale) and heel-stick procedure will be initiated. To determine the crying time, the stopwatch shall be turned on and the sound decibel meter shall be turned on to determine the sound decibel. The general pain level of the newborns will be evaluated by one minute before the procedure and their response to the pain for three minutes during and after the procedure. Receives: Other: holding on the mother's lap |
| White noise | Experimental | Heel stick procedure will be performed during newborns listened to white noise.
For the white noise; the track named "do not cry your baby, pt. 2" will be played in Orhan Osman's Colic album. The white noise level will be adjusted to an average of 55 decibels. During the application, pulse oximetry device will be placed on each newborn right wrist, then heart rate and SpO2 values will be recorded before, during and after the procedure. The device will remain attached to the baby's wrist during the procedure. Then, the pain level will be assessed with NIPS (Neonatal Infant Pain Scale) and heel-stick procedure will be initiated. To determine the crying time, the stopwatch shall be turned on and the sound decibel meter shall be turned on to determine the sound decibel. The general pain level of the newborns will be evaluated by one minute before the procedure and their response to the pain for three minutes during and after the procedure. Receives: Other: white noise listening |
| Ambient sound | Experimental | Heel stick procedure will be performed during newborns listened to ambient sound.
During the application, pulse oximetry device will be placed on each newborn right wrist, then heart rate and SpO2 values will be recorded before, during and after the procedure. The device will remain attached to the baby's wrist during the procedure. Then, the pain level will be assessed with NIPS (Neonatal Infant Pain Scale) and heel-stick procedure will be initiated. To determine the crying time, the stopwatch shall be turned on and the sound decibel meter shall be turned on to determine the sound decibel. The general pain level of the newborns will be evaluated by one minute before the procedure and their response to the pain for three minutes during and after the procedure. Receives: Other: ambient sound listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crying times
Newborns' crying times during heel-stick procedure will be assessed with the stopwatch
Measured: Five months
Voice decibels
Newborns' voice decibels during heel-stick procedure will be assessed with the sound decibel meter
Measured: Five months
Pain levels
Newborns' pain levels during heel-stick procedure will be assessed with NIPS (Neonatal Infant Pain Scale)
Measured: Five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start10 Jul 2019
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
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 NewbornStudies 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
- The prospective, randomized controlled trial including pre and post tests of four groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Duru, Eskisehir Osmangazi University
- Investigators
- Özlem Örsal, Ph.D., Principal investigator, Eskişehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033874
- Sponsor's protocol ID
- Eskisehir Osmangazi University
- Status last verified
- Jul 2019
- First submitted
- 22 Jul 2019
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is planned to share the data of this study in December 2019
Publications
Gao H, Xu G, Gao H, Dong R, Fu H, Wang D, Zhang H, Zhang H. Effect of repeated Kangaroo Mother Care on repeated procedural pain in preterm infants: A randomized controlled trial. Int J Nurs Stud. 2015 Jul;52(7):1157-65. doi: 10.1016/j.ijnurstu.2015.04.006. Epub 2015 Apr 9.
PubMed 25912524Johnston C, Campbell-Yeo M, Disher T, Benoit B, Fernandes A, Streiner D, Inglis D, Zee R. Skin-to-skin care for procedural pain in neonates. Cochrane Database Syst Rev. 2017 Feb 16;2(2):CD008435. doi: 10.1002/14651858.CD008435.pub3.
PubMed 28205208Zhu J, Hong-Gu H, Zhou X, Wei H, Gao Y, Ye B, Liu Z, Chan SW. Pain relief effect of breast feeding and music therapy during heel lance for healthy-term neonates in China: a randomized controlled trial. Midwifery. 2015 Mar;31(3):365-72. doi: 10.1016/j.midw.2014.11.001. Epub 2014 Nov 11.
PubMed 25467598
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Non-pharmacological Interventions on Pain Levels, Crying Times and Voice Decibels in Newborns: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04033874
- Acronym / sponsor ID
- Eskisehir Osmangazi University
- Conditions
- Newborn
- Keywords
- Heel stick, Newborn, NIPS, Pain levels, Crying times, Voice decibels
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 26 Jul 2019 (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.
This study aimed to investigate and compare the effects of different non-pharmacological interventions (kangaroo care, holding on mother's lap, white noise listening, ambient sound listening) on newborns' crying times, voice decibels and pain levels during heel-stick procedure
Detailed description
The study is a prospective, randomized controlled trial including pre and post tests of four groups. The population of the study consisted of newborns who were followed in the Neonatal Service of Eskişehir City Hospital. The number of newborns to be sampled was determined by power analysis. With a 95% confidence interval, 0.25 effect size and 0.85 strength, 34 newborns are planned to be included in each group. Newborns who meet the inclusion criteria will be randomly assigned to the groups.
In the randomization process; in the four-group design, the rooms were randomly assigned to the study groups by drawing lots in order to eliminate the probability of influence of newborns from each other. Internal blinding was used as a blinding method in order to ensure complete randomization and to prevent Rosental effect. The randomization was performed by the responsible nurse of the unit who was unaware of the pre-test and post-tests of the application.
- Four different groups were formed in order to prevent the causes of concern in the randomization of patients who were leveled according to their clinical status in the neonatal intensive care unit.
- In the absence of neonatal intensive care environment noise, four groups were considered due to the limitation in explaining the benefit, contribution and effect of white noise, kangru care and being in the lap of the mother in reducing pain.
- The newborns treated with kangaroo care and the mother's lap will be the control groups of each other and the newborns treated with white noise and ambient sound will be the control groups of each other.
Research hypotheses:
H1. Newborns receiving kangaroo care during the heel-stick procedure have lower pain levels than newborns who are holding on their mother's lap.
H2. Newborns receiving kangaroo care during the heel-stick procedure have less crying time than newborns who are holding on their mother's lap.
H3. The highest level of sound decibels in the crying process of newborns who receiving kangaroo care during the heel-stick procedure are less than newborns who are holding on their mother's lap.
H4. Newborns listened to white noise during the heel-stick procedure have lower pain levels than newborns who listened to ambient sound.
H5. Newborns listened to white noise during the heel-stick procedure have less crying time than newborns who listened to ambient sound.
H6. The highest level of sound decibels in the crying process of newborns who listened to white noise during the heel-stick procedure are less than newborns listened to ambient sound.
In the study, NIPS (Neonatal Infant Pain Scale) will be used to evaluate the pain severity of newborns in addition to the data form prepared by the researchers.
During the application, pulse oximetry device will be placed on each newborn right wrist, then heart rate and SpO2 values will be recorded before, during and after the procedure. The device will remain attached to the baby's wrist during the procedure. Then, the pain level will be assessed with NIPS and heel-stick procedure will be initiated. To determine the crying time, the stopwatch shall be turned on and the sound decibel meter shall be turned on to determine the sound decibel. The general pain level of the newborns will be evaluated by one minute before the procedure and their response to the pain for three minutes during and after the procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The prospective, randomized controlled trial including pre and post tests of four groups
| Arm | Type | Receives |
|---|---|---|
| Kangaroo care | Experimental | Other: kangaroo careHeel stick procedure will be performed during kangaroo care. During the application, pulse oximetry device will be placed on each newborn right wrist, then heart rate and SpO2 values will be recorded before, during and after the procedure. The device will remain attached to the baby's wrist during the procedure. Then, the pain level will be assessed with NIPS (Neonatal Infant Pain Scale) and heel-stick procedure will be initiated. To determine the crying time, the stopwatch shall be turned on and the sound decibel meter shall be turned on to determine the sound decibel. The general pain level of the newborns will be evaluated by one minute before the procedure and their response to the pain for three minutes during and after the procedure. |
| Mother's lap | Experimental | Other: holding on the mother's lapHeel stick procedure will be performed during newborns who are holding on their mother's lap. During the application, pulse oximetry device will be placed on each newborn right wrist, then heart rate and SpO2 values will be recorded before, during and after the procedure. The device will remain attached to the baby's wrist during the procedure. Then, the pain level will be assessed with NIPS (Neonatal Infant Pain Scale) and heel-stick procedure will be initiated. To determine the crying time, the stopwatch shall be turned on and the sound decibel meter shall be turned on to determine the sound decibel. The general pain level of the newborns will be evaluated by one minute before the procedure and their response to the pain for three minutes during and after the procedure. |
| White noise | Experimental | Other: white noise listeningHeel stick procedure will be performed during newborns listened to white noise. For the white noise; the track named "do not cry your baby, pt. 2" will be played in Orhan Osman's Colic album. The white noise level will be adjusted to an average of 55 decibels. During the application, pulse oximetry device will be placed on each newborn right wrist, then heart rate and SpO2 values will be recorded before, during and after the procedure. The device will remain attached to the baby's wrist during the procedure. Then, the pain level will be assessed with NIPS (Neonatal Infant Pain Scale) and heel-stick procedure will be initiated. To determine the crying time, the stopwatch shall be turned on and the sound decibel meter shall be turned on to determine the sound decibel. The general pain level of the newborns will be evaluated by one minute before the procedure and their response to the pain for three minutes during and after the procedure. |
| Ambient sound | Experimental | Other: ambient sound listeningHeel stick procedure will be performed during newborns listened to ambient sound. During the application, pulse oximetry device will be placed on each newborn right wrist, then heart rate and SpO2 values will be recorded before, during and after the procedure. The device will remain attached to the baby's wrist during the procedure. Then, the pain level will be assessed with NIPS (Neonatal Infant Pain Scale) and heel-stick procedure will be initiated. To determine the crying time, the stopwatch shall be turned on and the sound decibel meter shall be turned on to determine the sound decibel. The general pain level of the newborns will be evaluated by one minute before the procedure and their response to the pain for three minutes during and after the procedure. |
Who may qualify
- Ages
- 1 day to 5 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Gestation age is between 34-42 weeks
- Birth weight is between 2500-4000 gr
- Apgar score of 1 minute and 5 minutes 8 and above
- Passing the newborn hearing screening test
- To being followed in the neonatal intensive care unit
Key exclusion criteria (4 listed)
- Inability to take blood the first attempt, as the pain level may change
- Failure of the newborn to pass the hearing screening test
- Newborns hospitalized from polyclinic and emergency department because heel blood was taken before
- Refusing to participate in the study by parents
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 |
|---|---|---|
| kangaroo carekangaroo care | Other | Kangaroo care |
| holding on the mother's lapholding on the mother's lap | Other | Mother's lap |
| white noise listeningwhite noise listening | Other | White noise |
| ambient sound listeningambient sound listening | Other | Ambient sound |
Primary outcome
Crying times
Time frame: Five months
Newborns' crying times during heel-stick procedure will be assessed with the stopwatch
Voice decibels
Time frame: Five months
Newborns' voice decibels during heel-stick procedure will be assessed with the sound decibel meter
Pain levels
Time frame: Five months
Newborns' pain levels during heel-stick procedure will be assessed with NIPS (Neonatal Infant Pain Scale)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Results publication: PubMed 25912524Gao H, Xu G, Gao H, Dong R, Fu H, Wang D, Zhang H, Zhang H. Effect of repeated Kangaroo Mother Care on repeated procedural pain in preterm infants: A randomized controlled trial. Int J Nurs Stud. 2015 Jul;52(7):1157-65. doi: 10.1016/j.ijnurstu.2015.04.006. Epub 2015 Apr 9.
- Results publication: PubMed 28205208Johnston C, Campbell-Yeo M, Disher T, Benoit B, Fernandes A, Streiner D, Inglis D, Zee R. Skin-to-skin care for procedural pain in neonates. Cochrane Database Syst Rev. 2017 Feb 16;2(2):CD008435. doi: 10.1002/14651858.CD008435.pub3.
- Results publication: PubMed 25467598Zhu J, Hong-Gu H, Zhou X, Wei H, Gao Y, Ye B, Liu Z, Chan SW. Pain relief effect of breast feeding and music therapy during heel lance for healthy-term neonates in China: a randomized controlled trial. Midwifery. 2015 Mar;31(3):365-72. doi: 10.1016/j.midw.2014.11.001. Epub 2014 Nov 11.
- Individual participant dataSharing planned: No. It is planned to share the data of this study in December 2019
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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.
Özlem Örsal, Ph.D. principal investigator
Eskişehir Osmangazi 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 kangaroo care, holding on the mother's lap and white noise listening in people with Newborn, run by Eskisehir Osmangazi 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 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pınar Duru, Ph.D (+90(222)2393750 ext. 1109, pinarduruu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Crying times (time frame: Five months). The study lists 3 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 NCT04033874, 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 26 Jul 2019.