NewbornsNewbornNCT06387888
The Effect of Mother's Voice on the Levels of Pain and Comfort in Newborns
A study testing Listening to mother's voice in people with Newborns, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted in a randomized controlled experimental type to determine the effect of maternal voice during care on pain and comfort level in term newborns receiving mechanical ventilation. Read more about this study
- Who is it for?
- Ages 3 to 41 weeksHealthy volunteers can take part
- Conditions the study is for
- Newborns
- What is being tested?
- Listening to mother's voice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 30 Apr 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 3 to 41 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Connected to a mechanical ventilator (intubation or nasal CPAP),
- Term newborns (born at 37-42 weeks),
- No neurological disorders,
- No congenital or acquired hearing malformations,
- The family consents for their infant to participate in the study,
Who cannot join
- Diagnosis of asphyxia,
- Use of sedatives or analgesics,
- Congenital anomaly,
- Underwent an extra invasive procedure or surgical intervention,
- Parents with congenital hearing problems.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Hospital
Istanbul, Beykoz
About this study
Official title: The Effect of Mother's Voice on the Levels of Pain and Comfort in Newborns on Mechanical Ventilation: a Randomized Controlled Study
This study was conducted in a randomized controlled experimental type to determine the effect of maternal voice during care on pain and comfort level in term newborns receiving mechanical ventilation. The sample of the study was consisted of 60 term newborns receiving mechanical ventilation who were hospitalized in the 7-bed Neonatal Intensive Care Unit of a private hospital in Istanbul in accordance with the selection criteria. Introductory Information Form, Vital Signs Follow-up Form, Neonatal Comfort Behavior Scale and Neonatal Pain Scale (NPASS) forms prepared by the researchers were used as data collection tools.
Read the detailed description
Intervention group: During the care, from the beginning to the end, mother's voice was played to the newborns. It took about 20 minutes. The mini Bluetooth speaker and the decibel meter were disinfected with the rapid surface disinfectant used in the clinic. The speaker was placed 30 cm away from the infant's ear and the sound level in the incubator was adjusted to be 50-60 dB by using a decibel meter Mother's voice was played from the beginning of the provision of care and continued for 15 minutes after the end of the provision of care. During the provision of care, COMFORTneo scores, pain scores, and vital signs were measured and recorded on the vital signs follow-up form.
Control group: Standard nursing care lasting 20 minutes was performed in the routine sound environment of the neonatal intensive care unit. COMFORTneo scores, pain scores, and vital signs were measured and recorded on the vital signs follow-up form.
- Conditions
- Newborns
- Being tested
- Listening to mother's voice
- Keywords
- Comfort,, Mechanical ventilatör,, Mother's voice,, Newborn,, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Listening to mother's voiceOther
During the care, from the beginning to the end, mother's voice was played to the newborns. It took about 20 minutes. The mini Bluetooth speaker and the decibel meter were disinfected with the rapid surface disinfectant used in the clinic. The speaker was placed 30 cm away from the infant's ear and the sound level in the incubator was adjusted to be 50-60 dB by using a decibel meter (Official Gazette, 2018). Mother's voice was played from the beginning of the provision of care and continued for 15 minutes after the end of the provision of care. During the provision of care, COMFORTneo scores, pain scores, and vital signs were measured and recorded on the vital signs follow-up form.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group-30 | Experimental | During the care, from the beginning to the end, mother's voice was played to the newborns. It took about 20 minutes. The mini Bluetooth speaker and the decibel meter were disinfected with the rapid surface disinfectant used in the clinic. The speaker was placed 30 cm away from the infant's ear and the sound level in the incubator was adjusted to be 50-60 dB by using a decibel meter. Mother's voice was played from the beginning of the provision of care and continued for 15 minutes after the end of the provision of care. During the provision of care, COMFORTneo scores, pain scores, and vital signs were measured and recorded on the vital signs follow-up form. Receives: Other: Listening to mother's voice |
| Control group-30 | No intervention | Standard nursing care lasting 20 minutes was performed in the routine sound environment of the neonatal intensive care unit. COMFORTneo scores, pain scores, and vital signs were measured and recorded on the vital signs follow-up form. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Comfort Behavior Scale
The scale is for 0-100-day-old infants and term or preterm newborns experiencing acute or chronic pain and treated with or without mechanical ventilation.
Measured: 20 minutes
Secondary outcomes (1)
Neonatal Comfort Behavior Scale (COMFORTneo):
COMFORTneo consists of 7 items on alertness, calmness/agitation, respiratory response, crying, body movement, facial tension, and muscle tone. Of these items, "respiratory response" is evaluated in newborns on mechanical ventilation and "crying" is evaluated in spontaneously breathing newborns.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Jul 2021
- Primary completion1 Sep 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NewbornsStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aysel kokcudogan, Istanbul Medipol University Hospital
- Investigators
- Aysel Kökcü Doğan, Study director, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387888
- Sponsor's protocol ID
- E-31034136-302.08.01-4221
- Acronym
- Newborn
- Status last verified
- Apr 2024
- First submitted
- 20 Apr 2024
- Last updated
- 29 Apr 2024
- 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 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mother's Voice on the Levels of Pain and Comfort in Newborns on Mechanical Ventilation: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06387888
- Acronym / sponsor ID
- Newborn / E-31034136-302.08.01-4221
- Conditions
- Newborns
- Keywords
- Comfort,, Mechanical ventilatör,, Mother's voice,, Newborn,, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 29 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.
This study was conducted in a randomized controlled experimental type to determine the effect of maternal voice during care on pain and comfort level in term newborns receiving mechanical ventilation. The sample of the study was consisted of 60 term newborns receiving mechanical ventilation who were hospitalized in the 7-bed Neonatal Intensive Care Unit of a private hospital in Istanbul in accordance with the selection criteria. Introductory Information Form, Vital Signs Follow-up Form, Neonatal Comfort Behavior Scale and Neonatal Pain Scale (NPASS) forms prepared by the researchers were used as data collection tools.
Detailed description
Intervention group: During the care, from the beginning to the end, mother's voice was played to the newborns. It took about 20 minutes. The mini Bluetooth speaker and the decibel meter were disinfected with the rapid surface disinfectant used in the clinic. The speaker was placed 30 cm away from the infant's ear and the sound level in the incubator was adjusted to be 50-60 dB by using a decibel meter Mother's voice was played from the beginning of the provision of care and continued for 15 minutes after the end of the provision of care. During the provision of care, COMFORTneo scores, pain scores, and vital signs were measured and recorded on the vital signs follow-up form.
Control group: Standard nursing care lasting 20 minutes was performed in the routine sound environment of the neonatal intensive care unit. COMFORTneo scores, pain scores, and vital signs were measured and recorded on the vital signs follow-up form.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group-30 | Experimental | Other: Listening to mother's voiceDuring the care, from the beginning to the end, mother's voice was played to the newborns. It took about 20 minutes. The mini Bluetooth speaker and the decibel meter were disinfected with the rapid surface disinfectant used in the clinic. The speaker was placed 30 cm away from the infant's ear and the sound level in the incubator was adjusted to be 50-60 dB by using a decibel meter. Mother's voice was played from the beginning of the provision of care and continued for 15 minutes after the end of the provision of care. During the provision of care, COMFORTneo scores, pain scores, and vital signs were measured and recorded on the vital signs follow-up form. |
| Control group-30 | No intervention | –Standard nursing care lasting 20 minutes was performed in the routine sound environment of the neonatal intensive care unit. COMFORTneo scores, pain scores, and vital signs were measured and recorded on the vital signs follow-up form. |
Who may qualify
- Ages
- 3 to 41 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Connected to a mechanical ventilator (intubation or nasal CPAP),
- Term newborns (born at 37-42 weeks),
- No neurological disorders,
- No congenital or acquired hearing malformations,
- The family consents for their infant to participate in the study,
Key exclusion criteria (5 listed)
- Diagnosis of asphyxia,
- Use of sedatives or analgesics,
- Congenital anomaly,
- Underwent an extra invasive procedure or surgical intervention,
- Parents with congenital hearing problems.
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 |
|---|---|---|
| Listening to mother's voiceDuring the care, from the beginning to the end, mother's voice was played to the newborns. It took about 20 minutes. The mini Bluetooth speaker and the decibel meter were disinfected with the rapid surface disinfectant used in the clinic. The speaker was placed 30 cm away from the infant's ear and the sound level in the incubator was adjusted to be 50-60 dB by using a decibel meter (Official Gazette, 2018). Mother's voice was played from the beginning of the provision of care and continued for 15 minutes after the end of the provision of care. During the provision of care, COMFORTneo scores, pain scores, and vital signs were measured and recorded on the vital signs follow-up form. | Other | Intervention group-30 |
Primary outcome
Neonatal Comfort Behavior Scale
Time frame: 20 minutes
The scale is for 0-100-day-old infants and term or preterm newborns experiencing acute or chronic pain and treated with or without mechanical ventilation.
1 secondary outcome
Neonatal Comfort Behavior Scale (COMFORTneo):
Time frame: 20 minutes
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 29 Apr 2024.
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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.
Aysel Kökcü Doğan study director
Istanbul Medipol University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Listening to mother's voice in people with Newborns, run by Istanbul Medipol University Hospital 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 5 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 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Neonatal Comfort Behavior Scale (time frame: 20 minutes). 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 29 Apr 2024.