NCT06523283

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 26, 2024

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2024

Completed
Last Updated

July 26, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

July 22, 2024

Last Update Submit

July 25, 2024

Conditions

Keywords

Breast FeedingMaternal attachmentMusic therapyMaternal Satisfaction

Outcome Measures

Primary Outcomes (4)

  • 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."

    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.

    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.

    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.

    Ten days

Study Arms (2)

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.

Other: Natural Landscape Pictures Accompanied by Music

Control group with no intervention

NO INTERVENTION

Control group will not receive any intervention.

Interventions

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.

Natural Landscape Pictures Accompanied by Music İntervention Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adiyaman University Education and Research Hospital

Adıyaman, 02100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Nuray Aydın, Master

    Hasan Kalyoncu University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nuray Aydın, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
outcome assesments will be performed by statistician who has blinded to group allocation.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: One intervention group and one control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 22, 2024

First Posted

July 26, 2024

Study Start

January 18, 2024

Primary Completion

August 2, 2024

Study Completion

August 10, 2024

Last Updated

July 26, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations