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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05195307
Other study ID # Ayse Koçak Sezgin
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2019
Est. completion date August 31, 2020

Study information

Verified date January 2022
Source Kutahya Health Sciences University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Anxiety and stress increase in primiparous pregnant women and especially in the third trimester of pregnancy. This study was conducted to investigate the effect of music therapy applied to pregnant women who will give birth for the first time and are in the last trimester of their pregnancy on anxiety and stress. The study is a randomized controlled trial. Pregnant women in the application group were regularly listened to music for 20 minutes a day for 10 days. In the study, pregnant women in the application and control group were trained by the researcher on preparing for normal delivery. The pregnant women who participated in the study completed the Personal Information Form, the State and Trait Anxiety Inventory and the Pregnancy Stress Rating Scale at the beginning. 10, the last day of study. on the day, the scales are repeated.


Description:

Aims and objectives: This study aimed to evaluate the effect of music therapy on the anxiety and stress levels of primiparous pregnants in the third trimester. Background: Anxiety and stress during pregnancy, when not well-managed, can lead to negative birth outcomes. Design: This study is a randomized controlled trial. Methods: This study was conducted in Turkey with 120 pregnant, 60 of whom were in the music group and 60 in the control group. Research data were collected with Personal Information Form, State-Trait Anxiety Inventory and Pregnancy Stress Rating Scale-36. Pregnants were made to listen to music for 20 minutes every day for ten days. The anxiety and stress levels of pregnant were measured before and after the intervention.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date August 31, 2020
Est. primary completion date August 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Pregnant women aged 18 and over, - Primiparous pregnants, - In the third trimester (28 and above gestational week), - Speaking and writing in Turkish, - Having no vision-hearing problems, - Having and using internet-supported online Web 2.0 tools, - Volunteering to participate in the study were included in the study within the scope of inclusion criteria. Exclusion Criteria: - Pregnant women who did not meet the inclusion criteria and pregnant women who did not listen to music regularly were excluded from the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Music Group
Pregnant women included in the practice group were given 20 minutes of music every day for ten days. Anxiety and stress levels of pregnant women were measured before and after the intervention.

Locations

Country Name City State
Turkey Kutahya Health Sciences University Kütahya

Sponsors (1)

Lead Sponsor Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The effect of ten-day music therapy on anxiety levels of pregnant women Pre-intervention, a personal information form and a State and Trait Anxiety Inventory (STAI I-II) (Oner and Le Compte, 1998) were used to assess the anxiety levels of pregnant women. The minimum score they will receive from the State and Trait Anxiety Inventory is 0, the maximum score is 80. The music therapy application lasted for 10 days. Through study completion the final test of the a State and Trait Anxiety Inventory (STAI I-II) was performed with pregnant women.
Primary The effect of ten-day music therapy on stress levels of pregnant women Pre-intervention, a Pregnancy Stress Rating Scale (Akin and Erbil, 2018) (PSRS) were used to assess the stress levels of pregnant women. The minimum score they will receive from the Pregnancy Stress Rating Scale is 0, the maximum is 144. The music therapy application lasted for 10 days. Through study completion final test of the a Pregnancy Stress Rating Scale (PSRS) was performed with pregnant women.
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