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).
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
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.
- Conditions
- Anxiety, Stress-Related, in Pregnancy
- 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 group | Role | What they receive |
|---|---|---|
| lullaby group | Experimental | For 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 group | Experimental | For 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 group | No intervention | The control group (CG) only received routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
- First posted3 Feb 2022
- Study start25 Aug 2021
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety, Stress-Related, in PregnancyStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Collaborators
- Firat University
- Responsible party
- Principal investigator, Nazlı Baltacı, Ondokuz Mayıs University
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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05221489
- Acronym / sponsor ID
- 368
- Conditions
- Anxiety, Stress-Related, in Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Collaborators
- Firat University
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lullaby group | Experimental | Other: listening to lullabies or self-selected musicFor two weeks and 30 minutes every day at home, the lullaby group (LG) only listened to the lullaby record selected by the researcher. |
| mix music group | Experimental | Other: listening to lullabies or self-selected musicFor 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. |
| control group | No intervention | –The control group (CG) only received routine care. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Willing to participate
- Healthy
- 19 years and older
- 36th and above gestational week
- Nulliparous
Key exclusion criteria (9 listed)
- Unwilling to participate
- Having a risky pregnancy
- Below the 36th gestational week
- Multiparous
- Fetal anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| listening to lullabies or self-selected musiclistening to lullabies for lullaby group and listening to music of their choice among various music for mix music group | Other | lullaby group, mix music group |
Primary outcome
Anxiety change at 2 weeks
Time frame: At baseline and at the end of the 2nd week of study, anxiety was assessed.
As assessed by the State-Trait Anxiety Inventory
Prenatal stress change at 2 weeks
Time frame: At baseline and at the end of the 2nd week of study, prenatal stress was assessed.
As assessed by the antenatal perceived stress inventory
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.