PainNCT05578079
The Effectiveness of Music on Pain During Heel Blood Collection in Premature Infants
A study testing Music in people with Pain, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).
Trial summary
Premature babies receiving treatment and care in the Neonatal Intensive Care Unit (NICU) are exposed to various painful procedures. Repetitive and untreated painful procedures have a negative impact on the physiological, cognitive and behavioral development of the baby. Read more about this study
- Who is it for?
- Ages 32 to 37 weeks
- Conditions the study is for
- Pain
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Oct 2022to 25 Apr 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 32 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parent being voluntary to participate in the study
- Being born at 32-36+6 gestastional week
- The baby's condition is stable
- Having passed hearing test
- Having not congenital malformation
Who cannot join
- Birth weight below 2500 g
- Receiving analgesics or sedatives
- Need for mechanical ventilation
- Heel blood collection is not successful in the first time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Music on Pain During Heel Blood Collection in Premature Infants: A Double-Blind Randomized Controlled Trial
Premature babies receiving treatment and care in the Neonatal Intensive Care Unit (NICU) are exposed to various painful procedures. Repetitive and untreated painful procedures have a negative impact on the physiological, cognitive and behavioral development of the baby.
Various approaches such as white noise, music, lullaby, kangaroo care, breastfeeding, swaddling, massage, and therapeutic positioning are used to reduce the painful processes that newborns are exposed to in the NICU.
Read the detailed description
Premature babies receiving treatment and care in the Neonatal Intensive Care Unit (NICU) are exposed to various painful procedures. Repetitive and untreated painful procedures have a negative impact on the physiological, cognitive and behavioral development of the baby.
Various approaches such as white noise, music, lullaby, kangaroo care, breastfeeding, swaddling, massage, and therapeutic positioning are used to reduce the painful processes that newborns are exposed to in the NICU.
- Conditions
- Pain
- Being tested
- Music
- Keywords
- Premature, Pain, Music
- Medical subject headings
- Pain, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Intervention-1 group will listen to the classical music that the "Arts of Fugue" by Bach.
MusicOther
Intervention-2 group will listen to lullaby.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No music will be played to the control group. |
| Intervention 1 | Active comparator | The Intervention-1 group will listen to the music which determined by the researchers by examining the literature (DOI: 10.4274/jpr.24892). The music which determined by the researchers is "The art of fugue" by Johann Sebastian Bach. Receives: Other: Music |
| Intervention 2 | Active comparator | The Intervention-2 group will listen to lullaby. Receives: Other: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baby's heart rate
The baby's pulse rate will be measured.
Measured: 2 minutes before collecting heel blood
Baby's heart rate
The baby's pulse rate will be measured.
Measured: During heel blood collection
Baby's heart rate
The baby's pulse rate will be measured.
Measured: 2 minutes after collecting heel blood
Baby's respiratory rate
The baby's respiratory rate will be measured.
Measured: 2 minutes before collecting heel blood
Baby's respiratory rate
The baby's respiratory rate will be measured.
Measured: During heel blood collection
Baby's respiratory rate
The baby's respiratory rate will be measured.
Measured: 2 minutes after collecting heel blood
Baby's oxygen saturation
The baby's oxygen saturation will be measured.
Measured: 2 minutes before collecting heel blood
Baby's oxygen saturation
The baby's oxygen saturation will be measured.
Measured: During heel blood collection
Baby's oxygen saturation
The baby's oxygen saturation will be measured.
Measured: 2 minutes after collecting heel blood
Premature Infant Pain Profile (PIPP)
PIPP scores will be evaluated separately by two experts in the field.
Measured: 2 minutes before collecting heel blood
Premature Infant Pain Profile (PIPP)
PIPP scores will be evaluated separately by two experts in the field.
Measured: During heel blood collection
Premature Infant Pain Profile (PIPP)
PIPP scores will be evaluated separately by two experts in the field.
Measured: 2 minutes after collecting heel blood
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start14 Oct 2022
- Primary completion25 Apr 2023
- Study completion25 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Katip Celebi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Dogan, Izmir Katip Celebi University
- Investigators
- Defne ENGUR, Assoc.Prof., Study chair, Tepecik Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578079
- Sponsor's protocol ID
- 05
- Status last verified
- Jul 2023
- First submitted
- 10 Oct 2022
- Last updated
- 24 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 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Music on Pain During Heel Blood Collection in Premature Infants: A Double-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05578079
- Acronym / sponsor ID
- 05
- Conditions
- Pain
- Keywords
- Premature, Pain, Music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Izmir Katip Celebi UniversityUniversity, hospital or other
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 13 Oct 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.
Premature babies receiving treatment and care in the Neonatal Intensive Care Unit (NICU) are exposed to various painful procedures. Repetitive and untreated painful procedures have a negative impact on the physiological, cognitive and behavioral development of the baby.
Various approaches such as white noise, music, lullaby, kangaroo care, breastfeeding, swaddling, massage, and therapeutic positioning are used to reduce the painful processes that newborns are exposed to in the NICU.
Detailed description
Premature babies receiving treatment and care in the Neonatal Intensive Care Unit (NICU) are exposed to various painful procedures. Repetitive and untreated painful procedures have a negative impact on the physiological, cognitive and behavioral development of the baby.
Various approaches such as white noise, music, lullaby, kangaroo care, breastfeeding, swaddling, massage, and therapeutic positioning are used to reduce the painful processes that newborns are exposed to in the NICU.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No music will be played to the control group. |
| Intervention 1 | Active comparator | Other: MusicThe Intervention-1 group will listen to the music which determined by the researchers by examining the literature (DOI: 10.4274/jpr.24892). The music which determined by the researchers is "The art of fugue" by Johann Sebastian Bach. |
| Intervention 2 | Active comparator | Other: MusicThe Intervention-2 group will listen to lullaby. |
Who may qualify
- Ages
- 32 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Parent being voluntary to participate in the study
- Being born at 32-36+6 gestastional week
- The baby's condition is stable
- Having passed hearing test
- Having not congenital malformation
Key exclusion criteria (4 listed)
- Birth weight below 2500 g
- Receiving analgesics or sedatives
- Need for mechanical ventilation
- Heel blood collection is not successful in the first time
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 |
|---|---|---|
| MusicIntervention-1 group will listen to the classical music that the "Arts of Fugue" by Bach. | Other | Intervention 1 |
| MusicIntervention-2 group will listen to lullaby. | Other | Intervention 2 |
Primary outcome
Baby's heart rate
Time frame: 2 minutes before collecting heel blood
The baby's pulse rate will be measured.
Baby's heart rate
Time frame: During heel blood collection
The baby's pulse rate will be measured.
Baby's heart rate
Time frame: 2 minutes after collecting heel blood
The baby's pulse rate will be measured.
Baby's respiratory rate
Time frame: 2 minutes before collecting heel blood
The baby's respiratory rate will be measured.
Baby's respiratory rate
Time frame: During heel blood collection
The baby's respiratory rate will be measured.
Baby's respiratory rate
Time frame: 2 minutes after collecting heel blood
The baby's respiratory rate will be measured.
Baby's oxygen saturation
Time frame: 2 minutes before collecting heel blood
The baby's oxygen saturation will be measured.
Baby's oxygen saturation
Time frame: During heel blood collection
The baby's oxygen saturation will be measured.
Baby's oxygen saturation
Time frame: 2 minutes after collecting heel blood
The baby's oxygen saturation will be measured.
Premature Infant Pain Profile (PIPP)
Time frame: 2 minutes before collecting heel blood
PIPP scores will be evaluated separately by two experts in the field.
Premature Infant Pain Profile (PIPP)
Time frame: During heel blood collection
PIPP scores will be evaluated separately by two experts in the field.
Premature Infant Pain Profile (PIPP)
Time frame: 2 minutes after collecting heel blood
PIPP scores will be evaluated separately by two experts in the field.
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 24 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.
Defne ENGUR, Assoc.Prof. study chair
Tepecik Research and Training 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 Music in people with Pain, run by Izmir Katip Celebi 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 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: finished, as of the sponsor's last update on 24 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?
Baby's heart rate (time frame: 2 minutes before collecting heel blood). The study lists 12 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 24 Jul 2023.