AnxietyNCT04064320
The Effect of Lullaby Intervention on Anxiety and Attachment in Pregnancy
A study testing Lullaby intervention in people with Anxiety and Attachment Disorder, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
The aim of present study was to investigate the effect of lullaby intervention on anxiety and prenatal attachment in women with high-risk pregnancy. The study involved women with high-risk pregnancy who were assigned randomly to the intervention (n=30) or control (n=30) groups in a state hospital in Turkey. 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, Attachment Disorder, Pregnancy Related
- What is being tested?
- Lullaby intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2017to 5 Dec 2018
- 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
- Hospitalization due to high-risk pregnancy
- 19 years and older
- Pregnancy duration longer than 28 weeks.
- Singleton pregnancy.
- Duration of hospitalization 24 hours minimum.
- Ability to read and write and to comprehend.
- Speaking Turkish.
Who cannot join
- Hospital admission due to severe preeclampsia, eclampsia or ablatio placenta.
- Presence of mental or cognitive disorders.
- Being under psychiatric treatment.
- Vision or hearing impairments.
- Fetal deformity or anomalies such as congenital diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ondokuz Mayıs University, Faculty of Health Sciences
Samsun, 55200
About this study
Official title: The Effect of Lullaby Intervention on Anxiety and Prenatal Attachment in Women With High-risk Pregnancy: A Randomised Controlled Study
The aim of present study was to investigate the effect of lullaby intervention on anxiety and prenatal attachment in women with high-risk pregnancy. The study involved women with high-risk pregnancy who were assigned randomly to the intervention (n=30) or control (n=30) groups in a state hospital in Turkey. For two successive days, the intervention group listened to lullabies for 20 minutes once a day, meanwhile touched the abdomen and thought about their babies, but the control group did not. Data from the outcomes of anxiety and attachment were collected at baseline and at the end of the second day. Vital findings were measured on each study day, both before and after the lullaby intervention/usual care.
Read the detailed description
Women with high-risk pregnancy may experience anxiety and low prenatal attachment due to many problems with pregnancy and hospitalization. It is reported that anxiety can have negative effects on prenatal attachment. The anxiety during pregnancy may adversely affect the health of the pregnant woman and fetus.
During the study period, 777 pregnant women were admitted to the clinic and 125 of them with high-risk pregnancy were assessed for eligibility for the study on 2 days a week. The pregnant women (n=76) who met the inclusion criteria and agreed to participate in the study were recruited. Participants were randomized in equal numbers to the intervention (n=38) and control groups (n=38) by withdrawing computer randomized sampling numbers (using Microsoft Excel 2010) from concealed envelopes to determine their group status. Participants were numbered according to their order of admittance to the hospital. After obtaining informed content and collecting baseline data, main researcher randomly chose one code for each woman. Data was collected together until the sample size was reached.
Participants were recruited by simple random sampling from the perinatology clinic at a state hospital in Turkey. An estimation of sample size was calculated at an effect size of 2.43 with a 5% level of significance on the primary outcome of anxiety in a sample study. According to G*power 3.1 31, each group required 30 participants. During the study, 125 women were assessed for eligibility, 49 of them were excluded. Some participants withdrew due to preterm birth (n=5), referral to another hospital (n=1) or discharged from hospital (n=10). Finally 60 participants who completed the lullaby intervention were included in data analysis. As a result of the study, the power of the test (α=0.05, 95% confidence interval) was 99.9% for each group n=30.
The preliminary study included five women at risk of preterm delivery who met the inclusion criteria. They were subjected to a lullaby intervention, and their study variables were evaluated. The women in the preliminary study were not included in the main study.
The IG listened to lullabies, and accompanied by lullabies touched their abdomen and thought about their babies. The CG received only the usual care of the hospital.
The lullaby recital consisted of 10 different lullabies with a mean duration of two minutes, for a total of 20 minutes.The lullabies were among the best-known ones from the Turkish culture. At the place of study, an academician of the Music Education Department of the University, Fine Arts Faculty was consulted regarding the lullaby recital.The pregnant women in the intervention group listened to the lullabies for 20 minutes per day, for two successive days using an MP3 player. To provide a homogeneous intervention and to avoid bias, the personal lullaby preferences of the pregnant women were ignored.
This intervention was performed in single patient rooms during bed rest, when the participants were available and felt ready. The doors and windows of the room was closed, and the participants were left alone. A disposable ear-tip was used for each participant. Before the initiation of the recital, the MP3 player was checked and the participants were instructed in the operation of the MP3 player (turning on, turning off, adjusting volume). The tempo of the lullaby was concordant with the normal heart rate (about 60-70 beats per minute), the participant determined and adjusted the volume to suit.
The control group received only the usual care of the hospital, resting in reclined position. All of the participants in both groups were ensured to have empty bladders and closed their cellphones, and none received any medical interventions during the lullaby intervention/usual care.
The study data was collected between 11:30 and 13:30 after lunch when no medical care, diagnostic tests or routine follow-up were administered. Initially, sociodemographic and obstetric data were collected by face-to-face interviews with participants. Intervention effect outcomes were anxiety and attachment which were measured at baseline. Anxiety was measured by the State-Trait Anxiety Inventory (STAI) and attachment was measured by the Prenatal Attachment Inventory (PAI). Before pregnant women filled the STAI and PAI, the instructions were read aloud to them and then they responded the questionnaires in silence. The STAI and PAI were reassessed at the end of the study (day 2) after the lullaby intervention/usual care. Vital findings were also measured on each study day, both before and after the lullaby intervention/usual care. The systolic and diastolic blood pressures and pulse rates of all participants were measured using a digital sphygmomanometer. The respiratory rate was measured by observing the chest and count the number of respirations out loud for one full minute using a digital watch while at bed rest (the same device was used for each participant). The level of satisfaction with listening to lullabies was assessed after the lullaby intervention at the end of the study using a 10-point Likert-type scale.
After the purposes and procedures of this study was explained, signed informed consent was obtained from all participants. Participants were assured of privacy and that their identity was protected. The study was based on voluntariness. Usual care and treatment of pregnant women in each groups were not intervened during the study period.
Data were analyzed by IBM SPSS v.23. Categorical data were analysed using the chi-square test for homogeneity of characteristics between two groups. Parametric tests were used if the data was normally distributed, but if not, nonparametric tests were used. A Pearson Chi-square test, Fisher's exact test, and Yates' continuity correction were used to compare the categorical data. The continuous data was compared using a Student's t or Mann-Whitney U-tests. A Paired sample t-test or Wilcoxon Signed Rank test were used to compare the paired scores of the STAI and PAI and the vital findings within the groups. The relationship between these three parameters was analyzed using a Spearman-correlation test. Statistical significance was considered p<0.05.
There are also some limitations in this study. Firstly, only state anxiety of the pregnant women was assessed, and future studies would benefit from taking also trait anxiety into consideration. It was a single-center study; therefore, the generalizability of the results to other women with high-risk pregnancy is unclear. Since the perinatology clinic where the study was carried out was newly opened, there were some disruptions and most pregnant women were transferred from this clinic to other clinics of hospital and discharged from hospital before the required hospital stay; therefore, the study could only be performed with pregnant women hospitalized for 3 days.
- Conditions
- Anxiety, Attachment Disorder, Pregnancy Related
- Being tested
- Lullaby intervention
- Keywords
- pregnancy, high-risk, anxiety, prenatal attachment, bonding, lullaby, 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.
Lullaby interventionBehavioural
Listening to lullabies, and accompanied by lullabies touching their abdomen and think about their babies of hospitalized women with high-risk pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Received lullaby intervention and usual care Receives: Behavioral: Lullaby intervention |
| Control group | No intervention | No intervention other than usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety change
As assessed by the State-Trait Anxiety Inventory (STAI) STAI consists of two scales, a total of 40 self-reported items. The State Anxiety Scale only used in this study, consists of 20 straight and inverse scored terms, and is scored between 20 and 80 in a likert type scoring between 1 and 4. High scores indicate high anxiety levels.
Measured: At baseline and at the end of the 2nd day of study, anxiety was assessed.
Prenatal attachment change
As assessed by the Prenatal Attachment Inventory (PAI) PAI which is a likert type scale, has 21-item with four scores (1-4) and the total score is 21-84. A higher scores indicate higher levels of attachment.
Measured: At baseline and at the end of the 2nd day of study, prenatal attachment was assessed.
Secondary outcomes (4)
Change in Respiratory Rate
The respiratory rate was measured by observing the chest and count the number of respirations out loud for one full minute using a digital watch while at bed rest. One respiration consists of one complete rise and fall of the chest (inhalation and exhalation of air).
Measured: At 1st day of study before intervention/usual care, at 1st day of study after intervention/usual care, at 2nd day before intervention/usual care and at 2nd day after intervention/usual care
Change in Heart Rate
The heart rate was measured using a digital sphygmomanometer.
Measured: At 1st day of study before intervention/usual care, at 1st day of study after intervention/usual care, at 2nd day before intervention/usual care and at 2nd day after intervention/usual care
Change in Systolic Blood Pressure
The systolic blood pressure was measured using a digital sphygmomanometer and recorded in mmHg.
Measured: At 1st day of study before intervention/usual care, at 1st day of study after intervention/usual care, at 2nd day before intervention/usual care and at 2nd day after intervention/usual care
Change in Diastolic Blood Pressure
The diastolic blood pressure was measured using a digital sphygmomanometer and recorded in mmHg.
Measured: At 1st day of study before intervention/usual care, at 1st day of study after intervention/usual care, at 2nd day before intervention/usual care and at 2nd day after intervention/usual care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start6 Jun 2017
- Primary completion1 Dec 2017
- Study completion5 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- None (open label)
- Enrolment
- 76 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, Assistant Professor phDMürüvvet Başer, Professor, Study director, Erciyes University, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064320
- Sponsor's protocol ID
- 363
- Status last verified
- Nov 2020
- First submitted
- 10 Aug 2019
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arabin B, Jahn M. "Need for interventional studies on the impact of music in the perinatal period: results of a pilot study on women's preferences and review of the literature". J Matern Fetal Neonatal Med. 2013 Mar;26(4):357-62. doi: 10.3109/14767058.2012.733763. Epub 2012 Nov 1.
PubMed 23039049Bauer CL, Victorson D, Rosenbloom S, Barocas J, Silver RK. Alleviating distress during antepartum hospitalization: a randomized controlled trial of music and recreation therapy. J Womens Health (Larchmt). 2010 Mar;19(3):523-31. doi: 10.1089/jwh.2008.1344.
PubMed 20141383Arranz Betegon A, Garcia M, Pares S, Montenegro G, Feixas G, Padilla N, Camacho A, Goberna J, Botet F, Gratacos E. A Program Aimed at Reducing Anxiety in Pregnant Women Diagnosed With a Small-for-Gestational-Age Fetus: Evaluative Findings From a Spanish Study. J Perinat Neonatal Nurs. 2017 Jul/Sep;31(3):225-235. doi: 10.1097/JPN.0000000000000270.
PubMed 28737543Carolan-Olah M, Barry M. Antenatal stress: an Irish case study. Midwifery. 2014 Mar;30(3):310-6. doi: 10.1016/j.midw.2013.03.014. Epub 2013 May 16.
PubMed 23684696Carolan M, Barry M, Gamble M, Turner K, Mascarenas O. The Limerick Lullaby project: an intervention to relieve prenatal stress. Midwifery. 2012 Apr;28(2):173-80. doi: 10.1016/j.midw.2010.12.006. Epub 2011 Mar 3.
PubMed 21371795Carolan M, Barry M, Gamble M, Turner K, Mascarenas O. Experiences of pregnant women attending a lullaby programme in Limerick, Ireland: a qualitative study. Midwifery. 2012 Jun;28(3):321-8. doi: 10.1016/j.midw.2011.04.009. Epub 2011 Jun 8.
PubMed 21641704Chang MY, Chen CH, Huang KF. Effects of music therapy on psychological health of women during pregnancy. J Clin Nurs. 2008 Oct;17(19):2580-7. doi: 10.1111/j.1365-2702.2007.02064.x. Epub 2008 Feb 19.
PubMed 18298503Chang HC, Yu CH, Chen SY, Chen CH. The effects of music listening on psychosocial stress and maternal-fetal attachment during pregnancy. Complement Ther Med. 2015 Aug;23(4):509-15. doi: 10.1016/j.ctim.2015.05.002. Epub 2015 May 27.
PubMed 26275644Corbijn van Willenswaard K, Lynn F, McNeill J, McQueen K, Dennis CL, Lobel M, Alderdice F. Music interventions to reduce stress and anxiety in pregnancy: a systematic review and meta-analysis. BMC Psychiatry. 2017 Jul 27;17(1):271. doi: 10.1186/s12888-017-1432-x.
PubMed 28750631Ding XX, Wu YL, Xu SJ, Zhu RP, Jia XM, Zhang SF, Huang K, Zhu P, Hao JH, Tao FB. Maternal anxiety during pregnancy and adverse birth outcomes: a systematic review and meta-analysis of prospective cohort studies. J Affect Disord. 2014 Apr;159:103-10. doi: 10.1016/j.jad.2014.02.027. Epub 2014 Feb 26.
PubMed 24679397Dipietro JA. Psychological and psychophysiological considerations regarding the maternal-fetal relationship. Infant Child Dev. 2010;19(1):27-38. doi: 10.1002/icd.651.
PubMed 20228872Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Garcia Gonzalez J, Ventura Miranda MI, Manchon Garcia F, Pallares Ruiz TI, Marin Gascon ML, Requena Mullor M, Alarcon Rodriguez R, Parron Carreno T. Effects of prenatal music stimulation on fetal cardiac state, newborn anthropometric measurements and vital signs of pregnant women: A randomized controlled trial. Complement Ther Clin Pract. 2017 May;27:61-67. doi: 10.1016/j.ctcp.2017.03.004. Epub 2017 Apr 1.
PubMed 28438283Garcia-Gonzalez J, Ventura-Miranda MI, Requena-Mullor M, Parron-Carreno T, Alarcon-Rodriguez R. State-trait anxiety levels during pregnancy and foetal parameters following intervention with music therapy. J Affect Disord. 2018 May;232:17-22. doi: 10.1016/j.jad.2018.02.008. Epub 2018 Feb 13.
PubMed 29471206Julian LJ. Measures of anxiety: State-Trait Anxiety Inventory (STAI), Beck Anxiety Inventory (BAI), and Hospital Anxiety and Depression Scale-Anxiety (HADS-A). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S467-72. doi: 10.1002/acr.20561. No abstract available.
PubMed 22588767
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lullaby Intervention on Anxiety and Prenatal Attachment in Women With High-risk Pregnancy: A Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT04064320
- Acronym / sponsor ID
- 363
- Conditions
- Anxiety, Attachment Disorder, Pregnancy Related
- Keywords
- pregnancy, high-risk, anxiety, prenatal attachment, bonding, lullaby, music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 5 Dec 2018 (actual)
- First posted
- 21 Aug 2019 (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 aim of present study was to investigate the effect of lullaby intervention on anxiety and prenatal attachment in women with high-risk pregnancy. The study involved women with high-risk pregnancy who were assigned randomly to the intervention (n=30) or control (n=30) groups in a state hospital in Turkey. For two successive days, the intervention group listened to lullabies for 20 minutes once a day, meanwhile touched the abdomen and thought about their babies, but the control group did not. Data from the outcomes of anxiety and attachment were collected at baseline and at the end of the second day. Vital findings were measured on each study day, both before and after the lullaby intervention/usual care.
Detailed description
Women with high-risk pregnancy may experience anxiety and low prenatal attachment due to many problems with pregnancy and hospitalization. It is reported that anxiety can have negative effects on prenatal attachment. The anxiety during pregnancy may adversely affect the health of the pregnant woman and fetus.
During the study period, 777 pregnant women were admitted to the clinic and 125 of them with high-risk pregnancy were assessed for eligibility for the study on 2 days a week. The pregnant women (n=76) who met the inclusion criteria and agreed to participate in the study were recruited. Participants were randomized in equal numbers to the intervention (n=38) and control groups (n=38) by withdrawing computer randomized sampling numbers (using Microsoft Excel 2010) from concealed envelopes to determine their group status. Participants were numbered according to their order of admittance to the hospital. After obtaining informed content and collecting baseline data, main researcher randomly chose one code for each woman. Data was collected together until the sample size was reached.
Participants were recruited by simple random sampling from the perinatology clinic at a state hospital in Turkey. An estimation of sample size was calculated at an effect size of 2.43 with a 5% level of significance on the primary outcome of anxiety in a sample study. According to G*power 3.1 31, each group required 30 participants. During the study, 125 women were assessed for eligibility, 49 of them were excluded. Some participants withdrew due to preterm birth (n=5), referral to another hospital (n=1) or discharged from hospital (n=10). Finally 60 participants who completed the lullaby intervention were included in data analysis. As a result of the study, the power of the test (α=0.05, 95% confidence interval) was 99.9% for each group n=30.
The preliminary study included five women at risk of preterm delivery who met the inclusion criteria. They were subjected to a lullaby intervention, and their study variables were evaluated. The women in the preliminary study were not included in the main study.
The IG listened to lullabies, and accompanied by lullabies touched their abdomen and thought about their babies. The CG received only the usual care of the hospital.
The lullaby recital consisted of 10 different lullabies with a mean duration of two minutes, for a total of 20 minutes.The lullabies were among the best-known ones from the Turkish culture. At the place of study, an academician of the Music Education Department of the University, Fine Arts Faculty was consulted regarding the lullaby recital.The pregnant women in the intervention group listened to the lullabies for 20 minutes per day, for two successive days using an MP3 player. To provide a homogeneous intervention and to avoid bias, the personal lullaby preferences of the pregnant women were ignored.
This intervention was performed in single patient rooms during bed rest, when the participants were available and felt ready. The doors and windows of the room was closed, and the participants were left alone. A disposable ear-tip was used for each participant. Before the initiation of the recital, the MP3 player was checked and the participants were instructed in the operation of the MP3 player (turning on, turning off, adjusting volume). The tempo of the lullaby was concordant with the normal heart rate (about 60-70 beats per minute), the participant determined and adjusted the volume to suit.
The control group received only the usual care of the hospital, resting in reclined position. All of the participants in both groups were ensured to have empty bladders and closed their cellphones, and none received any medical interventions during the lullaby intervention/usual care.
The study data was collected between 11:30 and 13:30 after lunch when no medical care, diagnostic tests or routine follow-up were administered. Initially, sociodemographic and obstetric data were collected by face-to-face interviews with participants. Intervention effect outcomes were anxiety and attachment which were measured at baseline. Anxiety was measured by the State-Trait Anxiety Inventory (STAI) and attachment was measured by the Prenatal Attachment Inventory (PAI). Before pregnant women filled the STAI and PAI, the instructions were read aloud to them and then they responded the questionnaires in silence. The STAI and PAI were reassessed at the end of the study (day 2) after the lullaby intervention/usual care. Vital findings were also measured on each study day, both before and after the lullaby intervention/usual care. The systolic and diastolic blood pressures and pulse rates of all participants were measured using a digital sphygmomanometer. The respiratory rate was measured by observing the chest and count the number of respirations out loud for one full minute using a digital watch while at bed rest (the same device was used for each participant). The level of satisfaction with listening to lullabies was assessed after the lullaby intervention at the end of the study using a 10-point Likert-type scale.
After the purposes and procedures of this study was explained, signed informed consent was obtained from all participants. Participants were assured of privacy and that their identity was protected. The study was based on voluntariness. Usual care and treatment of pregnant women in each groups were not intervened during the study period.
Data were analyzed by IBM SPSS v.23. Categorical data were analysed using the chi-square test for homogeneity of characteristics between two groups. Parametric tests were used if the data was normally distributed, but if not, nonparametric tests were used. A Pearson Chi-square test, Fisher's exact test, and Yates' continuity correction were used to compare the categorical data. The continuous data was compared using a Student's t or Mann-Whitney U-tests. A Paired sample t-test or Wilcoxon Signed Rank test were used to compare the paired scores of the STAI and PAI and the vital findings within the groups. The relationship between these three parameters was analyzed using a Spearman-correlation test. Statistical significance was considered p<0.05.
There are also some limitations in this study. Firstly, only state anxiety of the pregnant women was assessed, and future studies would benefit from taking also trait anxiety into consideration. It was a single-center study; therefore, the generalizability of the results to other women with high-risk pregnancy is unclear. Since the perinatology clinic where the study was carried out was newly opened, there were some disruptions and most pregnant women were transferred from this clinic to other clinics of hospital and discharged from hospital before the required hospital stay; therefore, the study could only be performed with pregnant women hospitalized for 3 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Lullaby interventionReceived lullaby intervention and usual care |
| Control group | No intervention | –No intervention other than usual care |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Hospitalization due to high-risk pregnancy
- 19 years and older
- Pregnancy duration longer than 28 weeks.
- Singleton pregnancy.
- Duration of hospitalization 24 hours minimum.
Key exclusion criteria (5 listed)
- Hospital admission due to severe preeclampsia, eclampsia or ablatio placenta.
- Presence of mental or cognitive disorders.
- Being under psychiatric treatment.
- Vision or hearing impairments.
- Fetal deformity or anomalies such as congenital diseases
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 |
|---|---|---|
| Lullaby interventionListening to lullabies, and accompanied by lullabies touching their abdomen and think about their babies of hospitalized women with high-risk pregnancy | Behavioural | Intervention group |
Primary outcome
Anxiety change
Time frame: At baseline and at the end of the 2nd day of study, anxiety was assessed.
As assessed by the State-Trait Anxiety Inventory (STAI) STAI consists of two scales, a total of 40 self-reported items. The State Anxiety Scale only used in this study, consists of 20 straight and inverse scored terms, and is scored between 20 and 80 in a likert type scoring between 1 and 4. High scores indicate high anxiety levels.
Prenatal attachment change
Time frame: At baseline and at the end of the 2nd day of study, prenatal attachment was assessed.
As assessed by the Prenatal Attachment Inventory (PAI) PAI which is a likert type scale, has 21-item with four scores (1-4) and the total score is 21-84. A higher scores indicate higher levels of attachment.
4 secondary outcomes
Change in Respiratory Rate
Time frame: At 1st day of study before intervention/usual care, at 1st day of study after intervention/usual care, at 2nd day before intervention/usual care and at 2nd day after intervention/usual care
Change in Heart Rate
Time frame: At 1st day of study before intervention/usual care, at 1st day of study after intervention/usual care, at 2nd day before intervention/usual care and at 2nd day after intervention/usual care
Change in Systolic Blood Pressure
Time frame: At 1st day of study before intervention/usual care, at 1st day of study after intervention/usual care, at 2nd day before intervention/usual care and at 2nd day after intervention/usual care
Change in Diastolic Blood Pressure
Time frame: At 1st day of study before intervention/usual care, at 1st day of study after intervention/usual care, at 2nd day before intervention/usual care and at 2nd day after intervention/usual care
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 6 Nov 2020.
- Background: PubMed 23039049Arabin B, Jahn M. "Need for interventional studies on the impact of music in the perinatal period: results of a pilot study on women's preferences and review of the literature". J Matern Fetal Neonatal Med. 2013 Mar;26(4):357-62. doi: 10.3109/14767058.2012.733763. Epub 2012 Nov 1.
- Background: PubMed 20141383Bauer CL, Victorson D, Rosenbloom S, Barocas J, Silver RK. Alleviating distress during antepartum hospitalization: a randomized controlled trial of music and recreation therapy. J Womens Health (Larchmt). 2010 Mar;19(3):523-31. doi: 10.1089/jwh.2008.1344.
- Background: PubMed 28737543Arranz Betegon A, Garcia M, Pares S, Montenegro G, Feixas G, Padilla N, Camacho A, Goberna J, Botet F, Gratacos E. A Program Aimed at Reducing Anxiety in Pregnant Women Diagnosed With a Small-for-Gestational-Age Fetus: Evaluative Findings From a Spanish Study. J Perinat Neonatal Nurs. 2017 Jul/Sep;31(3):225-235. doi: 10.1097/JPN.0000000000000270.
- Background: PubMed 23684696Carolan-Olah M, Barry M. Antenatal stress: an Irish case study. Midwifery. 2014 Mar;30(3):310-6. doi: 10.1016/j.midw.2013.03.014. Epub 2013 May 16.
- Background: PubMed 21371795Carolan M, Barry M, Gamble M, Turner K, Mascarenas O. The Limerick Lullaby project: an intervention to relieve prenatal stress. Midwifery. 2012 Apr;28(2):173-80. doi: 10.1016/j.midw.2010.12.006. Epub 2011 Mar 3.
- Background: PubMed 21641704Carolan M, Barry M, Gamble M, Turner K, Mascarenas O. Experiences of pregnant women attending a lullaby programme in Limerick, Ireland: a qualitative study. Midwifery. 2012 Jun;28(3):321-8. doi: 10.1016/j.midw.2011.04.009. Epub 2011 Jun 8.
- Background: PubMed 18298503Chang MY, Chen CH, Huang KF. Effects of music therapy on psychological health of women during pregnancy. J Clin Nurs. 2008 Oct;17(19):2580-7. doi: 10.1111/j.1365-2702.2007.02064.x. Epub 2008 Feb 19.
- Background: PubMed 26275644Chang HC, Yu CH, Chen SY, Chen CH. The effects of music listening on psychosocial stress and maternal-fetal attachment during pregnancy. Complement Ther Med. 2015 Aug;23(4):509-15. doi: 10.1016/j.ctim.2015.05.002. Epub 2015 May 27.
- Background: PubMed 28750631Corbijn van Willenswaard K, Lynn F, McNeill J, McQueen K, Dennis CL, Lobel M, Alderdice F. Music interventions to reduce stress and anxiety in pregnancy: a systematic review and meta-analysis. BMC Psychiatry. 2017 Jul 27;17(1):271. doi: 10.1186/s12888-017-1432-x.
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- 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, Assistant Professor phD
Mürüvvet Başer, Professor study director
Erciyes University, Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lullaby intervention in people with Anxiety and Attachment Disorder, 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 7 inclusion and 5 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 6 Nov 2020. 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 (time frame: At baseline and at the end of the 2nd day 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?
On the ClinicalTrials.gov record for NCT04064320, which also lists 24 linked publications.
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 6 Nov 2020.