Amount of Breast MilkNCT06307756
The Effect of Music on Maternal Stress and Milk Amount
A study testing Music group in people with Amount of Breast Milk and Maternal Anxiety Level, run by Adiyaman University at 1 site in Turkey (Türkiye).
Trial summary
Premature babies who have to deal with life-threatening situations have to spend the first days of their lives in intensive care units. Mothers who plan to return home with their babies during the postpartum period may experience stress due to their children being monitored in intensive care. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Amount of Breast Milk, Maternal Anxiety Level
- What is being tested?
- Music group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2023to 22 Apr 2024
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mothers whose babies are born prematurely (gestational age between 32-37 weeks), -whose babies do not have any congenital anomalies,
- whose babies are not connected to mechanical ventilation,
- who are over 18 years of age, who are not diagnosed with any psychological disease and
- who agree to participate in the study will be included in the study.
Who cannot join
- Greater than 32-37 weeks of gestation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sağlık Bilimleri Üniversitesi Gazi Yaşargil Eğitim ve Araştırma Hastanesi
Diyarbakır
About this study
Official title: The Effect of Music Played to Mothers of Premature Babies Inpatient Neonatal Intensive Care Unit on Their Stress Levels and Milk Amount
Premature babies who have to deal with life-threatening situations have to spend the first days of their lives in intensive care units. Mothers who plan to return home with their babies during the postpartum period may experience stress due to their children being monitored in intensive care. It is stated that mothers of babies in the neonatal intensive care unit experience stress and anxiety due to reasons such as being separated from their babies, the baby's illness, the baby's sensitive body structure, the baby's appearance and behavior, and the baby's dependence on devices. This stress experienced by mothers of premature babies can prevent mothers from providing enough milk to feed their babies. Mothers whose babies are in the neonatal intensive care unit cannot have adequate contact with their babies and cannot breastfeed; It causes insomnia, stress and anxiety, and the hormonal axis is disrupted, negatively affecting the amount of breast milk. In order to support the healing process of preterm babies, it is important to increase the amount of milk produced by mothers and increase the rate at which babies can receive breast milk. Music improves endothelial function by dilating the vessels; It has been reported that it reduces mental stress by increasing the release of nitrite oxide and endorphins and causes many physiological reactions such as a decrease in blood pressure and pulse. This study will examine the effect of music played to mothers with premature babies on maternal anxiety and the amount of breast milk.
- Conditions
- Amount of Breast Milk, Maternal Anxiety Level
- Being tested
- Music group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music groupOther
Mothers will be informed about the application before the procedure. Mothers who agree to participate in the study will be asked to listen to music that relaxes them for 20 minutes a day for 4 days. The mothers' state anxiety levels and milk quantities will be evaluated before starting the application and every day during the application. Mothers' anxiety levels will be evaluated with the "State Anxiety Inventory". Mothers' anxiety levels and milk quantities will be evaluated every day at 11.45 when they come to the NICU to express milk.
| Study group | Role | What they receive |
|---|---|---|
| Music group | Experimental | Mothers will be informed about the application before the procedure. Mothers who agree to participate in the study will be asked to listen to music that relaxes them for 20 minutes a day for 4 days. The mothers' state anxiety levels and milk quantities will be evaluated before starting the application and every day during the application. Mothers' anxiety levels will be evaluated with the "State Anxiety Inventory". Mothers' anxiety levels and milk quantities will be evaluated every day at 11.45 when they come to the NICU to express milk. Receives: Other: Music group |
| Control group | No intervention | After mothers are informed about the study, mothers who agree to participate in the study will be included in the control group by randomization method. No intervention will be made to mothers in the control group. The mothers' state anxiety levels and milk quantities will be evaluated at the first meeting with the mothers and every day for four days. Mothers' anxiety levels will be evaluated with the "State Anxiety Inventory". Mothers' anxiety levels and milk quantities will be evaluated every day at 11.45 when they come to the NICU to express milk. |
What is being measured
The primary outcome is the main question the study is designed to answer.
amount of breast milk measured at the same time every day
Measured: 4 months
Secondary outcomes (1)
State Anxiety Inventory
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start15 Nov 2023
- Primary completion15 Apr 2024
- Study completion22 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amount of Breast MilkStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maksude YILDIRIM, Adiyaman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06307756
- Sponsor's protocol ID
- SayıNo:521
- Status last verified
- Jun 2024
- First submitted
- 13 Feb 2024
- Last updated
- 11 Jun 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 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Played to Mothers of Premature Babies Inpatient Neonatal Intensive Care Unit on Their Stress Levels and Milk Amount
- ClinicalTrials.gov ID
- NCT06307756
- Acronym / sponsor ID
- SayıNo:521
- Conditions
- Amount of Breast Milk, Maternal Anxiety Level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Adiyaman UniversityUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 13 Mar 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.
Premature babies who have to deal with life-threatening situations have to spend the first days of their lives in intensive care units. Mothers who plan to return home with their babies during the postpartum period may experience stress due to their children being monitored in intensive care. It is stated that mothers of babies in the neonatal intensive care unit experience stress and anxiety due to reasons such as being separated from their babies, the baby's illness, the baby's sensitive body structure, the baby's appearance and behavior, and the baby's dependence on devices. This stress experienced by mothers of premature babies can prevent mothers from providing enough milk to feed their babies. Mothers whose babies are in the neonatal intensive care unit cannot have adequate contact with their babies and cannot breastfeed; It causes insomnia, stress and anxiety, and the hormonal axis is disrupted, negatively affecting the amount of breast milk. In order to support the healing process of preterm babies, it is important to increase the amount of milk produced by mothers and increase the rate at which babies can receive breast milk. Music improves endothelial function by dilating the vessels; It has been reported that it reduces mental stress by increasing the release of nitrite oxide and endorphins and causes many physiological reactions such as a decrease in blood pressure and pulse. This study will examine the effect of music played to mothers with premature babies on maternal anxiety and the amount of breast milk.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music group | Experimental | Other: Music groupMothers will be informed about the application before the procedure. Mothers who agree to participate in the study will be asked to listen to music that relaxes them for 20 minutes a day for 4 days. The mothers' state anxiety levels and milk quantities will be evaluated before starting the application and every day during the application. Mothers' anxiety levels will be evaluated with the "State Anxiety Inventory". Mothers' anxiety levels and milk quantities will be evaluated every day at 11.45 when they come to the NICU to express milk. |
| Control group | No intervention | –After mothers are informed about the study, mothers who agree to participate in the study will be included in the control group by randomization method. No intervention will be made to mothers in the control group. The mothers' state anxiety levels and milk quantities will be evaluated at the first meeting with the mothers and every day for four days. Mothers' anxiety levels will be evaluated with the "State Anxiety Inventory". Mothers' anxiety levels and milk quantities will be evaluated every day at 11.45 when they come to the NICU to express milk. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Mothers whose babies are born prematurely (gestational age between 32-37 weeks), -whose babies do not have any congenital anomalies,
- whose babies are not connected to mechanical ventilation,
- who are over 18 years of age, who are not diagnosed with any psychological disease and
- who agree to participate in the study will be included in the study.
Key exclusion criteria (1 listed)
- Greater than 32-37 weeks of gestation
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 |
|---|---|---|
| Music groupMothers will be informed about the application before the procedure. Mothers who agree to participate in the study will be asked to listen to music that relaxes them for 20 minutes a day for 4 days. The mothers' state anxiety levels and milk quantities will be evaluated before starting the application and every day during the application. Mothers' anxiety levels will be evaluated with the "State Anxiety Inventory". Mothers' anxiety levels and milk quantities will be evaluated every day at 11.45 when they come to the NICU to express milk. | Other | Music group |
Primary outcome
amount of breast milk measured at the same time every day
Time frame: 4 months
1 secondary outcome
State Anxiety Inventory
Time frame: 4 months
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 11 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Amount of Breast Milk
Recruiting
Maximising Maternal Milk for Preterm Infant
Breastfeeding, Prematurity
RecruitingObservational study
A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH® (Palopegteriparatide)
Hypoparathyroidism
RecruitingObservational study
Single-center Evaluation of Human Milk Quantity and Quality Over Five Years
Lactating Women - Human Milk Donors
Recruiting
Marmet and Oxytocin Massage for Breast Milk Increase
Healhty
Not yet recruiting
the Effect of Virtual Reality Glasses on Women Who Milk Their Babies by Milking
Human Milk, Breast Milk
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.
The record lists no contact. Use the official record to reach the sponsor.
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 group in people with Amount of Breast Milk and Maternal Anxiety Level, run by Adiyaman 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 4 inclusion and 1 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 11 Jun 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?
amount of breast milk measured at the same time every day (time frame: 4 months). 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 11 Jun 2024.