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Anxiety, Stress-Related, in PregnancyNCT05221489

The Effects of Listening to Lullabies and Self-selected Music on Prenatal Stress and Anxiety in Pregnant Women

A study testing listening to lullabies or self-selected music in people with Anxiety, Stress-Related, in Pregnancy, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Nulliparous women experience more anxiety and stress during their first transition to motherhood during pregnancy due to inexperience. The aim of this study is to compare the effects of listening to lullabies and the music of their choice at home on reducing the anxiety and stress experienced by nulliparous pregnant… Read more about this study

Who is it for?
Ages 19 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Anxiety, Stress-Related, in Pregnancy
What is being tested?
listening to lullabies or self-selected music
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Aug 2021to 15 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Willing to participate
  • Healthy
  • 19 years and older
  • 36th and above gestational week
  • Nulliparous
  • No fetal anomaly
Show all 10Show fewer
  • Literate
  • Pregnant women who have a WhatsApp application on their phone and can use this application
  • Do not have a psychiatric problem
  • Speaking Turkish

Who cannot join

  • Unwilling to participate
  • Having a risky pregnancy
  • Below the 36th gestational week
  • Multiparous
  • Fetal anomaly
  • Mental, cognitive, psychiatric, hearing and vision problems
Show all 9Show fewer
  • Illiterate
  • Do not have WhatsApp application on their phone and cannot use this application
  • Do not speak Turkish

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Fırat University, Gynecology and Obstetrics Polyclinics

    Elâzığ

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of Listening to Lullabies and Self-selected Music at Home on Prenatal Stress and Anxiety in Nulliparous Pregnant Women: A Randomized-controlled Study

Nulliparous women experience more anxiety and stress during their first transition to motherhood during pregnancy due to inexperience. The aim of this study is to compare the effects of listening to lullabies and the music of their choice at home on reducing the anxiety and stress experienced by nulliparous pregnant women.

This parallel randomized controlled trial was conducted in the obstetrics and gynecology outpatient clinics of a university hospital in eastern Turkey. Lullaby group (LG) recorded only the lullaby chosen by the researcher at home for 30 minutes a day for 2 weeks; mix music group (MG) listened to any of the music recordings presented to them by the researcher. The control group (CG) received general care only. Antenatal stress and anxiety levels were evaluated at the beginning and end of the study.

Read the detailed description

Especially, nulliparous women who have experienced their first pregnancy may lose their control while making the first transition to motherhood and incorporating motherhood roles into other areas of their lives due to inexperience, and may be more vulnerable to stress and anxiety. It has been reported that these pregnant women have higher anxiety than those who have given birth. Antenatal anxiety and stress negatively affect maternal and fetal health. Health care professionals can benefit from music interventions to evaluate the anxiety and stress levels of pregnant women, especially in the last trimester, and to improve their physical, emotional and mental health. In some studies, music interventions made at home for pregnant women reduced anxiety and stress, thus providing psychological benefits during pregnancy, childbirth and postpartum period. The aim of this study is to compare the effects of listening to lullabies and the music of their choice at home on reducing the anxiety and stress experienced by nulliparous pregnant women.

This research is a randomized controlled experimental study in parallel group pretest-posttest design. The research was carried out in the obstetrics and gynecology outpatient clinics of a university hospital in eastern Turkey.

The population of the study consisted of healthy pregnant women who applied to the obstetrics clinic of the hospital where the study was conducted for pregnancy follow-up. G ∗ Power 3.1.9 software was used to calculate the sample size of the study. In the power analysis based on state and trait anxiety inventory scores, at least 35 pregnant women were included in each group with 95% confidence interval (1-α), 95.5% test power (1-β), 0.05 error and d=0.887 effect size. needed was determined. The pregnant women (n=16) included in the study were randomly assigned to the lullaby group (NG) (n=40), mixed music group (MG) (n=40) or control group (CG) (n=40) by simple randomization method. The statistician randomized the participants to intervention groups or control groups with the computer program "Quickcalcs graph pad" (http://www.graphpad.com/quickcalcs/, Accessed: 28.07.2021). Participants were grouped according to the randomization list according to the order of admission to the obstetrics clinic.

Necessary information about the study was given to the pregnant women who were suitable and willing to participate in the study. These pregnant women were randomly assigned to one of three groups after taking their written consent. There were two experimental and one control group in the study. One of the experimental group was a lullaby group and the other was a mixed music group. The control group did not listen to music, did not receive any intervention, received routine general care only during hospital visits.

First of all, sociodemographic and obstetric data of the pregnant women were collected, and their anxiety and stress levels were evaluated at the beginning of the study (pretest) and after 2 weeks of music intervention/general care (posttest). These data were collected at the hospital when pregnant women came to their pregnancy follow-ups.

Music initiatives (lullaby group and mixed music group):

The pregnant women in the lullaby group were told to listen only to the lullaby recording chosen by the researcher for 30 minutes a day for 2 weeks at home. Various music recordings consisting of "nature sounds, classical western music, Turkish music and lullaby" recordings prepared by the researchers were sent to the Mixed music group, and they were told to choose and listen to any of these recordings for 30 minutes a day for 2 weeks. Consultancy was received from a lecturer in the Musicology department regarding these music recordings. The music recordings were sent to the pregnant women through the mobile communication application (telegram, whatsapp, etc.) so that they could listen to them on their own phones, and they were asked to download/save the music recordings on their phones.

All pregnant women who were going to have a music attempt were informed about the way and conditions of listening to music at home. Based on previous studies, a guide to listening to music at home during pregnancy was developed. Accordingly, lullabies and other musical genres mentioned were used, with a slow rhythm (ranging between 60-70 beats per minute when measured with a metronome) and soft melody compatible with the normal heart rate. It was reported that pregnant women should use their own headphones in a quiet and poorly lit room to avoid being affected by ambient sounds while listening to music, they should prefer and adjust the volume of the music before listening, empty their bladder and not be hungry. The situation of performing these music attempts at home was followed up by the researcher by talking to the pregnant women on the phone every day. Researchers and participants were not blinded to the study due to the nature of the music enterprise. During the study, the routine care and follow-up of the pregnant women was not interfered with.

The data on the sociodemographic and obstetric characteristics of the pregnant women were collected with the personal information form created by the researchers in line with the literature. Anxiety and antenatal stress, which are the primary results of the study, were evaluated with the "State-Trait Anxiety Inventory" and the "Perceived Prenatal Stress Scale".

Data were evaluated using the IBM SPSS v.23 (IBM Corp. Armonk, NY, USA) program. Data were presented with descriptive statistics such as number, percentage, arithmetic mean, standard deviation. Chi-square test was used for categorical variables, and One way variance analysis (ANOVA) for the continuous variables to confirm differences in sociodemographic and obstetrics characteristics between the groups. The scores of the STAI and APSI between groups were compared using One way variance analysis (ANOVA) and Tukey test, for comparison within groups was used Paired samples t-test. Statistical significance value was accepted as p<0.05.

This study has some limitations and difficulties. The first of these; Since it is a single-center study, its results cannot be generalized to all healthy pregnant women. Latter; The long-term effectiveness of lullabies or other music concerts cannot be evaluated, since no follow-up was made during the pregnancy and postpartum period after the music attempt in the study. Third; The fact that pregnant women are asked to listen to music at home and that it is followed by phone makes it difficult to fully implement the intervention in terms of duration and conditions.

Being tested
listening to lullabies or self-selected music
Medical subject headings
Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • listening to lullabies or self-selected musicOther

    listening to lullabies for lullaby group and listening to music of their choice among various music for mix music group

Study groups in NCT05221489
Study groupRoleWhat they receive
lullaby groupExperimentalFor two weeks and 30 minutes every day at home, the lullaby group (LG) only listened to the lullaby record selected by the researcher.
Receives: Other: listening to lullabies or self-selected music
mix music groupExperimentalFor two weeks and 30 minutes every day at home, the multi-music group (MG) listened to self-selected music from different records presented to them by the researcher.
Receives: Other: listening to lullabies or self-selected music
control groupNo interventionThe control group (CG) only received routine care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anxiety change at 2 weeks

    As assessed by the State-Trait Anxiety Inventory

    Measured: At baseline and at the end of the 2nd week of study, anxiety was assessed.

  2. Prenatal stress change at 2 weeks

    As assessed by the antenatal perceived stress inventory

    Measured: At baseline and at the end of the 2nd week of study, prenatal stress was assessed.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2022
  2. Study start25 Aug 2021
  3. Primary completion15 Dec 2021
  4. Study completion15 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05221489
Sponsor's protocol ID
368
Status last verified
Jan 2022
First submitted
13 Jan 2022
Last updated
3 Feb 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The data that support the findings of this study are available from the corresponding author (N.B. or Ö.D.Y.) upon reasonable request.

Questions about this trial

What is this clinical trial studying?

A study testing listening to lullabies or self-selected music in people with Anxiety, Stress-Related, in Pregnancy, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anxiety change at 2 weeks (time frame: At baseline and at the end of the 2nd week of study, anxiety was assessed.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.

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