- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07299214
Musiikki ei-stressitestauksen aikana
Musiikin vaikutus raskauden aikaisen stressittömän seurannan aikana naisten mukavuuteen, elintoimintomerkkeihin ja ahdistuneisuuteen: Satunnaistettu kontrolloitu tutkimus
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.
Tutkimuksen yleiskatsaus
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Central
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Karaman, Central, Turkki (Türkiye), 70200
- University District, 2076 Street, No: 11
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Women aged 18-45 years
- Completion of at least the 32nd week of gestation
- No pregnancy-related risk factors (e.g., premature rupture of membranes, preeclampsia, gestational diabetes)
- No multiple pregnancy
- Normal blood pressure levels (not ≤80/60 mmHg and not ≥140/90 mmHg)
- Having eaten at least two hours before the NST procedure
- No smoking or alcohol consumption for at least two hours before the NST procedure
- Ability to communicate effectively
- No hearing impairment
- Voluntary participation in the study
Exclusion Criteria:
- Pregnant women with fetal distress
- Cases for whom the physician considered emergency intervention necessary
- Individuals with an impaired NST requiring immediate intervention
- Individuals with a diagnosed psychiatric disorder
- Individuals with hearing impairment
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Tukevaa hoitoa
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: Music Group
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 TÜMATA (Turkish acronym for the "Research and Promotion of Turkish Music Association). After the meeting held with the association, it was decided to use the 'Acemaşiran' (a musical mode in traditional Turkish music). In the study, music prepared by the TÜMATA in the Acemaşiran mode was played. It is stated that Acemaşiran 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 |
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 TÜMATA (Turkish acronym for the "Research and Promotion of Turkish Music Association). After the meeting held with the association, it was decided to use the 'Acemaşiran' (a musical mode in traditional Turkish music). In the study, music prepared by the TÜMATA in the Acemaşiran mode was played. It is stated that Acemaşiran 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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Ei väliintuloa: Control Group
Pregnant women were not subjected to any intervention during the NST procedure. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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During Non-Stress Testing on Women's Comfort Level
Aikaikkuna: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
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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)
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During Non-Stress Testing on Women's Systolic Blood Pressure Level
Aikaikkuna: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
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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)
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During Non-Stress Testing on Women's Diastolic Blood Pressure Level
Aikaikkuna: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
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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)
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During Non-Stress Testing on Women's Heart Rate Level
Aikaikkuna: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
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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)
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During Non-Stress Testing on Women's Anxiety Level
Aikaikkuna: Pre-test: Before NST application Post-test: After NST application (Approximately 20-30 minutes after the NST session begins)
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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)
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Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- KMBU-NST-2025-01
- 2169 (Ethics decision number) (Muu tunniste: Non-Interventional Clinical Research Ethics Committee of the Republic of Türkiye Izmir Bakırçay University)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
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