MusicNCT06137872
The Effect of Music on Nonstress Test and Pregnant Women's Satisfaction
A study testing Music Group in people with Music, run by Resmiye KAYA ODABAŞ at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted as a randomized controlled trial. This study was conducted to determine the effect of music on nonstress test and pregnant woman's satisfaction. The study was conducted with pregnant women who applied for non-stress testing at a hospital in Samsun, Turkey, between September 2021 and September… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Music
- What is being tested?
- Music Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Sep 2021to Dec 2023
- 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Criteria for Inclusion of Volunteers in the Research:
- Are between the ages of 18-35,
- Pregnancy week 32 and above,
- Having a singleton and live pregnancy,
- Have had non-stress test at least once before,
- Able to speak and understand Turkish,
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- Pregnant women who were at least primary school graduates were included in the study.
- Conditions to be met before Nonstress Testing
- Eating at least two hours before the non-stress test,
- Do not smoke, drink alcohol or use drugs for at least two hours before the non-stress test,
- Do not engage in vigorous activity for at least two hours before the non-stress test,
- Nonstress urinates just before the test,
- Basal heart rate is 110-160 beats per minute
Who cannot join
- Criteria for Excluding Preganat in the Research
- Having uterine contraction as a result of nonstress test,
- In any situation that develops acutely during the non-stress test,
- Those who cannot complete non-stress test for any reason,
- Psychologically diagnosed (such as depression, schizophrenia)
- Having any chronic disease (such as diabetes, hypertension, heart failure)
Show all 10Show fewer
- Having pregnancy complications (such as preeclampsia, gestational diabetes, Rh incompatibility)
- Having a history of infertility and becoming pregnant with assisted reproductive techniques,
- Having a problem identified in the fetus (anomaly, intrauterine growth retardation and cardiovascular disease),
- Pregnant women who provided incorrect or incomplete information were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Music on Nonstress Test and Pregnant Women's Satisfaction: Randomized Controlled Study
This study was conducted as a randomized controlled trial. This study was conducted to determine the effect of music on nonstress test and pregnant woman's satisfaction. The study was conducted with pregnant women who applied for non-stress testing at a hospital in Samsun, Turkey, between September 2021 and September 2022. Pregnant women who met the research criteria were divided into two groups: physical and control groups. The research was completed experimentally with a total of 111 pregnant women, 56 experimental and 55 control. The researcher had a face-to-face interview with all the pregnant women and filled out the "Pregnant Introduction Form". Then, the vital signs of the pregnant women were taken and the pregnant women were placed in the left side-lying position. Fundus height, situs and position were determined using Leopold maneuvers. During the non-stress test shooting, the music group was allowed to listen to music for at least 20 minutes during the NST period. No intervention was made to the control group. After the non-stress test is completed, the "Satisfaction Evaluation Scale" is taken by the pregnant woman herself. The "Nonstress Test Monitoring Form" was filled out by the researcher through notification. The data of the study were evaluated using the Statistical Package for the Social Sciences program. All data were first analyzed by Kolmogorov-Smirnov for conformity with normal distribution. were evaluated and then analyzed according to their suitability for normal distribution. For descriptive statistics, percentage across the board, arithmetic mean±standard deviation for those with normal distribution, median and minimum-maximum values for those that did not fit were used. In the analysis of the data, student t test and ANOVA test were used for those that were suitable for normal distribution, and Mann-Whitney U and Kruskal Wallis tests were used for those that were not suitable for normal distribution. Type 1 error level was taken as 0.05.
Read the detailed description
Aim: To determine the effect of music on non-stress test and pregnant woman's satisfaction.
Hypotheses:
H01: There is a difference between the non-stress test results of pregnant women who received music and the control group pregnant women.
H02: There is no difference between the satisfaction levels of pregnant women who received music and the control group pregnant women.
Method: The research was conducted in the non-stress test room in the gynecology outpatient clinic of a hospital in Samsun. The population of the research consisted of pregnant women who applied to the non-stress test room for non-stress test examination after having a pregnancy follow-up at the gynecology outpatient clinic of this hospital.
Sample Size: The sample number of the study was calculated according to the power analysis performed with the G Power 3.1.9.2 program. Accordingly, for the use of t-test in independent groups, effect size: 0.5, alpha = 0.05 and power: 0.80 were calculated and a total of at least 51 pregnant women were included in each group. 102 pregnant women were calculated. In order to increase the analysis power of the research, the sample size was completed with 111 pregnant women (music group: 56, control group: 55). The pregnant women in the music group and the control group were stratified according to age and the groups were distributed homogeneously.
provided. Which group the participants would be in was determined by full randomization technique on the website www.randomizer.org.
Data Collection Tools The data of the study were collected with the Pregnant Introduction Form, non-stress Monitoring Form and Satisfaction Evaluation Scale created by the researcher.
Pregnant Introduction Form: This form was developed by the researcher. It consists of questions including socio-demographic and obstetric characteristics and vital signs of pregnant women.
Nonstress Test Monitoring Form: This form was developed by the researcher and is the form preferred by pregnant women during non-stress examination.
It consists of questions about the music genre, thoughts about non-stress, and findings about non-stress for the researcher to evaluate the non-stress result. It consists of a total of 15 questions that determine pregnant women's thoughts about non-stress and include findings regarding non-stress. Non-stress results of the pregnant women were evaluated by the researcher. If there was any doubt in the evaluation, it was re-evaluated with the gynecologist.
Reactive non-stress; It was defined as the presence of at least two fetal movements within a 20-minute period, parallel to the movements, accelerations in the fetal heart rate that were more than 15 beats above the basal heart rate and lasted more than 15 seconds.
Nonreactive non-stress; It was defined as the absence of fetal movements or the presence of fetal movements, but accelerations of less than 15 beats and lasting less than 15 seconds within a 20-minute period.
Satisfaction Evaluation Scale: This scale was adapted by researchers similar to the "Visual Analog Scale (VAS)" usage principles. One end of VAS is "very good" and the other end is "very bad".
It is a scale that is evaluated by individuals by making markings on a horizontal or vertical line of 10 cm or 100 mm. This line may be just a straight line, or it may be divided at equal intervals or have descriptive words placed on the line. VAS is used to make some values that cannot be measured numerically measurable. In this scale, in order to evaluate whether the pregnant women in the music group were satisfied with the music during the non-stress shooting, the numbers between 0 and 10 were placed on a vertical line, where they would indicate with a cross (X) the point corresponding to their satisfaction with the procedure as a result of the application. In the scale, 0 points indicate "I was not satisfied at all" with the application result, and 10 points indicate "I was very satisfied" with the application result.
Collection of Data After obtaining the necessary ethics committee and institutional permission to conduct the study, the institution was visited and the pregnant women who came for non-stress examination were met. Pregnant women who meet the research criteria during working hours An explanation will be made about the purpose of the research, its content and the methods to be applied, and those who want to participate in the study are determined. Then, a random number generation program determines which group the pregnant women will be in.
They were divided into two groups: music and control groups using the "Research Randomizer". Thus, each pregnant woman's number and group number were determined and recorded. Oral and written consent of those who accepted the research Their consent was taken. The researcher had a face-to-face interview with all the pregnant women and filled out the "Pregnant Introduction Form". Then, the vital signs of the pregnant women will be taken and the pregnant women will be placed in the left side-lying position.
Fundus height, situs and position were determined using Leopold maneuvers. During the NST shooting, the music group was allowed to listen to music for at least 20 minutes during the non-stress. In the control group, no intervention was given.
It will not be done. After the nonstress test was completed, the "Satisfaction Evaluation Scale" was filled out by the pregnant woman through self-report, and the "Nonstress Test Follow-up Form" was filled out by the researcher. The interview number specified in the survey form will be written in the upper right corner of the Nonstress Test paper, and a copy of the nonstress test paper was taken with the Adobe Scan scanner installed on the smartphone device.
Statistical analysis The data of the study were evaluated using the Statistical Package for the Social Sciences (SPSS) program. All data were first evaluated with Kolmogorov-Smirnov for suitability for normal distribution, and then analyzed according to their suitability for normal distribution. For descriptive statistics, percentage across the board, arithmetic mean±standard deviation for those with normal distribution, median and minimum-maximum values for those that did not fit were used. In the analysis of the data, student t test and ANOVA test were used for those suitable for normal distribution, Mann-Whitney U and Kruskal test for those not suitable for normal distribution.
Wallis test was used. Type 1 error level was taken as 0.05.
- Conditions
- Music
- Being tested
- Music Group, Control Group
- Keywords
- music, non-stress test, pregnant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music GroupOther
Pregnant women who came to the hospital for non-stress testing were met and informed about the study. The procedure was applied for non-stress testing. In the music group, the pregnant woman, who was assigned to the next group according to randomization during the non-stress test, was allowed to listen to music with disposable headphones for at least 20 minutes until the procedure was completed. At the same time, the mother will be asked to close her eyes and be relaxed. Headphones used to prevent infection were given to the pregnant woman as a gift at the end of the procedure.
Control GroupOther
Pregnant women who came to the hospital for non-stress testing were met and informed about the study. The procedure was applied for non-stress testing. During the non-stress test, routine non-stress test was performed on the pregnant control group, which was assigned to the next group according to randomization.
| Study group | Role | What they receive |
|---|---|---|
| Music Group | Experimental | During the non-stress test shooting, the music group was allowed to listen to music via headphones once for at least 20 minutes. Receives: Other: Music Group |
| Control Group | Experimental | No application was made and non-stress test shooting was performed. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal heart rate
After the non-stress test was taken, the basal fetal heart rate on the non-stress test paper was calculated.
Measured: Immediately after non-stress test
Variability
After the non-stress test was taken, the variability rate on the non-stress test paper was calculated.
- Increased variability (change greater than 25 beats/min from basal heart rate)
- Moderate variability (6-25 beats/min change from basal heart rate)
- Decreased variability (3-5 beats/min change from basal heart rate)
- No variability (0-2 beats/min change from basal heart rate)
Measured: Immediately after non-stress test
Presence of fetal movement
After the non-stress test was taken, the presence of fetal movement on the non-stress test paper was calculated.After the non-stress test, the presence of fetal movement will be evaluated as presence/absence on the evaluation sheet, and if there is fetal movement, the number is determined.
Measured: Immediately after non-stress test
Presence of acceleration
After taking the non-stress test, the presence of acceleration was calculated on the non-stress test paper. After the non-stress test, the presence of acceleration was evaluated as present/absent on the evaluation sheet and, if present, the number was determined.
Measured: Immediately after non-stress test
Time to first acceleration
As a result of the non-stress test, the time until the first acceleration was calculated.
Measured: Immediately after non-stress test
Presence of deceleration
After taking the non-stress test, the presence of deceleration was calculated on the non-stress test paper. After the non-stress test, the presence of deceleration was evaluated as present/absent on the evaluation sheet and, if present, the number was determined.
Measured: Immediately after non-stress test
The type of deceleration
According to the non-stress test results,
- Early deceleration
- Late deceleration
- Variable deceleration evaluation was performed.
Measured: Immediately after non-stress test
Nonstress test result
Evaluations are made according to the nonstress test results
- Reactive (negative) non-stress test (here should be at least two fetal movements within a 20-minute period, and in parallel with the movements, the fetal heart Accelerations in which the heart rate is more than 15 beats above the basal heart rate and last more than 15 seconds It will be said to be)
- Nonreactive (positive) non-stress test (Absence of fetal movements or presence of fetal movements within 20 minutes It will be defined as the presence of accelerations that are less than a beat and last less than 15 seconds)
- Questionable non-stress test evaluation was performed.
Measured: Immediately after non-stress test
Satisfaction Evaluation Scale
This scale was adapted by researchers similar to the "Visual Analog Scale " usage principles. Visual Analog Scale is a scale evaluated by individuals by making marks on a horizontal or vertical line of 10 cm or 100 mm, one end of which indicates that the individual is "very good" and the other end indicates that the individual is "very bad". This line can be just a straight line or evenly spaced.
Measured: Immediately after non-stress test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start2 Sep 2021
- Primary completion12 Sep 2022
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MusicStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Resmiye KAYA ODABAŞ
- Sponsor type
- University, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Responsible party
- Sponsor-investigator, Resmiye KAYA ODABAŞ, Kocaeli University
- Investigators
- Yasemin Sökmen, Dr, Principal investigator, Ondokuz Mayıs UniversityResmiye Kaya Odabaş, Dr, Study chair, Kocaeli UniversityBahadır Yazıcıoğlu, Dr, Study chair, Samsun Provincial Health Directorate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137872
- Sponsor's protocol ID
- KoceliU
- Status last verified
- Nov 2023
- First submitted
- 10 Nov 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music on Nonstress Test and Pregnant Women's Satisfaction: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06137872
- Acronym / sponsor ID
- KoceliU
- Conditions
- Music
- Keywords
- music, non-stress test, pregnant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Resmiye KAYA ODABAŞUniversity, hospital or other
- Collaborators
- Ondokuz Mayıs University
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 12 Sep 2022 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 Nov 2023 (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.
This study was conducted as a randomized controlled trial. This study was conducted to determine the effect of music on nonstress test and pregnant woman's satisfaction. The study was conducted with pregnant women who applied for non-stress testing at a hospital in Samsun, Turkey, between September 2021 and September 2022. Pregnant women who met the research criteria were divided into two groups: physical and control groups. The research was completed experimentally with a total of 111 pregnant women, 56 experimental and 55 control. The researcher had a face-to-face interview with all the pregnant women and filled out the "Pregnant Introduction Form". Then, the vital signs of the pregnant women were taken and the pregnant women were placed in the left side-lying position. Fundus height, situs and position were determined using Leopold maneuvers. During the non-stress test shooting, the music group was allowed to listen to music for at least 20 minutes during the NST period. No intervention was made to the control group. After the non-stress test is completed, the "Satisfaction Evaluation Scale" is taken by the pregnant woman herself. The "Nonstress Test Monitoring Form" was filled out by the researcher through notification. The data of the study were evaluated using the Statistical Package for the Social Sciences program. All data were first analyzed by Kolmogorov-Smirnov for conformity with normal distribution. were evaluated and then analyzed according to their suitability for normal distribution. For descriptive statistics, percentage across the board, arithmetic mean±standard deviation for those with normal distribution, median and minimum-maximum values for those that did not fit were used. In the analysis of the data, student t test and ANOVA test were used for those that were suitable for normal distribution, and Mann-Whitney U and Kruskal Wallis tests were used for those that were not suitable for normal distribution. Type 1 error level was taken as 0.05.
Detailed description
Aim: To determine the effect of music on non-stress test and pregnant woman's satisfaction.
Hypotheses:
H01: There is a difference between the non-stress test results of pregnant women who received music and the control group pregnant women.
H02: There is no difference between the satisfaction levels of pregnant women who received music and the control group pregnant women.
Method: The research was conducted in the non-stress test room in the gynecology outpatient clinic of a hospital in Samsun. The population of the research consisted of pregnant women who applied to the non-stress test room for non-stress test examination after having a pregnancy follow-up at the gynecology outpatient clinic of this hospital.
Sample Size: The sample number of the study was calculated according to the power analysis performed with the G Power 3.1.9.2 program. Accordingly, for the use of t-test in independent groups, effect size: 0.5, alpha = 0.05 and power: 0.80 were calculated and a total of at least 51 pregnant women were included in each group. 102 pregnant women were calculated. In order to increase the analysis power of the research, the sample size was completed with 111 pregnant women (music group: 56, control group: 55). The pregnant women in the music group and the control group were stratified according to age and the groups were distributed homogeneously.
provided. Which group the participants would be in was determined by full randomization technique on the website www.randomizer.org.
Data Collection Tools The data of the study were collected with the Pregnant Introduction Form, non-stress Monitoring Form and Satisfaction Evaluation Scale created by the researcher.
Pregnant Introduction Form: This form was developed by the researcher. It consists of questions including socio-demographic and obstetric characteristics and vital signs of pregnant women.
Nonstress Test Monitoring Form: This form was developed by the researcher and is the form preferred by pregnant women during non-stress examination.
It consists of questions about the music genre, thoughts about non-stress, and findings about non-stress for the researcher to evaluate the non-stress result. It consists of a total of 15 questions that determine pregnant women's thoughts about non-stress and include findings regarding non-stress. Non-stress results of the pregnant women were evaluated by the researcher. If there was any doubt in the evaluation, it was re-evaluated with the gynecologist.
Reactive non-stress; It was defined as the presence of at least two fetal movements within a 20-minute period, parallel to the movements, accelerations in the fetal heart rate that were more than 15 beats above the basal heart rate and lasted more than 15 seconds.
Nonreactive non-stress; It was defined as the absence of fetal movements or the presence of fetal movements, but accelerations of less than 15 beats and lasting less than 15 seconds within a 20-minute period.
Satisfaction Evaluation Scale: This scale was adapted by researchers similar to the "Visual Analog Scale (VAS)" usage principles. One end of VAS is "very good" and the other end is "very bad".
It is a scale that is evaluated by individuals by making markings on a horizontal or vertical line of 10 cm or 100 mm. This line may be just a straight line, or it may be divided at equal intervals or have descriptive words placed on the line. VAS is used to make some values that cannot be measured numerically measurable. In this scale, in order to evaluate whether the pregnant women in the music group were satisfied with the music during the non-stress shooting, the numbers between 0 and 10 were placed on a vertical line, where they would indicate with a cross (X) the point corresponding to their satisfaction with the procedure as a result of the application. In the scale, 0 points indicate "I was not satisfied at all" with the application result, and 10 points indicate "I was very satisfied" with the application result.
Collection of Data After obtaining the necessary ethics committee and institutional permission to conduct the study, the institution was visited and the pregnant women who came for non-stress examination were met. Pregnant women who meet the research criteria during working hours An explanation will be made about the purpose of the research, its content and the methods to be applied, and those who want to participate in the study are determined. Then, a random number generation program determines which group the pregnant women will be in.
They were divided into two groups: music and control groups using the "Research Randomizer". Thus, each pregnant woman's number and group number were determined and recorded. Oral and written consent of those who accepted the research Their consent was taken. The researcher had a face-to-face interview with all the pregnant women and filled out the "Pregnant Introduction Form". Then, the vital signs of the pregnant women will be taken and the pregnant women will be placed in the left side-lying position.
Fundus height, situs and position were determined using Leopold maneuvers. During the NST shooting, the music group was allowed to listen to music for at least 20 minutes during the non-stress. In the control group, no intervention was given.
It will not be done. After the nonstress test was completed, the "Satisfaction Evaluation Scale" was filled out by the pregnant woman through self-report, and the "Nonstress Test Follow-up Form" was filled out by the researcher. The interview number specified in the survey form will be written in the upper right corner of the Nonstress Test paper, and a copy of the nonstress test paper was taken with the Adobe Scan scanner installed on the smartphone device.
Statistical analysis The data of the study were evaluated using the Statistical Package for the Social Sciences (SPSS) program. All data were first evaluated with Kolmogorov-Smirnov for suitability for normal distribution, and then analyzed according to their suitability for normal distribution. For descriptive statistics, percentage across the board, arithmetic mean±standard deviation for those with normal distribution, median and minimum-maximum values for those that did not fit were used. In the analysis of the data, student t test and ANOVA test were used for those suitable for normal distribution, Mann-Whitney U and Kruskal test for those not suitable for normal distribution.
Wallis test was used. Type 1 error level was taken as 0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Group | Experimental | Other: Music GroupDuring the non-stress test shooting, the music group was allowed to listen to music via headphones once for at least 20 minutes. |
| Control Group | Experimental | Other: Control GroupNo application was made and non-stress test shooting was performed. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Criteria for Inclusion of Volunteers in the Research:
- Are between the ages of 18-35,
- Pregnancy week 32 and above,
- Having a singleton and live pregnancy,
- Have had non-stress test at least once before,
Key exclusion criteria (10 listed)
- Criteria for Excluding Preganat in the Research
- Having uterine contraction as a result of nonstress test,
- In any situation that develops acutely during the non-stress test,
- Those who cannot complete non-stress test for any reason,
- Psychologically diagnosed (such as depression, schizophrenia)
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 who came to the hospital for non-stress testing were met and informed about the study. The procedure was applied for non-stress testing. In the music group, the pregnant woman, who was assigned to the next group according to randomization during the non-stress test, was allowed to listen to music with disposable headphones for at least 20 minutes until the procedure was completed. At the same time, the mother will be asked to close her eyes and be relaxed. Headphones used to prevent infection were given to the pregnant woman as a gift at the end of the procedure. | Other | Music Group |
| Control GroupPregnant women who came to the hospital for non-stress testing were met and informed about the study. The procedure was applied for non-stress testing. During the non-stress test, routine non-stress test was performed on the pregnant control group, which was assigned to the next group according to randomization. | Other | Control Group |
Primary outcome
Fetal heart rate
Time frame: Immediately after non-stress test
After the non-stress test was taken, the basal fetal heart rate on the non-stress test paper was calculated.
Variability
Time frame: Immediately after non-stress test
After the non-stress test was taken, the variability rate on the non-stress test paper was calculated. 1. Increased variability (change greater than 25 beats/min from basal heart rate) 2. Moderate variability (6-25 beats/min change from basal heart rate) 3. Decreased variability (3-5 beats/min change from basal heart rate) 4. No variability (0-2 beats/min change from basal heart rate)
Presence of fetal movement
Time frame: Immediately after non-stress test
After the non-stress test was taken, the presence of fetal movement on the non-stress test paper was calculated.After the non-stress test, the presence of fetal movement will be evaluated as presence/absence on the evaluation sheet, and if there is fetal movement, the number is determined.
Presence of acceleration
Time frame: Immediately after non-stress test
After taking the non-stress test, the presence of acceleration was calculated on the non-stress test paper. After the non-stress test, the presence of acceleration was evaluated as present/absent on the evaluation sheet and, if present, the number was determined.
Time to first acceleration
Time frame: Immediately after non-stress test
As a result of the non-stress test, the time until the first acceleration was calculated.
Presence of deceleration
Time frame: Immediately after non-stress test
After taking the non-stress test, the presence of deceleration was calculated on the non-stress test paper. After the non-stress test, the presence of deceleration was evaluated as present/absent on the evaluation sheet and, if present, the number was determined.
The type of deceleration
Time frame: Immediately after non-stress test
According to the non-stress test results, 1. Early deceleration 2. Late deceleration 3. Variable deceleration evaluation was performed.
Nonstress test result
Time frame: Immediately after non-stress test
Evaluations are made according to the nonstress test results 1. Reactive (negative) non-stress test (here should be at least two fetal movements within a 20-minute period, and in parallel with the movements, the fetal heart Accelerations in which the heart rate is more than 15 beats above the basal heart rate and last more than 15 seconds It will be said to be) 2. Nonreactive (positive) non-stress test (Absence of fetal movements or presence of fetal movements within 20 minutes It will be defined as the presence of accelerations that are less than a beat and last less than 15 seconds) 3. Questionable non-stress test evaluation was performed.
Satisfaction Evaluation Scale
Time frame: Immediately after non-stress test
This scale was adapted by researchers similar to the "Visual Analog Scale " usage principles. Visual Analog Scale is a scale evaluated by individuals by making marks on a horizontal or vertical line of 10 cm or 100 mm, one end of which indicates that the individual is "very good" and the other end indicates that the individual is "very bad". This line can be just a straight line or evenly spaced.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Yasemin Sökmen, Dr principal investigator
Ondokuz Mayıs University
Resmiye Kaya Odabaş, Dr study chair
Kocaeli University
Bahadır Yazıcıoğlu, Dr study chair
Samsun Provincial Health Directorate
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, run by Resmiye KAYA ODABAŞ 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 13 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 21 Nov 2023. 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?
Results are not available in the source record.
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?
Fetal heart rate (time frame: Immediately after non-stress test). The study lists 9 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 21 Nov 2023.