NCT06252155

Brief Summary

The prospective and two-arm randomized controlled study was conducted on n = 82 (41 = control, 41 = music group) mothers who gave birth at term at Trakya University Health Research and Application Center Maternity Service between May and December 2023. The music group was listened to Turkish music played for 30 minutes every day for 2 postpartum days. Research data were collected through the "Personal Information Form", "Stein Blues Scale (SDS)" and Edinburgh Postpartum Depression Scale (EPDS). The scales used in the research were evaluated four times: pre-, intermediate, follow-up and post-test. Descriptive statistics, Pearson and Spearman's correlation analyzes will be used in the analysis of research data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2023

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

2 days

First QC Date

February 1, 2024

Last Update Submit

February 9, 2024

Conditions

Keywords

Music

Outcome Measures

Primary Outcomes (2)

  • Postpartum blues evaluated using the Edinburgh Postpartum Depression Scale

    It was created by George S. Stein in 1980. Stein used this scale for the first time in a study in which 37 women were included in the first postpartum week and then followed for 3 months. The scale consists of two parts with a total of 13 questions. The first 8 questions are likert-type questions that examine mood symptoms. In the second part, the answers are yes/no; There are 5 questions investigating the presence of symptoms such as headache, restlessness, difficulty concentrating, forgetfulness and confusion. While the scoring of the section containing Likert-type questions varies between 0-4, if there is a symptom in the last 5 questions, 1 point for each is added to the total score. The minimum score is 0 while the maximum score is 26. Patients are asked to answer the scale thinking only of that day (23). While mild blues symptoms apply to scores between 3 and 8, scores of 8 and above indicate severe blues symptoms.

    change from baseline and 1 and 2 day of practice.

  • Depression evaluated using the Stein Blues Scale

    Cox et al. (1987) to determine the risk of depression in women in the postpartum period. EPDS is used . The answers to the 4-point Likert type scale consisting of 10 questions are scored between 0-3. The cut-off score for the scale was taken as 12/13. If the score obtained is 12 and below, the patient is considered not at risk for postpartum depression, and if it is 13 and above, the patient is considered at risk for postpartum depression. Scores from the scale range from 0 to 30.

    change from baseline and 1 and 2 day of practice.

Study Arms (2)

Control

NO INTERVENTION

No intervention will be made to the control group.

Music Group

EXPERIMENTAL

Mothers will listen to music for 30 minutes every day for 2 postpartum days. The type of music to be used in this study will be Turkish music . Turkish music will be preferred in the study because it is a part of the culture in which the study will be conducted. This type of music was preferred because it evokes feelings of happiness, laughter, joy, power, courage and heroism in the human soul. In deciding the type of music listened to in the study, expert opinion was taken from a faculty member teaching music therapy at a state university. During the music session, the mother will take a comfortable position on the sofa or bed. She will also be asked to close her eyes and imagine where she wants to be. She will also be asked to breathe slowly and deeply to regulate her breathing.

Other: Music

Interventions

MusicOTHER

Mothers will listen to music for 30 minutes every day for 2 postpartum days. The type of music to be used in this study will be Turkish music . Turkish music will be preferred in the study because it is a part of the culture in which the study will be conducted. This type of music was preferred because it evokes feelings of happiness, laughter, joy, power, courage and heroism in the human soul. In deciding the type of music listened to in the study, expert opinion was taken from a faculty member teaching music therapy at a state university. During the music session, the mother will take a comfortable position on the sofa or bed. She will also be asked to close her eyes and imagine where she wants to be. She will also be asked to breathe slowly and deeply to regulate her breathing. The mother will be told to feel comfortable, to feel her body relax from head to toe while listening to music, to focus on the music and to free her thoughts.

Music Group

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18-49,
  • To can read, understand and write Turkish,
  • Had a term birth (single birth at 38 weeks and above),
  • Had a normal vaginal delivery or cesarean delivery after an uncomplicated pregnancy,
  • Has stable vital signs, who is undergoing infertility treatment not having any chronic disease (such as hypertension, diabetes mellitus),
  • Do not experiencing serious depression, anxiety and stress, not having any organic or non-organic disease that may cause cognitive impairment (such as delirium, dementia, mental retardation, etc.),
  • Not having serious maternal complications,
  • Mothers who volunteered to participate in the study

You may not qualify if:

  • Under 18 and over 49 years of age,
  • Preterm birth (under 37 weeks and/or multiple birth),
  • After a complicated pregnancy, birth has not been completed by normal vaginal delivery or cesarean delivery method,
  • Without stable vital signs,
  • Those who have received infertility treatment,
  • Having a chronic disease (such as hypertension, diabetes mellitus),
  • Experiencing serious depression, anxiety and stress,
  • Having any organic or non-organic disease that may cause cognitive impairment (such as Delirium, Dementia, Mental Retardation, etc.),
  • Serious maternal complications,
  • Mothers who did not volunteer to participate in the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bartın University

Bartın, 74010, Turkey (Türkiye)

Location

Related Publications (1)

  • Kucukkaya B, Can I, Guler G. The effect of music played to new birth mothers on postpartum blues: A randomized controlled trial. Early Hum Dev. 2024 May;192:106013. doi: 10.1016/j.earlhumdev.2024.106013. Epub 2024 Apr 17.

MeSH Terms

Interventions

Music Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Before starting the research, two groups of mothers will be randomly formed. As a randomization method, mothers who meet the sampling inclusion criteria determined in the research will be identified and listed. Individuals to be taken into two groups will be determined by randomization method from the random numbers table. (http://www.stattrek.com/statistics/randomnumber-generator.aspx).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof

Study Record Dates

First Submitted

February 1, 2024

First Posted

February 9, 2024

Study Start

May 2, 2023

Primary Completion

May 4, 2023

Study Completion

January 18, 2024

Last Updated

February 12, 2024

Record last verified: 2024-02

Locations