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Clinical Trials/NCT05221489
NCT05221489CompletedNot Applicable

The Effects of Listening to Lullabies and Self-selected Music at Home on Prenatal Stress and Anxiety in Nulliparous Pregnant Women: A Randomized-controlled Study

Ondokuz Mayıs University2 sites in 2 countries134 target enrollmentStarted: August 25, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
134
Locations
2
Primary Endpoint
Anxiety change at 2 weeks

Study Overview

Brief Summary

Nulliparous women experience more anxiety and stress during their first transition to motherhood during pregnancy due to inexperience. The aim of this study is to compare the effects of listening to lullabies and the music of their choice at home on reducing the anxiety and stress experienced by nulliparous pregnant women.

This parallel randomized controlled trial was conducted in the obstetrics and gynecology outpatient clinics of a university hospital in eastern Turkey. Lullaby group (LG) recorded only the lullaby chosen by the researcher at home for 30 minutes a day for 2 weeks; mix music group (MG) listened to any of the music recordings presented to them by the researcher. The control group (CG) received general care only. Antenatal stress and anxiety levels were evaluated at the beginning and end of the study.

Detailed Description

Especially, nulliparous women who have experienced their first pregnancy may lose their control while making the first transition to motherhood and incorporating motherhood roles into other areas of their lives due to inexperience, and may be more vulnerable to stress and anxiety. It has been reported that these pregnant women have higher anxiety than those who have given birth. Antenatal anxiety and stress negatively affect maternal and fetal health. Health care professionals can benefit from music interventions to evaluate the anxiety and stress levels of pregnant women, especially in the last trimester, and to improve their physical, emotional and mental health. In some studies, music interventions made at home for pregnant women reduced anxiety and stress, thus providing psychological benefits during pregnancy, childbirth and postpartum period. The aim of this study is to compare the effects of listening to lullabies and the music of their choice at home on reducing the anxiety and stress experienced by nulliparous pregnant women.

This research is a randomized controlled experimental study in parallel group pretest-posttest design. The research was carried out in the obstetrics and gynecology outpatient clinics of a university hospital in eastern Turkey.

The population of the study consisted of healthy pregnant women who applied to the obstetrics clinic of the hospital where the study was conducted for pregnancy follow-up. G ∗ Power 3.1.9 software was used to calculate the sample size of the study. In the power analysis based on state and trait anxiety inventory scores, at least 35 pregnant women were included in each group with 95% confidence interval (1-α), 95.5% test power (1-β), 0.05 error and d=0.887 effect size. needed was determined. The pregnant women (n=16) included in the study were randomly assigned to the lullaby group (NG) (n=40), mixed music group (MG) (n=40) or control group (CG) (n=40) by simple randomization method. The statistician randomized the participants to intervention groups or control groups with the computer program "Quickcalcs graph pad" (http://www.graphpad.com/quickcalcs/, Accessed: 28.07.2021). Participants were grouped according to the randomization list according to the order of admission to the obstetrics clinic.

Necessary information about the study was given to the pregnant women who were suitable and willing to participate in the study. These pregnant women were randomly assigned to one of three groups after taking their written consent. There were two experimental and one control group in the study. One of the experimental group was a lullaby group and the other was a mixed music group. The control group did not listen to music, did not receive any intervention, received routine general care only during hospital visits.

First of all, sociodemographic and obstetric data of the pregnant women were collected, and their anxiety and stress levels were evaluated at the beginning of the study (pretest) and after 2 weeks of music intervention/general care (posttest). These data were collected at the hospital when pregnant women came to their pregnancy follow-ups.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Willing to participate
  • 19 years and older
  • 36th and above gestational week
  • Nulliparous
  • No fetal anomaly
  • Pregnant women who have a WhatsApp application on their phone and can use this application
  • Do not have a psychiatric problem
  • Speaking Turkish

Exclusion Criteria

  • Unwilling to participate
  • Having a risky pregnancy
  • Below the 36th gestational week
  • Multiparous
  • Fetal anomaly
  • Mental, cognitive, psychiatric, hearing and vision problems
  • Illiterate
  • Do not have WhatsApp application on their phone and cannot use this application
  • Do not speak Turkish

Outcomes

Primary Outcomes

Anxiety change at 2 weeks

Time Frame: At baseline and at the end of the 2nd week of study, anxiety was assessed.

As assessed by the State-Trait Anxiety Inventory

Prenatal stress change at 2 weeks

Time Frame: At baseline and at the end of the 2nd week of study, prenatal stress was assessed.

As assessed by the antenatal perceived stress inventory

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Ondokuz Mayıs University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Nazlı Baltacı

Assistant Professor, phD

Ondokuz Mayıs University

Study Sites (2)

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