- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06523283
The Effect of Nature Images Accompanied by Music on Breastfeeding, Breastfeeding Satisfaction and Maternal Attachment"
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nuray Aydın, Master
- Phone Number: +90 537 291 51 61
- Email: aydin_nuray@yahoo.com
Study Locations
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Adiyaman, Turkey, 02100
- Recruiting
- Adiyaman University Education and Research Hospital
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Contact:
- Kasım TURGUT, PhD
- Phone Number: +90 416 216 10 15
- Email: kturgut@adiyaman.edu.tr
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Principal Investigator:
- Nuray AYDIN, MASTER
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Natural Landscape Pictures Accompanied by Music İntervention Group
Natural Landscape Pictures Accompanied by Music video will be applied to interevention group.
They will watch the video for 10 sessions.
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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.
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No Intervention: Control group with no intervention
Control group will not receive any intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Socio-Demographic Data Survey
Time Frame: Ten days
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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."
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Ten days
|
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LATCH Breastfeeding Diagnostic and Evaluation Scale
Time Frame: Ten days
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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.
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Ten days
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The Visual Analog Scale (VAS)
Time Frame: Ten days
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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.
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Ten days
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Maternal Attachment Scale
Time Frame: Ten days
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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.
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Ten days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nuray Aydın, Master, Hasan Kalyoncu University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HasanKU-SBF-RK-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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