- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07299214
Música durante la Prueba sin Estrés
El Efecto de la Música Durante la Prueba de No Estrés en la Comodidad, Signos Vitales y Ansiedad de las Mujeres: Un Estudio Aleatorizado Controlado
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Central
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Karaman, Central, Turquía (Türkiye), 70200
- University District, 2076 Street, No: 11
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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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Sin intervención: Control Group
Pregnant women were not subjected to any intervention during the NST procedure. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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During Non-Stress Testing on Women's Comfort Level
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- KMBU-NST-2025-01
- 2169 (Ethics decision number) (Otro identificador: Non-Interventional Clinical Research Ethics Committee of the Republic of Türkiye Izmir Bakırçay University)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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