Music TherapyNCT05195307
The Effect of Music Therapy Applied to Pregnant Women on Anxiety and Stress
A study testing Music Group in people with Music Therapy, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Music Therapy
- What is being tested?
- Music Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2019to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant women who did not meet the inclusion criteria and pregnant women who did not listen to music regularly were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University
Kütahya, 43100
About this study
Official title: Effectiveness of Music Therapy on Anxiety and Stress Levels of Primiparous Pregnants in the Third Trimester: A Randomised Controlled Trial
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.
Read the 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.
- Conditions
- Music Therapy
- Being tested
- Music Group
- Keywords
- midwifery, pregnancy, music, anxiety, stress
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Music Group | Experimental | 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. Receives: Other: Music Group |
| Control Group | No intervention | In the study, pregnant women in the control group were trained by the researcher on preparing for normal delivery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start1 Nov 2019
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Music TherapyStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized study with an application and a control group.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Ertas, Kutahya Health Sciences University
- Investigators
- Ebru Ertaş, Master, Principal investigator, Kutahya Health Sciences UniversityNeşe Çelik, Phd, Study director, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05195307
- Sponsor's protocol ID
- Ayşe Koçak Sezgin
- Status last verified
- Jan 2022
- First submitted
- 15 Dec 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Music Therapy on Anxiety and Stress Levels of Primiparous Pregnants in the Third Trimester: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05195307
- Acronym / sponsor ID
- Ayşe Koçak Sezgin
- Conditions
- Music Therapy
- Keywords
- midwifery, pregnancy, music, anxiety, stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized study with an application and a control group.
| Arm | Type | Receives |
|---|---|---|
| Music Group | Experimental | Other: Music GroupApplication 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. |
| Control Group | No intervention | –In the study, pregnant women in the control group were trained by the researcher on preparing for normal delivery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (1 listed)
- Pregnant women who did not meet the inclusion criteria and pregnant women who did not listen to music regularly were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music GroupPregnant 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. | Other | Music Group |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebru Ertaş, Master principal investigator
Kutahya Health Sciences University
Neşe Çelik, Phd study director
Eskisehir Osmangazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Group in people with Music Therapy, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.