The Effect of Music Therapy Applied to Pregnant Women on Anxiety and Stress

• ClinicalTrials.gov Identifier: NCT05195307
• Recruitment Status: Completed
• First Posted: January 18, 2022
• Last Update Posted: January 18, 2022
• Sponsor: Kutahya Health Sciences University
• Information provided by (Responsible Party): Ebru Ertas, Kutahya Health Sciences University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Music Therapy	Other: Music Group	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A randomized study with an application and a control group.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Effectiveness of Music Therapy on Anxiety and Stress Levels of Primiparous Pregnants in the Third Trimester: A Randomised Controlled Trial
• Actual Study Start Date: November 1, 2019
• Actual Primary Completion Date: August 31, 2020
• Actual Study Completion Date: August 31, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Music Group; Application Group Pregnant women in the application group were regularly listened to music for 20 minutes a day for 10 days. In addition, the pregnant women in the application group were trained by the researcher on preparing for normal delivery.	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.
No Intervention: Control Group; In the study, pregnant women in the control group were trained by the researcher on preparing for normal delivery.

Outcome Measures

Primary Outcome Measures :

1. The effect of ten-day music therapy on anxiety levels of pregnant women [ Time Frame: 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. ]
   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.
2. The effect of ten-day music therapy on stress levels of pregnant women [ Time Frame: 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. ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Turkey

Kutahya Health Sciences University

Kütahya, Turkey, 43100

Sponsors and Collaborators

Kutahya Health Sciences University

Investigators

• Principal Investigator: Ebru Ertaş, Master; Kutahya Health Sciences University
• Study Director: Neşe Çelik, Phd; Eskisehir Osmangazi University

More Information

• Responsible Party: Ebru Ertas, Research Assistant, Kutahya Health Sciences University
• ClinicalTrials.gov Identifier: NCT05195307
• Other Study ID Numbers: Ayşe Koçak Sezgin
• First Posted: January 18, 2022
• Last Update Posted: January 18, 2022
• Last Verified: January 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ebru Ertas, Kutahya Health Sciences University:

midwifery; pregnancy; music; anxiety; stress

Additional relevant MeSH terms:

Anxiety Disorders; Mental Disorders