- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07575594
The Use of White Noise and Quiet Time During Labor (White & Quiet)
The Effect of White Noise and Quiet Time Interventions During Labor on Labor Pain, Stress, and Satisfaction
Childbirth is defined as the process in which the fetus and its appendages are expelled from the uterus. The World Health Organization emphasizes that women should have a positive childbirth experience and recommends interventions that reduce pain and stress while increasing maternal satisfaction.
White noise, defined as continuous and monotonous sounds such as wave, water, or wind sounds, and quiet time, described as periods in which environmental noise is minimized, have been shown to reduce pain and stress and improve satisfaction in various patient groups. However, there is a lack of evidence regarding their effects during labor.
Therefore, this study was planned to evaluate the effects of white noise and quiet time interventions applied during labor on perceived labor pain, stress levels, and childbirth satisfaction.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Childbirth is defined as a process in which the fetus and its appendages are expelled from the uterus. The World Health Organization emphasizes that women should have a positive childbirth experience. During childbirth, care providers are recommended to implement interventions that reduce women's pain and stress and increase satisfaction.
White noise is defined as continuous and monotonous sounds such as wave, water, and wind sounds. It has been studied in postoperative patients, infants, and neonates.
Quiet time is defined as a period in which environmental sounds are minimized. It has been studied in postpartum women, patients in acute care units, nurses working in neonatal intensive care units, and infants.
White noise and quiet time interventions have been found to be methods used to reduce pain and stress and to increase satisfaction. However, no study has been found that evaluates the effects of white noise and quiet time interventions on pain, stress, and satisfaction during the childbirth process. Therefore, this study was planned to evaluate the effects of white noise and quiet time interventions applied during childbirth on the level of perceived labor pain, stress level, and childbirth satisfaction.
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
-
-
-
Istanbul, Turcja (Türkiye)
- Esenler Women's and Children's Diseases Hospital
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
Pregnant women aged 18-35 years Pregnant women without a diagnosis of high-risk pregnancy Pregnant women with a gestational age between 37-42 weeks Pregnant women who will have a vaginal delivery Pregnant women in the active phase of labor Pregnant women who can speak or understand Turkish Pregnant women carrying a singleton fetus Primiparous women
Exclusion Criteria:
Pregnant women in the latent phase of labor Pregnant women with hearing impairment Pregnant women who are illiterate Pregnant women with an indication for cesarean section Multiparous women
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
White Noise Group
Participants received white noise via Bluetooth headphones during active labor at 6 cm and 8 cm cervical dilation (15 minutes each, 50-65 dB).
Pain and stress were assessed using VAS, and maternal satisfaction was evaluated postpartum.
|
Participants received white noise intervention during the active phase of labor. At 4 cm cervical dilation, informed consent was obtained and baseline assessments including Demographic Information Form, Visual Analogue Scale (VAS) for pain, and Visual Analogue Scale for stress were completed. Routine care was provided. At 6 cm and 8 cm cervical dilation, participants were exposed to white noise (50-65 dB) via Bluetooth headphones for 15 minutes each session. Routine monitoring and standard obstetric care were continued. After interventions, pain and stress were reassessed using VAS. At the second postpartum hour, maternal satisfaction was assessed using the Maternal Satisfaction in Childbirth Scale. |
|
Quiet Time Group
At the beginning of the active phase (when cervical dilation was 4 cm), the participant was informed about the study and informed consent was obtained. The Demographic Information Form was completed, and pain was assessed using the Visual Analogue Scale (VAS), while stress was evaluated using a Visual Analogue Scale (VAS). Routine monitoring and standard care were provided. At 6 cm cervical dilation during the active phase, quiet time was provided for 15 minutes using Polter headphones. Routine monitoring and standard care were continued. At 8 cm cervical dilation during the active phase, quiet time was again provided for 15 minutes using Polter headphones. Routine monitoring and standard care were continued. After the intervention, pain was assessed using the Visual Analogue Scale (VAS), and stress was evaluated using a Visual Analogue Scale (VAS). At the second hour postpartum, the Maternal Satisfaction in Childbirth Scale was completed. |
Participants received quiet time intervention during the active phase of labor. At 4 cm cervical dilation, informed consent was obtained and baseline assessments including Demographic Information Form, Visual Analogue Scale (VAS) for pain, and Visual Analogue Scale for stress were completed. Routine care was provided. At 6 cm and 8 cm cervical dilation, a quiet environment was maintained using Polter headphones for 15 minutes per session. Routine monitoring and standard obstetric care were continued. After interventions, pain and stress were reassessed using VAS. At the second postpartum hour, maternal satisfaction was assessed using the Maternal Satisfaction in Childbirth Scale. |
|
Control Group
At the beginning of the active phase (when cervical dilation was 4 cm), the participant was informed about the study and informed consent was obtained. The Demographic Information Form was completed, and pain was assessed using the Visual Analogue Scale (VAS), while stress was evaluated using a Visual Analogue Scale (VAS). Routine monitoring and standard care were provided. The participant received routine care throughout the active phase. At the end of the phase, pain was assessed using the Visual Analogue Scale (VAS), and stress was evaluated using a Visual Analogue Scale (VAS). Routine care was continued. At the second hour postpartum, the Maternal Satisfaction in Childbirth Scale was completed. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Pain level during labor
Ramy czasowe: During labor, between 4-10 cm cervical dilation (latent and active phases)
|
Labor pain levels will be assessed using the Visual Analog Scale (VAS).
Measurements will be performed during the latent and active phases of labor at specific cervical dilation stages (4-10 cm).
|
During labor, between 4-10 cm cervical dilation (latent and active phases)
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2025/55
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .