Pain, AcuteNCT06279169
The Effect of Heart Sound and White Noise on Pain and Physiological Parameters During Hepatitis B Vaccine Injection
A study testing Heart Sound and White Noise in people with Pain, Acute and Newborn; Vitality, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
Trial summary
It can cause physiological and behavioral changes in infants such as pain, tachycardia, hypoxemia, increased blood pressure, grimacing, prolonged crying, and irritability. Vaccination is an important part of neonatal nursing care. Newborns express their pain nonverbally and behaviorally. Read more about this study
- Who is it for?
- Ages 2 to 28 days
- Conditions the study is for
- Pain, Acute, Newborn; Vitality
- What is being tested?
- Heart Sound and White Noise
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Apr 2024to 29 Aug 2025
- 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 2 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age of 38-41 weeks,
- Newborn birth weight >2500 g
- Stable vital signs before the procedure,
- Postanatal age between 2-28 days,
- No contraindications to the administration of hepatitis B vaccine
- Delivery of the newborn to the mother after birth
Show all 10Show fewer
- Consent of the parents of the newborn to participate in the study
- Fasting less than 3 hours/30 minutes before feeding
- A valid score on the newborn hearing screening test
- Newborn not crying before vaccination
Who cannot join
- Newborn babies requiring respiratory support,
- Newborns with any neurological disorder (seizures)
- Newborns taking opiates or born to mothers taking opiates
- Newborns receiving muscle relaxants, sedatives, analgesics
- Babies with major congenital anomalies
- Neonates with an APGAR score of less than 7 at 5 minutes
Show all 11Show fewer
- Neonates who have undergone surgery
- Newborns with birth trauma (especially rapid delivery)
- Conditions that may prevent communication with parents (e.g. speech problem)
- Hearing impairment
- Newborns who will be transferred to another hospital
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bartın University
Bartın
Fatma Dinç, Asst.Prof., +9005383555685, fatmadinc@bartin.edu.tr
Aylin Kurt, Asst.Prof., +9005382087211, aylinkurt67@gmail.com
About this study
Official title: The Effect of Heart Sound and White Noise on Pain and Physiological Parameters During Hepatitis B Vaccine Injection in Newborns: A Randomized Controlled Trial
It can cause physiological and behavioral changes in infants such as pain, tachycardia, hypoxemia, increased blood pressure, grimacing, prolonged crying, and irritability. Vaccination is an important part of neonatal nursing care. Newborns express their pain nonverbally and behaviorally. Therefore, any pain assessment is based on the ability of others to recognize pain symptoms. This randomized controlled trial was planned to evaluate the effect of heart sound and white noise on pain and physiological parameters during intramuscular injection of hepatitis B vaccine in newborns. This randomized controlled study used parallel trial design.
Read the detailed description
The research hypotheses are H1: Neonates in the heart sound group will have lower procedural pain scores than neonates in the control group. H2: Neonates in the white noise group will have lower procedural pain scores than neonates in the control group. H3: Neonates in the heart sound group have lower procedural heart rate peak values than neonates in the control group. H4: Neonates in the white noise group have lower procedure-related peak heart rates than neonates in the control group. H5: Neonates in the heart sound group have higher procedural oxygen saturation values than neonates in the control group. H6: Neonates in the white noise group have higher procedural oxygen saturation values than neonates in the control group.
Methods The study was designed as a randomized controlled trial. The population of this study will consist of newborns who are followed up at Bartın Maternity and Children's Hospital. Statistical power, type I error, effect size, and study design will be taken into account when calculating the sample size. The study will be designed to have a power of at least 80% and a type I error rate of 5%. As there is no similar study evaluating the effect of heart tones and white noise on pain and physiological parameters during hepatitis B vaccination in children, the effect size of the study will be aimed at medium (0.25) to determine the sample size. Based on a medium effect size (f: 0.25), 80% (1 - β error) power and 95% (α error) confidence level, and taking into account data loss, it was calculated that the sample size should be increased by 10%, and the sample size of 33 newborns in each group should consist of 99 newborns in total G*Power 3.1.9.7.
Before starting the study, mothers will be informed about the purpose of the study and the heart sound and white noise applications to be applied and their written informed consent will be obtained. After written informed consent has been obtained from the mothers, the newborns will be randomised to 3 groups (heart sound, white noise, control group) by a statistician independent of the study (www. randomize.org) using a computer program. All newborns will receive a standardised approach. Standardised approach: All Hep B vaccine administration will be performed by a nurse during the morning shift and administered intramuscularly through the vastus lateralis muscle at a 90-degree angle using a 1-inch 23-gauge needle to infants in all three groups. All conditions such as room temperature (25°C), light, injection procedure will be the same in all three groups. Neonates will be fed at least 30 minutes before the procedure. Care will be taken to avoid non-nutritive sucking, touching or swaddling the baby during the procedure to avoid confusion with other pain relief methods. Aseptic techniques are observed during all procedures.
During the implementation of the measurement tools, the researcher will go to the relevant facility herself and the data collection forms will be applied face to face. The researcher and the nurse will not use any aromatic substances in the baby monitoring room during the study.
- Conditions
- Pain, Acute, Newborn; Vitality
- Being tested
- Heart Sound, White Noise
- Keywords
- Pain, Acute Pain
- Medical subject headings
- Acute Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart SoundBehavioural
In the Heart sound group, this sound will be played to the newborn 5 minutes before Hep B vaccine administration, during the procedure (at 1 minute) and 5 minutes after Hep B vaccine administration
White NoiseBehavioural
Musician Osman Orhan's song "Bebeğiniz Ağlamasın" from his album Kolik will be used for white noise. The volume will be set to 45 db.
| Study group | Role | What they receive |
|---|---|---|
| Heart sound group | Experimental | In the heart sound group, the heart sound with an average heart rate of 70 beats is transmitted to the loudspeaker via an Mp3 player. Two small 200 W loudspeakers (SONY®)/"JBL" brand loudspeakers are used, placed on either side of the newborn's head, 30 cm from the newborn's ears. Receives: Behavioral: Heart Sound |
| White noise group | Experimental | In the white noise group, the mother of the baby is told that the white noise to be used in the study will be used for pain relief. For the white noise, the musician Osman Orhan's colic album, which was released by the production and often used in the literature. The song "Bebeğiniz Ağlamasın Pt-3" from the album "Kolik" will be used (permission to use it in this work has been granted by ON Music Production). The volume is set to 45 db. The "JBL" loudspeaker is placed on the newborn's toe 5 minutes before the procedure, about 30 cm from the newborn's ear, and white noise is played 5 minutes before, during (at the 1st minute) and 5 minutes after the administration of the Hep B vaccine. Receives: Behavioral: White Noise |
| Control | No intervention | Newborns in the control group will not receive any intervention other than Hepatitis B vaccination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Newborn Infant Pain Scale (NIPS)
Used to assess behavioral and physiological pain responses of preterm and term infants. The Neonatal Infant Pain Scale is a Likert-type scale consisting of 6 parameters including facial movements (0; relaxed, 1; restless), crying (0; no crying, 1; moaning, 2; loud crying), breathing (0; relaxed, 1; variable-irregular), arm (0; relaxed-free, 1; flexion-extension), leg (0; relaxed-free, 1; flexion-extension) and sleep-wakefulness (0; sleep-wakefulness peaceful, 1; restless). According to the scale, 7 is interpreted as the highest level of pain and 0 as the lowest level of pain. A high score indicates greater severity of pain.
Measured: 15 minutes
Secondary outcomes (3)
oxygen saturation
In each group, oxygen saturation of the newborns to be included in the study will be performed by the same researcher with the same calibrated pulseoximeter device in the infant monitoring unit.
Measured: 15 minutes
heart rate
The heart rate measurements of the newborns to be included in the study in each group will be performed by the same researcher with the same calibrated device in the infant monitoring unit.
Measured: 15 minutes
Crying Time
During the Hep B vaccination procedure, a stopwatch will be started from the moment the newborn starts crying. "Samsung" brand "Note 10" model phone stopwatch will be used for the stopwatch. During the procedure, the stopwatch will be turned on when the baby cries, and the stopwatch will be stopped when the crying stops.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start24 Apr 2024
- Primary completion29 Aug 2025 (estimated)
- Study completion29 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bartın Unıversity
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Dinç, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06279169
- Sponsor's protocol ID
- 2023-BRT-SBF-113355
- Status last verified
- Apr 2024
- First submitted
- 17 Feb 2024
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Heart Sound and White Noise on Pain and Physiological Parameters During Hepatitis B Vaccine Injection in Newborns: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06279169
- Acronym / sponsor ID
- 2023-BRT-SBF-113355
- Conditions
- Pain, Acute, Newborn; Vitality
- Keywords
- Pain, Acute Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Bartın UnıversityUniversity, hospital or other
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 29 Aug 2025 (estimated)
- Study completion
- 29 Aug 2025 (estimated)
- First posted
- 26 Feb 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.
It can cause physiological and behavioral changes in infants such as pain, tachycardia, hypoxemia, increased blood pressure, grimacing, prolonged crying, and irritability. Vaccination is an important part of neonatal nursing care. Newborns express their pain nonverbally and behaviorally. Therefore, any pain assessment is based on the ability of others to recognize pain symptoms. This randomized controlled trial was planned to evaluate the effect of heart sound and white noise on pain and physiological parameters during intramuscular injection of hepatitis B vaccine in newborns. This randomized controlled study used parallel trial design.
Detailed description
The research hypotheses are H1: Neonates in the heart sound group will have lower procedural pain scores than neonates in the control group. H2: Neonates in the white noise group will have lower procedural pain scores than neonates in the control group. H3: Neonates in the heart sound group have lower procedural heart rate peak values than neonates in the control group. H4: Neonates in the white noise group have lower procedure-related peak heart rates than neonates in the control group. H5: Neonates in the heart sound group have higher procedural oxygen saturation values than neonates in the control group. H6: Neonates in the white noise group have higher procedural oxygen saturation values than neonates in the control group.
Methods The study was designed as a randomized controlled trial. The population of this study will consist of newborns who are followed up at Bartın Maternity and Children's Hospital. Statistical power, type I error, effect size, and study design will be taken into account when calculating the sample size. The study will be designed to have a power of at least 80% and a type I error rate of 5%. As there is no similar study evaluating the effect of heart tones and white noise on pain and physiological parameters during hepatitis B vaccination in children, the effect size of the study will be aimed at medium (0.25) to determine the sample size. Based on a medium effect size (f: 0.25), 80% (1 - β error) power and 95% (α error) confidence level, and taking into account data loss, it was calculated that the sample size should be increased by 10%, and the sample size of 33 newborns in each group should consist of 99 newborns in total G*Power 3.1.9.7.
Before starting the study, mothers will be informed about the purpose of the study and the heart sound and white noise applications to be applied and their written informed consent will be obtained. After written informed consent has been obtained from the mothers, the newborns will be randomised to 3 groups (heart sound, white noise, control group) by a statistician independent of the study (www. randomize.org) using a computer program. All newborns will receive a standardised approach. Standardised approach: All Hep B vaccine administration will be performed by a nurse during the morning shift and administered intramuscularly through the vastus lateralis muscle at a 90-degree angle using a 1-inch 23-gauge needle to infants in all three groups. All conditions such as room temperature (25°C), light, injection procedure will be the same in all three groups. Neonates will be fed at least 30 minutes before the procedure. Care will be taken to avoid non-nutritive sucking, touching or swaddling the baby during the procedure to avoid confusion with other pain relief methods. Aseptic techniques are observed during all procedures.
During the implementation of the measurement tools, the researcher will go to the relevant facility herself and the data collection forms will be applied face to face. The researcher and the nurse will not use any aromatic substances in the baby monitoring room during the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Heart sound group | Experimental | Behavioral: Heart SoundIn the heart sound group, the heart sound with an average heart rate of 70 beats is transmitted to the loudspeaker via an Mp3 player. Two small 200 W loudspeakers (SONY®)/"JBL" brand loudspeakers are used, placed on either side of the newborn's head, 30 cm from the newborn's ears. |
| White noise group | Experimental | Behavioral: White NoiseIn the white noise group, the mother of the baby is told that the white noise to be used in the study will be used for pain relief. For the white noise, the musician Osman Orhan's colic album, which was released by the production and often used in the literature. The song "Bebeğiniz Ağlamasın Pt-3" from the album "Kolik" will be used (permission to use it in this work has been granted by ON Music Production). The volume is set to 45 db. The "JBL" loudspeaker is placed on the newborn's toe 5 minutes before the procedure, about 30 cm from the newborn's ear, and white noise is played 5 minutes before, during (at the 1st minute) and 5 minutes after the administration of the Hep B vaccine. |
| Control | No intervention | –Newborns in the control group will not receive any intervention other than Hepatitis B vaccination. |
Who may qualify
- Ages
- 2 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Gestational age of 38-41 weeks,
- Newborn birth weight >2500 g
- Stable vital signs before the procedure,
- Postanatal age between 2-28 days,
- No contraindications to the administration of hepatitis B vaccine
Key exclusion criteria (11 listed)
- Newborn babies requiring respiratory support,
- Newborns with any neurological disorder (seizures)
- Newborns taking opiates or born to mothers taking opiates
- Newborns receiving muscle relaxants, sedatives, analgesics
- Babies with major congenital anomalies
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 |
|---|---|---|
| Heart SoundIn the Heart sound group, this sound will be played to the newborn 5 minutes before Hep B vaccine administration, during the procedure (at 1 minute) and 5 minutes after Hep B vaccine administration | Behavioural | Heart sound group |
| White NoiseMusician Osman Orhan's song "Bebeğiniz Ağlamasın" from his album Kolik will be used for white noise. The volume will be set to 45 db. | Behavioural | White noise group |
Primary outcome
The Newborn Infant Pain Scale (NIPS)
Time frame: 15 minutes
Used to assess behavioral and physiological pain responses of preterm and term infants. The Neonatal Infant Pain Scale is a Likert-type scale consisting of 6 parameters including facial movements (0; relaxed, 1; restless), crying (0; no crying, 1; moaning, 2; loud crying), breathing (0; relaxed, 1; variable-irregular), arm (0; relaxed-free, 1; flexion-extension), leg (0; relaxed-free, 1; flexion-extension) and sleep-wakefulness (0; sleep-wakefulness peaceful, 1; restless). According to the scale, 7 is interpreted as the highest level of pain and 0 as the lowest level of pain. A high score indicates greater severity of pain.
3 secondary outcomes
oxygen saturation
Time frame: 15 minutes
heart rate
Time frame: 15 minutes
Crying Time
Time frame: 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heart Sound and White Noise in people with Pain, Acute and Newborn; Vitality, run by Bartın Unıversity 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 10 inclusion and 11 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma Dinc, Asst.Prof (+905383555685, fatmadinc@bartin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Newborn Infant Pain Scale (NIPS) (time frame: 15 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 26 Apr 2024.