Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

The Effect of Lullaby Intervention on Anxiety and Attachment in Pregnancy

4 novembre 2020 aggiornato da: Nazlı Baltacı, Ondokuz Mayıs University

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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

76

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Samsun, Tacchino, 55200
        • Ondokuz Mayıs University, Faculty of Health Sciences

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

19 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Intervention group
Received lullaby intervention and usual care
Listening to lullabies, and accompanied by lullabies touching their abdomen and think about their babies of hospitalized women with high-risk pregnancy
Nessun intervento: Gruppo di controllo
Nessun intervento oltre alle solite cure

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Anxiety change
Lasso di tempo: 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.
At baseline and at the end of the 2nd day of study, anxiety was assessed.
Prenatal attachment change
Lasso di tempo: 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.
At baseline and at the end of the 2nd day of study, prenatal attachment was assessed.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Respiratory Rate
Lasso di tempo: 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
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).
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
Lasso di tempo: 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
The heart rate was measured using a digital sphygmomanometer.
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
Lasso di tempo: 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
The systolic blood pressure was measured using a digital sphygmomanometer and recorded in mmHg.
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
Lasso di tempo: 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
The diastolic blood pressure was measured using a digital sphygmomanometer and recorded in mmHg.
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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Nazlı Baltacı, phD, Ondokuz Mayıs University, Assistant Professor phD
  • Direttore dello studio: Mürüvvet Başer, Professor, Erciyes University, Professor

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

6 giugno 2017

Completamento primario (Effettivo)

1 dicembre 2017

Completamento dello studio (Effettivo)

5 dicembre 2018

Date di iscrizione allo studio

Primo inviato

10 agosto 2019

Primo inviato che soddisfa i criteri di controllo qualità

19 agosto 2019

Primo Inserito (Effettivo)

21 agosto 2019

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 novembre 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 novembre 2020

Ultimo verificato

1 novembre 2020

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 363

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Lullaby intervention

Sottoscrivi