The Effect of Lullaby Intervention on Anxiety and Attachment in Pregnancy

NCT04064320 | Completed

• 1 other identifier: 363
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Anxiety; Attachment Disorder; Pregnancy Related

Keywords

pregnancy; high-risk; anxiety; prenatal attachment; bonding; lullaby; music

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  At baseline and at the end of the 2nd day of study, prenatal attachment was assessed.

Secondary Outcomes (4)

• Change in Respiratory Rate

  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

  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

  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

  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

Study Arms (2)

Intervention group

EXPERIMENTAL

Received lullaby intervention and usual care

Behavioral: Lullaby intervention

Control group

NO INTERVENTION

No intervention other than usual care

Interventions

Lullaby intervention BEHAVIORAL

Listening to lullabies, and accompanied by lullabies touching their abdomen and think about their babies of hospitalized women with high-risk pregnancy

Intervention group

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalization due to high-risk pregnancy
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayıs University, Faculty of Health Sciences

Samsun, 55200, Turkey (Türkiye)

Location

Related Publications (24)

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MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Nazlı Baltacı, phD

  Ondokuz Mayıs University, Assistant Professor phD

  PRINCIPAL INVESTIGATOR

• Mürüvvet Başer, Professor

  Erciyes University, Professor

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 10, 2019
• First Posted: August 21, 2019
• Study Start: June 6, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 5, 2018
• Last Updated: November 6, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)