The Effects of Listening to Lullabies and Self-selected Music on Prenatal Stress and Anxiety in Pregnant Women
Primary Purpose
Anxiety, Stress-Related, in Pregnancy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
listening to lullabies or self-selected music
Sponsored by
About this trial
This is an interventional supportive care trial for Anxiety, Stress-Related, in Pregnancy
Eligibility Criteria
Inclusion Criteria:
- Willing to participate
- Healthy
- 19 years and older
- 36th and above gestational week
- Nulliparous
- No fetal anomaly
- Literate
- 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
Sites / Locations
- Fırat University, Gynecology and Obstetrics Polyclinics
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
lullaby group
mix music group
control group
Arm Description
For two weeks and 30 minutes every day at home, the lullaby group (LG) only listened to the lullaby record selected by the researcher.
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.
The control group (CG) only received routine care.
Outcomes
Primary Outcome Measures
Anxiety change at 2 weeks
As assessed by the State-Trait Anxiety Inventory
Prenatal stress change at 2 weeks
As assessed by the antenatal perceived stress inventory
Secondary Outcome Measures
Full Information
NCT ID
NCT05221489
First Posted
January 13, 2022
Last Updated
January 21, 2022
Sponsor
Ondokuz Mayıs University
Collaborators
Firat University
1. Study Identification
Unique Protocol Identification Number
NCT05221489
Brief Title
The Effects of Listening to Lullabies and Self-selected Music on Prenatal Stress and Anxiety in Pregnant Women
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 25, 2021 (Actual)
Primary Completion Date
December 15, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ondokuz Mayıs University
Collaborators
Firat University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Music initiatives (lullaby group and mixed music group):
The pregnant women in the lullaby group were told to listen only to the lullaby recording chosen by the researcher for 30 minutes a day for 2 weeks at home. Various music recordings consisting of "nature sounds, classical western music, Turkish music and lullaby" recordings prepared by the researchers were sent to the Mixed music group, and they were told to choose and listen to any of these recordings for 30 minutes a day for 2 weeks. Consultancy was received from a lecturer in the Musicology department regarding these music recordings. The music recordings were sent to the pregnant women through the mobile communication application (telegram, whatsapp, etc.) so that they could listen to them on their own phones, and they were asked to download/save the music recordings on their phones.
All pregnant women who were going to have a music attempt were informed about the way and conditions of listening to music at home. Based on previous studies, a guide to listening to music at home during pregnancy was developed. Accordingly, lullabies and other musical genres mentioned were used, with a slow rhythm (ranging between 60-70 beats per minute when measured with a metronome) and soft melody compatible with the normal heart rate. It was reported that pregnant women should use their own headphones in a quiet and poorly lit room to avoid being affected by ambient sounds while listening to music, they should prefer and adjust the volume of the music before listening, empty their bladder and not be hungry. The situation of performing these music attempts at home was followed up by the researcher by talking to the pregnant women on the phone every day. Researchers and participants were not blinded to the study due to the nature of the music enterprise. During the study, the routine care and follow-up of the pregnant women was not interfered with.
The data on the sociodemographic and obstetric characteristics of the pregnant women were collected with the personal information form created by the researchers in line with the literature. Anxiety and antenatal stress, which are the primary results of the study, were evaluated with the "State-Trait Anxiety Inventory" and the "Perceived Prenatal Stress Scale".
Data were evaluated using the IBM SPSS v.23 (IBM Corp. Armonk, NY, USA) program. Data were presented with descriptive statistics such as number, percentage, arithmetic mean, standard deviation. Chi-square test was used for categorical variables, and One way variance analysis (ANOVA) for the continuous variables to confirm differences in sociodemographic and obstetrics characteristics between the groups. The scores of the STAI and APSI between groups were compared using One way variance analysis (ANOVA) and Tukey test, for comparison within groups was used Paired samples t-test. Statistical significance value was accepted as p<0.05.
This study has some limitations and difficulties. The first of these; Since it is a single-center study, its results cannot be generalized to all healthy pregnant women. Latter; The long-term effectiveness of lullabies or other music concerts cannot be evaluated, since no follow-up was made during the pregnancy and postpartum period after the music attempt in the study. Third; The fact that pregnant women are asked to listen to music at home and that it is followed by phone makes it difficult to fully implement the intervention in terms of duration and conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Stress-Related, in Pregnancy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lullaby group
Arm Type
Experimental
Arm Description
For two weeks and 30 minutes every day at home, the lullaby group (LG) only listened to the lullaby record selected by the researcher.
Arm Title
mix music group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
No Intervention
Arm Description
The control group (CG) only received routine care.
Intervention Type
Other
Intervention Name(s)
listening to lullabies or self-selected music
Intervention Description
listening to lullabies for lullaby group and listening to music of their choice among various music for mix music group
Primary Outcome Measure Information:
Title
Anxiety change at 2 weeks
Description
As assessed by the State-Trait Anxiety Inventory
Time Frame
At baseline and at the end of the 2nd week of study, anxiety was assessed.
Title
Prenatal stress change at 2 weeks
Description
As assessed by the antenatal perceived stress inventory
Time Frame
At baseline and at the end of the 2nd week of study, prenatal stress was assessed.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Willing to participate
Healthy
19 years and older
36th and above gestational week
Nulliparous
No fetal anomaly
Literate
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
Facility Information:
Facility Name
Fırat University, Gynecology and Obstetrics Polyclinics
City
Elazığ
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data that support the findings of this study are available from the corresponding author (N.B. or Ö.D.Y.) upon reasonable request.
Learn more about this trial
The Effects of Listening to Lullabies and Self-selected Music on Prenatal Stress and Anxiety in Pregnant Women
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