NCT05228392

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 16, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 8, 2022

Completed
Last Updated

February 8, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

January 12, 2022

Last Update Submit

January 26, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    At baseline and at the end of the 2nd week of study, psychological distress was assessed.

Study Arms (3)

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

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.

Other: listening to music

control group

NO INTERVENTION

The control group (CG) only received routine care. This group do not listened to music.

Interventions

listening to lullaby or other music types

lullaby groupmulti music group

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Using a mobile communication application (e.g., Telegram, WhatsApp)
  • Not having a psychiatric disorder
  • Being able to communicate in Turkish.

You may not qualify if:

  • 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
  • Being illiterate
  • Not using a mobile communication application (e.g., Telegram, WhatsApp)
  • Not being able to communicate in Turkish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun Training and Research Hospital, Obstetrics and Gynecology Clinic, Gynecology and Obstetrics Polyclinics

Samsun, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

Study Officials

  • Nazlı Baltacı, phD

    Ondokuz Mayıs University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, phD

Study Record Dates

First Submitted

January 12, 2022

First Posted

February 8, 2022

Study Start

June 16, 2021

Primary Completion

October 15, 2021

Study Completion

October 15, 2021

Last Updated

February 8, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations