Psychological DistressNCT05228392
The Effects of Listening to Lullabies and Self-selected Music on Distress and Maternal Attachment in Pregnant Women
A study testing listening to music in people with Psychological Distress and Bonding, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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. 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
- Psychological Distress, Bonding
- What is being tested?
- listening to music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jun 2021to 15 Oct 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
- Agreeing to participate in the study
- Being 19 years old or older,
- Being in the third trimester of pregnancy
- Having a singleton pregnancy
- Not having any fetal anomaly
- Being literate
Show all 9Show fewer
- Using a mobile communication application (e.g., Telegram, WhatsApp)
- Not having a psychiatric disorder
- Being able to communicate in Turkish.
Who cannot join
- Not agreeing to participate
- Having a risky pregnancy
- Being in the first or second trimester of pregnancy
- Having a multiple pregnancy
- Having a fetal anomaly
- Having a mental, cognitive, psychiatric, auditory or visual disorder or impairment
Show all 9Show fewer
- Being illiterate
- Not using a mobile communication application (e.g., Telegram, WhatsApp)
- Not being able to communicate in Turkish.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun Training and Research Hospital, Obstetrics and Gynecology Clinic, Gynecology and Obstetrics Polyclinics
Samsun
About this study
Official title: The Effects of Listening to Lullabies and Self-selected Music on Distress and Maternal Attachment in Pregnant Women: A Randomized-controlled Study
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.
Read the detailed 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.
- Conditions
- Psychological Distress, Bonding
- Being tested
- listening to music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
listening to musicOther
listening to lullaby or other music types
| 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 music |
| multi 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 music |
| control group | No intervention | The control group (CG) only received routine care. This group do not listened to music. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological bonding change
As assessed by the "Maternal Antenatal Attachment Scale" (MAAS) developed by Condon (1993).Each item of the scale, which consists of a total of 19 items, focuses on the feelings, attitudes and behaviors of the pregnant woman towards her fetus. The minimum and maximum total scores of the scale are 19 and 95. Higher scores show higher levels of prenatal maternal attachment.
Measured: At baseline and at the end of the 2nd week of study, psychological bonding was assessed.
Psychological distress change
As assessed by the "Prenatal Distress Questionnaire" (NuPDQ) that was developed by Yali and Lobel (1999). This 3-point Likert-type scale consisting of 17 items in total determines physical and emotional symptoms that could arise in pregnancy, relevant relationships, problems or concerns experienced in issues associated with motherhood, body image and pregnancy. The pregnancy-specific distress experienced in the pregnancy period is scored by summing the scores of the respondent in all items. The minimum and maximum total scores of the scale are 0 and 34. Higher scores are interpreted as higher levels of prenatal distress.
Measured: At baseline and at the end of the 2nd week of study, psychological distress was assessed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start16 Jun 2021
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies 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
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazlı Baltacı, Ondokuz Mayıs University
- Investigators
- Nazlı Baltacı, phD, Principal investigator, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228392
- Sponsor's protocol ID
- 365
- Status last verified
- Jan 2022
- First submitted
- 12 Jan 2022
- Last updated
- 8 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baltaci N, Koc E, Dogan Yuksekol O, Cokyeter B. The Effects of Listening to Lullabies and Self-selected Music on Distress and Maternal Attachment in Pregnant Women: A Randomized Controlled Study. Altern Ther Health Med. 2023 Oct;29(7):46-51.
PubMed 36399083
Study at a glance
From the registry record, last updated by the sponsor on 8 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 on Distress and Maternal Attachment in Pregnant Women: A Randomized-controlled Study
- ClinicalTrials.gov ID
- NCT05228392
- Acronym / sponsor ID
- 365
- Conditions
- Psychological Distress, Bonding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 8 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.
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.
Detailed 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.
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 musicFor two weeks and 30 minutes every day at home, the lullaby group (LG) only listened to the lullaby record selected by the researcher |
| multi music group | Experimental | Other: listening to 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. This group do not listened to music. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Agreeing to participate in the study
- Being 19 years old or older,
- Being in the third trimester of pregnancy
- Having a singleton pregnancy
- Not having any fetal anomaly
Key exclusion criteria (9 listed)
- Not agreeing to participate
- Having a risky pregnancy
- Being in the first or second trimester of pregnancy
- Having a multiple pregnancy
- Having a 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 musiclistening to lullaby or other music types | Other | lullaby group, multi music group |
Primary outcome
Psychological bonding change
Time frame: At baseline and at the end of the 2nd week of study, psychological bonding was assessed.
As assessed by the "Maternal Antenatal Attachment Scale" (MAAS) developed by Condon (1993).Each item of the scale, which consists of a total of 19 items, focuses on the feelings, attitudes and behaviors of the pregnant woman towards her fetus. The minimum and maximum total scores of the scale are 19 and 95. Higher scores show higher levels of prenatal maternal attachment.
Psychological distress change
Time frame: At baseline and at the end of the 2nd week of study, psychological distress was assessed.
As assessed by the "Prenatal Distress Questionnaire" (NuPDQ) that was developed by Yali and Lobel (1999). This 3-point Likert-type scale consisting of 17 items in total determines physical and emotional symptoms that could arise in pregnancy, relevant relationships, problems or concerns experienced in issues associated with motherhood, body image and pregnancy. The pregnancy-specific distress experienced in the pregnancy period is scored by summing the scores of the respondent in all items. The minimum and maximum total scores of the scale are 0 and 34. Higher scores are interpreted as higher levels of prenatal distress.
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 8 Feb 2022.
- Derived from this study: PubMed 36399083Baltaci N, Koc E, Dogan Yuksekol O, Cokyeter B. The Effects of Listening to Lullabies and Self-selected Music on Distress and Maternal Attachment in Pregnant Women: A Randomized Controlled Study. Altern Ther Health Med. 2023 Oct;29(7):46-51.
- Individual participant dataSharing planned: No
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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.
Nazlı Baltacı, phD principal investigator
Ondokuz Mayıs University
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 music in people with Psychological Distress and Bonding, 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 9 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 8 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?
Psychological bonding change (time frame: At baseline and at the end of the 2nd week of study, psychological bonding 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?
On the ClinicalTrials.gov record for NCT05228392, which also lists 1 linked publication.
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 8 Feb 2022.