Breast FeedingNCT06523283
The Effect of Nature Images Accompanied by Music on Breastfeeding, Breastfeeding Satisfaction and Maternal Attachment"
A study testing Natural Landscape Pictures Accompanied by Music in people with Breast Feeding, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).
Trial summary
The study was planned as a randomized controlled study to evaluate the effect of using natural landscape pictures accompanied by music during breastfeeding for lactating mothers on breastfeeding, breastfeeding satisfaction and maternal attachment. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding
- What is being tested?
- Natural Landscape Pictures Accompanied by Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2024to 10 Aug 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntarily agreeing to participate in the research
- Being over 18 years old
- Being at least a primary school graduate
- Not having a diagnosed psychiatric disease
- Without mental disability
- Turkish speakers and those who do not have communication problems
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- Primiparous mothers
- The mother does not have any problems that would prevent her from breastfeeding (e.g., nipple cracks)
- The child is not premature
- Mothers who gave birth at term
- The baby is not low birth weight
- Mothers who do not have any problems that would prevent the baby from breastfeeding
Who cannot join
- Being illiterate
- Being under 18 years old
- Having a diagnosed psychiatric illness
- Having mental disability and communication problems
- Those who do not speak Turkish and have communication problems
- Non-primiparous mothers
Show all 11Show fewer
- The mother has any problems that may prevent her from breastfeeding (e.g., nipple cracks)
- Having a premature baby
- Mothers who did not give birth at term
- Low birth weight of the baby
- Mothers who have any problems that may prevent the baby from breastfeeding
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Adiyaman University Education and Research Hospital
Adıyaman, 02100
Kasım TURGUT, PhD, +90 416 216 10 15, kturgut@adiyaman.edu.tr
Nuray AYDIN, MASTER
About this study
Official title: The Effect of the Use of Natural Landscape Pictures Accompanied by Music on Breastfeeding, Breastfeeding Satisfaction and Maternal Attachment to Lactation-Period Mothers During Breastfeeding
The study was planned as a randomized controlled study to evaluate the effect of using natural landscape pictures accompanied by music during breastfeeding for lactating mothers on breastfeeding, breastfeeding satisfaction and maternal attachment.
Read the detailed description
This research is planned as a randomized controlled study to evaluate the effect of using natural landscape pictures accompanied by music during breastfeeding on breastfeeding, breastfeeding satisfaction, and maternal attachment in lactating mothers.
The research will be conducted with primiparous mothers who apply to Adıyaman University Training and Research Hospital Gynecology clinics between January 2024 and August 2024 and meet the inclusion criteria. The study will include a total of 90 participants, divided into one intervention group and one control group.
As a pre-test, the Socio-Demographic Data Survey, LATCH Breastfeeding Diagnosis and Evaluation Scale, Visual Analogue Scale for Satisfaction Evaluation, and Maternal Attachment Scale will be administered to mothers who have just given birth at the clinic. Both groups will receive breastfeeding education.
For the intervention group, mothers will watch nature scene pictures accompanied by music prepared by the researcher. This will be done once in the hospital, once during a home visit after discharge, and then daily at home, with the researcher checking in by phone to ensure the mothers watch the scenes eight more times. The intervention will be conducted a total of 10 times.
Finally, the data collection phase will be completed by administering the post-test surveys to both groups.
- Conditions
- Breast Feeding
- Being tested
- Natural Landscape Pictures Accompanied by Music
- Keywords
- Breast Feeding, Maternal attachment, Music therapy, Maternal Satisfaction
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural Landscape Pictures Accompanied by MusicOther
after data collection tools filled by participants , they will watch the video one time in hospital bed while breastfeeding , second time in their home while researchers is there and they will also receive the video link so they will contunie to watch video 8 more time. in total 10 sessions will be completed.
| Study group | Role | What they receive |
|---|---|---|
| Natural Landscape Pictures Accompanied by Music İntervention Group | Experimental | Natural Landscape Pictures Accompanied by Music video will be applied to interevention group. They will watch the video for 10 sessions. Receives: Other: Natural Landscape Pictures Accompanied by Music |
| Control group with no intervention | No intervention | Control group will not receive any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Socio-Demographic Data Survey
It consists of 14 questions about the sociodemographic characteristics of mothers, prepared by the researcher through a literature review on the subject and in line with the suggestions of the thesis monitoring committee members."
Measured: Ten days
LATCH Breastfeeding Diagnostic and Evaluation Scale
It is a diagnostic method used to evaluate breastfeeding success, first created in 1986 by likening it to the APGAR score system in terms of scoring method. The average application time varies between 7-10 minutes. It consists of five evaluation criteria, and the abbreviation of the first letters of the English equivalents of these criteria forms the name of the scale. L; latch on the breast, A; audible swallowing, T; type of the nipple, C; comfort breast/nipple, and H; hold/help. Each item is evaluated between 0-2 points. The highest total score that can be obtained is 10, and a high score indicates high breastfeeding success. The Turkish reliability study of the tool was conducted by Yenal and Okumuş, and it was found to be a suitable and reliable diagnostic tool for use. While the Cronbach's alpha value of the original form of the scale was found to be 0.93, it was found to be 0.95 in the Turkish adaptation study.
Measured: Ten days
The Visual Analog Scale (VAS)
It is an extremely simple, effective, and repeatable measurement tool that requires minimal equipment and can be used to measure pain, nausea, vomiting, and satisfaction. The VAS is a 10 cm long scale drawn horizontally or vertically. The easiest way to assess satisfaction is to ask the individual if they are satisfied. However, a yes or no answer is not sufficient to evaluate satisfaction. Therefore, the use of a scale in assessing satisfaction transforms the quality of satisfaction described by individuals/patients with numbers or words into an objective measure, eliminating different interpretations among the healthcare team providing patient care. The visual analog scale consists of numbers ranging from 0 to 10. In evaluating patient satisfaction, 0 is considered not at all satisfied and 10 is considered very satisfied.
Measured: Ten days
Maternal Attachment Scale
Each item is a 26-item, four-point Likert scale ranging from "always" to "never." Each item contains direct statements and is scored as follows: Always (a) = 4 points, Often (b) = 3 points, Sometimes © = 2 points, and Never (d) = 1 point. A high score indicates a high level of maternal attachment. The lowest score obtainable from the scale is 26, and the highest score is 104.
Measured: Ten days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start18 Jan 2024
- Primary completion2 Aug 2024 (estimated)
- Study completion10 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies 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
- One intervention group and one control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasan Kalyoncu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NURAY AYDIN, Hasan Kalyoncu University
- Investigators
- Nuray Aydın, Master, Principal investigator, Hasan Kalyoncu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523283
- Sponsor's protocol ID
- HasanKU-SBF-RK-01
- Status last verified
- Jul 2024
- First submitted
- 22 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- 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 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Use of Natural Landscape Pictures Accompanied by Music on Breastfeeding, Breastfeeding Satisfaction and Maternal Attachment to Lactation-Period Mothers During Breastfeeding
- ClinicalTrials.gov ID
- NCT06523283
- Acronym / sponsor ID
- HasanKU-SBF-RK-01
- Conditions
- Breast Feeding
- Keywords
- Breast Feeding, Maternal attachment, Music therapy, Maternal Satisfaction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hasan Kalyoncu UniversityUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 2 Aug 2024 (estimated)
- Study completion
- 10 Aug 2024 (estimated)
- First posted
- 26 Jul 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.
The study was planned as a randomized controlled study to evaluate the effect of using natural landscape pictures accompanied by music during breastfeeding for lactating mothers on breastfeeding, breastfeeding satisfaction and maternal attachment.
Detailed description
This research is planned as a randomized controlled study to evaluate the effect of using natural landscape pictures accompanied by music during breastfeeding on breastfeeding, breastfeeding satisfaction, and maternal attachment in lactating mothers.
The research will be conducted with primiparous mothers who apply to Adıyaman University Training and Research Hospital Gynecology clinics between January 2024 and August 2024 and meet the inclusion criteria. The study will include a total of 90 participants, divided into one intervention group and one control group.
As a pre-test, the Socio-Demographic Data Survey, LATCH Breastfeeding Diagnosis and Evaluation Scale, Visual Analogue Scale for Satisfaction Evaluation, and Maternal Attachment Scale will be administered to mothers who have just given birth at the clinic. Both groups will receive breastfeeding education.
For the intervention group, mothers will watch nature scene pictures accompanied by music prepared by the researcher. This will be done once in the hospital, once during a home visit after discharge, and then daily at home, with the researcher checking in by phone to ensure the mothers watch the scenes eight more times. The intervention will be conducted a total of 10 times.
Finally, the data collection phase will be completed by administering the post-test surveys to both groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- One intervention group and one control group
| Arm | Type | Receives |
|---|---|---|
| Natural Landscape Pictures Accompanied by Music İntervention Group | Experimental | Other: Natural Landscape Pictures Accompanied by MusicNatural Landscape Pictures Accompanied by Music video will be applied to interevention group. They will watch the video for 10 sessions. |
| Control group with no intervention | No intervention | –Control group will not receive any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntarily agreeing to participate in the research
- Being over 18 years old
- Being at least a primary school graduate
- Not having a diagnosed psychiatric disease
- Without mental disability
Key exclusion criteria (11 listed)
- Being illiterate
- Being under 18 years old
- Having a diagnosed psychiatric illness
- Having mental disability and communication problems
- Those who do not speak Turkish and have communication 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 |
|---|---|---|
| Natural Landscape Pictures Accompanied by Musicafter data collection tools filled by participants , they will watch the video one time in hospital bed while breastfeeding , second time in their home while researchers is there and they will also receive the video link so they will contunie to watch video 8 more time. in total 10 sessions will be completed. | Other | Natural Landscape Pictures Accompanied by Music İntervention Group |
Primary outcome
Socio-Demographic Data Survey
Time frame: Ten days
It consists of 14 questions about the sociodemographic characteristics of mothers, prepared by the researcher through a literature review on the subject and in line with the suggestions of the thesis monitoring committee members."
LATCH Breastfeeding Diagnostic and Evaluation Scale
Time frame: Ten days
It is a diagnostic method used to evaluate breastfeeding success, first created in 1986 by likening it to the APGAR score system in terms of scoring method. The average application time varies between 7-10 minutes. It consists of five evaluation criteria, and the abbreviation of the first letters of the English equivalents of these criteria forms the name of the scale. L; latch on the breast, A; audible swallowing, T; type of the nipple, C; comfort breast/nipple, and H; hold/help. Each item is evaluated between 0-2 points. The highest total score that can be obtained is 10, and a high score indicates high breastfeeding success. The Turkish reliability study of the tool was conducted by Yenal and Okumuş, and it was found to be a suitable and reliable diagnostic tool for use. While the Cronbach's alpha value of the original form of the scale was found to be 0.93, it was found to be 0.95 in the Turkish adaptation study.
The Visual Analog Scale (VAS)
Time frame: Ten days
It is an extremely simple, effective, and repeatable measurement tool that requires minimal equipment and can be used to measure pain, nausea, vomiting, and satisfaction. The VAS is a 10 cm long scale drawn horizontally or vertically. The easiest way to assess satisfaction is to ask the individual if they are satisfied. However, a yes or no answer is not sufficient to evaluate satisfaction. Therefore, the use of a scale in assessing satisfaction transforms the quality of satisfaction described by individuals/patients with numbers or words into an objective measure, eliminating different interpretations among the healthcare team providing patient care. The visual analog scale consists of numbers ranging from 0 to 10. In evaluating patient satisfaction, 0 is considered not at all satisfied and 10 is considered very satisfied.
Maternal Attachment Scale
Time frame: Ten days
Each item is a 26-item, four-point Likert scale ranging from "always" to "never." Each item contains direct statements and is scored as follows: Always (a) = 4 points, Often (b) = 3 points, Sometimes © = 2 points, and Never (d) = 1 point. A high score indicates a high level of maternal attachment. The lowest score obtainable from the scale is 26, and the highest score is 104.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 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.
Nuray Aydın, Master principal investigator
Hasan Kalyoncu 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 Natural Landscape Pictures Accompanied by Music in people with Breast Feeding, run by Hasan Kalyoncu 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 12 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 Jul 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 Nuray Aydın, Master (+90 537 291 51 61, aydin_nuray@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Socio-Demographic Data Survey (time frame: Ten days). The study lists 4 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 26 Jul 2024.