Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06252155 |
Other study ID # |
2023-03 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 2, 2023 |
Est. completion date |
January 18, 2024 |
Study information
Verified date |
February 2024 |
Source |
Trakya University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
Type of Research This study was conducted in a prospective, two-arm and randomized controlled
manner.
Where the Research Was Conducted The research was conducted on mothers who gave birth at
Trakya University Health Research and Application Center Maternity Service between May and
December 2023.
Population/Sample of the Research The power analysis of the study was performed with the
G*POWER 3.1.9.7 (Power analysis statistical software) program. To determine the sample size
of the study, to measure the effect of music applied to mothers with term babies on
postpartum blues, 41 control groups and 41 control groups were used to test a difference in
the predicted medium effect size (d=.5) based on our clinical observation with a 5% margin of
error and 80% power value. It was calculated that a total of 82 mothers, 41 in the
intervention group, should be included in the study.
Data Collection Tools-Validity and Reliability Information In the study, "Personal
Information Form", "Stein Blues Scale" and "Edinburgh Postpartum Depression Scale", which
were created by the researchers by scanning the literature, were used.
Personal Information Form: Containing the personal characteristics of mothers who have just
given birth (age, mother's education level, mother's employment status, family type, spouse's
age, spouse's education status, spouse's employment status, income status, place of
residence, smoking status, alcohol use status, 12 questions regarding physical exercise
status, 10 questions about obstetric characteristics (number of pregnancies, number of live
births, number of children, number of miscarriages, number of curettages, type of birth,
intentional pregnancy status, planned pregnancy status, gender of the baby, week of birth of
the baby), psycho-social characteristics (the state and frequency of feeling tense in daily
life, the methods used to calm down when tense in daily life, the situation of using
traditional and complementary methods to calm down when tense in daily life, and which method
is used to calm down when tense in daily life, the traditional and complementary methods used
to calm down when tense in daily life). If using complementary methods, sharing with the
source of information and healthcare personnel, current emotional state, emotional state
regarding pregnancy, psychological support from spouse during pregnancy, psychological
support from relatives (such as mother/sibling) during pregnancy, social status during
pregnancy. It consists of a total of 34 questions, 12 of which are evaluating relationships,
spending time with friends during pregnancy.
Stein Blues Scale (SBS): 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. While mild blues
symptoms apply to scores between 3 and 8, scores of 8 and above indicate severe blues
symptoms. Stein tested the validity and reliability of the scale according to the 60-question
self-administered Goldberg Scale (r = .80) and found its reliability to be r = .70. Stein
scale questions screen for symptoms of depression, crying, restlessness, anxiety, fatigue,
tension, irritability, poor concentration, forgetfulness, confusion, anorexia, daydreaming
and headache in women who have just given birth. In this study, the Cronbach's Alpha value of
the scale was determined as .99.
Edinburgh Postpartum Depression Scale (EPDS); to determine the risk of depression in women in
the postpartum period. EPDS is used in our country and the Cronbach Alpha value of the scale
was found to be .87. 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.
Procedure Mothers who met the inclusion criteria of the study were visited in the maternity
ward within the first 12 hours after birth and offered to participate in the study.
Participants were given a consent form containing information stating that previous studies
had shown the positive effects of singing on various aspects of well-being and that the
intervention was therefore designed to investigate the effects of listening to music on
emotional changes in the postnatal context. After obtaining informed written consent, they
were randomized to the control or intervention group and received the baseline questionnaire,
which included the "Personal Information Form", the "Stein Blues Scale" and the "Edinburgh
Postpartum Depression Scale". A member of the study team went to the ward where the study was
conducted for 2 days to collect the completed questionnaire, and when he went to collect the
completed questionnaire for the last time, he gave the mothers a small gift as a thank you
for their participation in the study. After the initial measurement, the mother was asked to
listen to the selected music within 12 hours and repeat the scales after listening to the
music. 24 hours after the first music listening application, the mother was asked to apply
the same scales again, listen to the music, and repeat the scales as the final test. An
overview of the procedure. Information about the flow and which survey was administered when
is given.
Music application: 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 works played . 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. The mother will start
listening to the piece with the help of the researchers' phone and a portable Bluetooth
speaker, wireless sound bomb, or headphones. The volume of the music will be set at 60-66
beats per minute .
Ethical Aspect of Research For the ethical suitability of the research, the Istanbul Kent
University Health Sciences Scientific Research and Publication Ethics Board meeting dated
25.04.2023 and numbered 2023-03 received ethical approval and written permission from the
Chief Physician of Trakya University Health Research and Application Center for the
collection of data and a newborn who agreed to participate in the study. Written informed
consent was obtained from the mothers who participated. The research was carried out in
accordance with the rules of the Declaration of Helsinki.