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| ID | Type | Description | Link |
|---|---|---|---|
| 2169 (Ethics decision number) | Other Identifier | Non-Interventional Clinical Research Ethics Committee of the Republic of Türkiye Izmir Bakırçay University |
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Music has direct and indirect positive effects on the mother and fetus during pregnancy and perinatal period. This study was aimed at investigating effects of music played during the Non-Stress Test (NST) procedure on the mother's comfort, vital signs and anxiety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music Group | Experimental | After the pregnant women were positioned, while the NST procedure was implemented they listened to music for 20-30 minutes. The pregnant women listened to the music on an MP3 player during the application. The duration of the music recorded on the MP3 player was 30 minutes. The music played to the pregnant women was selected by the researchers in accordance with the definition of relaxing music made in the literature. Before the music selection, the researchers communicated with the TÃœMATA (Turkish acronym for the "Research and Promotion of Turkish Music Association). After the meeting held with the association, it was decided to use the 'AcemaÅŸiran' (a musical mode in traditional Turkish music). In the study, music prepared by the TÃœMATA in the AcemaÅŸiran mode was played. It is stated that AcemaÅŸiran mode helps balance the body, helps the listener relax, facilitates birth, helps correct the wrong position of the fetus in the womb, and has a pain and spasm relieving effect |
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| Control Group | No Intervention | Pregnant women were not subjected to any intervention during the NST procedure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music intervention | Other | The music played to the pregnant women was selected by the researchers in accordance with the definition of relaxing music made in the literature. Before the music selection, the researchers communicated with the TÃœMATA (Turkish acronym for the "Research and Promotion of Turkish Music Association). After the meeting held with the association, it was decided to use the 'AcemaÅŸiran' (a musical mode in traditional Turkish music). In the study, music prepared by the TÃœMATA in the AcemaÅŸiran mode was played. It is stated that AcemaÅŸiran mode helps balance the body, helps the listener relax, facilitates birth, helps correct the wrong position of the fetus in the womb, and has a pain and spasm relieving effect. |
| Measure | Description | Time Frame |
|---|---|---|
| During Non-Stress Testing on Women's Comfort Level | Prenatal Comfort Scale (PCS) was used to determine women's comfort level. The short version of the PCS consists of 15 items. Response given to the items are rated on a six-point Likert type scale ranging from 0 to 5 (0 = Strongly disagree, 1 = Disagree, 2 = Undecided, 3 = Somewhat agree, 4 = Agree, 5 = Strongly agree). The minimum and maximum possible scores that can be obtained from the PCS are 0 and 75, respectively. The higher the score is the higher the comfort level is. | Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins) |
| During Non-Stress Testing on Women's Systolic Blood Pressure Level | The women's systolic blood pressure levels were measured with a calibrated electronic sphygmomanometer. Blood pressure levels are expressed in millimeters of mercury (mmHg). | Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins) |
| During Non-Stress Testing on Women's Diastolic Blood Pressure Level | The women's diastolic blood pressure levels were measured with a calibrated electronic sphygmomanometer. Blood pressure levels are expressed in millimeters of mercury (mmHg). | Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins) |
| During Non-Stress Testing on Women's Diastolic Heart Rate Level | Heart rate level was determined electronically. Heart rate level was recorded in beats per minute (bpm). | Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins) |
| During Non-Stress Testing on Women's Anxiety Level |
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Inclusion Criteria:
Exclusion Criteria:
Participation in the study was restricted based on biological sex. Because the study included pregnant women, biologically female individuals were eligible to participate.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University District, 2076 Street, No: 11 | Karaman | Central | 70200 | Turkey (Türkiye) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 29, 2025 | Nov 23, 2025 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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Simple randomization method was used in this study. Pregnant women who met the study criteria were randomly assigned to the music or control group with equal probability, independently of any previous assignments, on the day they came to the hospital for their physical examination. The total number of pregnant women determined by the G*Power analysis was entered into the program at ''https://www.randomizer.org," and randomization was conducted using the program. The assignment of the groups was performed on the computer, and the pregnant women were randomly assigned to the music and control groups. The data of the study were collected from the pregnant women using the face-to-face interview technique at the NST outpatient clinic on the days and hours when the researcher was present in the hospital.
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The participating pregnant women were not informed of the group they belonged to. Since only the researcher knew the participants' groups, single-blindness was achieved in the study.
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State Anxiety Scale (SAS) was used to determine the anxiety level. The scale is a 4-point Likert type, "not at all" (1), "somewhat" (2), "moderately" (3), "very much" (4). The scale consists of 20 items and items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 are reverse scored. To calculate the total score of the SAS, the total score of the reversed items is subtracted from the total score of the non-reversed items. Then, 50 points, which is the constant value of the state anxiety scale, are added to this score. The result is the score for the overall SAS. The total score varies between 20 and 80. The higher the score is the higher the level of the anxiety is. While a score ranging between 0 and 19 indicates "no anxiety", a score ranging between 20 and 39 indicates mild anxiety, a score ranging between 40 and 59 indicates moderate anxiety, a score ranging between 60 and 79 indicates severe anxiety, and a score of 80 indicates very severe anxiety (Panic).
| Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins) |