Clinical trial NCT05195307: The Effect of Music Therapy Applied to Pregnant Women on Anxiety and Stress
Official title: Effectiveness of Music Therapy on Anxiety and Stress Levels of Primiparous Pregnants in the Third Trimester: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Music Therapy
Keywords: midwifery
pregnancy
music
anxiety
stress
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized study with an application and a control group.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The effect of ten-day music therapy on anxiety levels of pregnant women
timeFrame: 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.
measure: The effect of ten-day music therapy on stress levels of pregnant women
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kutahya Health Sciences University
Study officials:
affiliation: Kutahya Health Sciences University
name: Ebru Ertaş, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Eskisehir Osmangazi University
name: Neşe Çelik, Phd
role: STUDY_DIRECTOR
References: