Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05228392 |
| Other study ID # |
365 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 16, 2021 |
| Est. completion date |
October 15, 2021 |
Study information
| Verified date |
January 2022 |
| Source |
Ondokuz Mayis University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to compare the effects of listening to lullabies and
self-selected music at home in reducing the distress experienced in the prenatal period and
increasing maternal attachment in pregnant women. This parallel randomized-controlled study
was carried out at obstetrics outpatient clinics in Turkey. For two weeks and 30 minutes
every day at home, the lullaby group (LG) only listened to the lullaby record selected by the
researcher, while the multi-music group (MG) listened to self-selected music from different
records presented to them by the researcher. The control group (CG) only received routine
care. Prenatal distress and maternal attachment levels were assessed at the beginning and end
of the intervention.
Description:
Pregnant women may experience distress due to physical and psychosocial changes, and this
distress affects the development of maternal attachment negatively. Healthcare professionals
are supposed to assess the distress and maternal attachment levels of pregnant women,
facilitate their development of positive coping mechanisms, reduce their distress and
increase their attachment. In this sense, music interventions may be utilized to improve the
physical, emotional and mental health of pregnant women. Based on the information in the
literature, it is known that music therapy can be implemented at home, too. In some studies
that included music interventions carried out at home, anxiety and stress were reduced, and
thus, psychological benefits were facilitated for the pregnancy, labor and postpartum
periods. The purpose of this study is to compare the effects of listening to lullabies and
self-selected music at home in reducing the distress experienced in the prenatal period and
increasing maternal attachment in pregnant women.
This study is an experimental, parallel-group, pretest-posttest randomized-controlled study
that was carried out in compliance with the instructions of CONSORT (as given in the CONSORT
Checklist 2010). The study was conducted at the obstetrics outpatient clinics of a state
hospital located in northern Turkey. The population of the study consisted of healthy
pregnant women presenting to the obstetrics outpatient clinics of the hospital where the
study was conducted for their pregnancy follow-ups. The sample size was calculated using the
G*Power 3.1.9 software. It was determined that each group should include at least 36 pregnant
women according to a 95% confidence interval (1-α), an error margin of 0.05, a power rate of
0.95 and an effect size of d=0.87. The pregnant women who were included in the study (n=120)
were allocated to the lullaby group (LG) (n=40), the multi-music group (MG) (n=40) or the
control group (CG) (n=40) using the simple randomization method. The specialist randomly
allocated each participant to one of the intervention groups (LG and MG) or CG using the
"QuickCalcs - Graph Pad" computer program.Participants who met the inclusion criteria were
included in the groups based on their orders of presenting to the obstetrics outpatient
clinics which were randomly distributed.
The data of the study were collected using a Personal Information Form, the Prenatal Distress
Questionnaire, and the Maternal Antenatal Attachment Scale. Prenatal distress and attachment
levels were assessed at the beginning of the study (pretest) and at the end of the 2-week
music intervention/two weeks of routine care (posttest). All data were collected at the
hospital when the pregnant women arrived there for their pregnancy follow-ups.
The study included two intervention groups and a control group (CG). The interventions groups
were the lullaby group (LG) and the multi-music group (MG). The participants in the control
group did not listen to music. They only received the routine care offered to them in their
hospital visits.
Music interventions (LG and MG) The participants in LG were instructed to only listen to the
recording of lullabies selected by the researcher for two weeks and 30 minutes every day at
home. The participants in MG were given records of music consisting of "nature sounds,
Western classical music, Turkish classical music (in the acemaşiran mode) and lullabies" that
were arranged by the researcher and instructed to listen to select and listen to any of these
at home for two weeks and 30 minutes every day.The participants in the music intervention
groups were informed about the form and conditions of listening to the given music records at
their homes. The music files were sent to the participants via mobile communication
applications (e.g., Telegram, WhatsApp) so that they could listen to them on their own
phones, and the participants were asked to download/save these files. An instructor at the
Musicology department of the university where this study was implemented was consulted
regarding these music records. Based on information published in previous studies, a guide
for listening to music at home in pregnancy was developed [12,16]. Accordingly, lullabies
compatible with a normal heart rate (varying in the range of 60-70 bpm as measured with a
metronome) and with a soft melody and other music pieces mentioned above were used. The
participants were instructed to use their personal headphones in a quiet and dimly lit room
to prevent the effects of ambient sounds while listening to music, adjust the volume of the
music to a level that they preferred and was appropriate, empty their bladder and not be
hungry. The appropriate implementation of these music interventions at home was checked by
the researcher by having phone calls with the participants every day.
Due to the nature of music interventions, the researchers and the participants were not blind
to the study protocol. No intervention was made in the routine care and follow-up processes
of the participants throughout the study.
Data analysis:
All data were analyzed using the IBM SPSS v.23 (IBM Corp. Armonk, NY, USA) program. The
results are presented with descriptive statistics including frequency, percentage, arithmetic
mean, standard deviation, median, minimum and maximum values. Chi-squared test was used for
the categorical variables, and one-way analysis of variance (ANOVA) or Kruskal Wallis-H test
was used for the continuous variables to confirm differences in sociodemographic and
obstetrics characteristics between the groups. The mean NuPDQ and MAAS scores of the groups
were compared using one-way analysis of variance (ANOVA) and Tukey's test, while intragroup
comparisons were made using paired-samples t-test. The level of statistical significance was
accepted as p<0.05.
Ethical considerations:
Before starting the study, ethical approval was obtained from the Clinical Research Ethics
Committee of the university where the study would be conducted (decision data: 10.06.2021,
decision number: 2021/288), and written permission was received from the institution.
Additionally, before implementing the data collection instruments, the aim of the study was
explained to all participants, and written informed consent was obtained from those who
voluntarily agreed to participate.
Limitations There were some limitations in this study. First, as this study was a
single-center study, its results cannot be generalized to all healthy pregnant women. Second,
as no follow-up was made after the two-week music intervention in the study or in the
postpartum period, the long-term effectiveness of having pregnant women listen to lullabies
or other music genres could not be analyzed. Third, asking the participants to listen to
music at home and checking their compliance over the phone created difficulties in terms of
comprehensive implementation in terms of issues such as the duration of the intervention and
its implementation conditions.
