Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05195307
Recruitment Status : Completed
First Posted : January 18, 2022
Last Update Posted : January 18, 2022
Sponsor:
Information provided by (Responsible Party):
Ebru Ertas, Kutahya Health Sciences University

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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.



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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05195307


Locations
Layout table for location information
Turkey
Kutahya Health Sciences University
Kütahya, Turkey, 43100
Sponsors and Collaborators
Kutahya Health Sciences University
Investigators
Layout table for investigator information
Principal Investigator: Ebru Ertaş, Master Kutahya Health Sciences University
Study Director: Neşe Çelik, Phd Eskisehir Osmangazi University
Layout table for additonal 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    Key Record Dates
Last Update Posted: January 18, 2022
Last Verified: January 2022

Layout table for additional information
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:
Layout table for MeSH terms
Anxiety Disorders
Mental Disorders