- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07651228
Effect of ASMR and White Noise on Sleep Quality in Patients Undergoing Elective Lower Extremity Surgery (SLEEP-ASMR)
Effect of ASMR and White Noise on Sleep Quality in Patients Undergoing Elective Lower Extremity Surgery: A Randomized Controlled Trial
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Sleep disturbance is one of the most common postoperative complications following orthopedic surgery and is associated with increased pain perception, delayed recovery, prolonged hospitalization, and decreased patient comfort. Non-pharmacological interventions that improve sleep quality may contribute positively to postoperative recovery and patient outcomes.
Autonomous Sensory Meridian Response (ASMR) is characterized by relaxing sensory experiences triggered by auditory stimuli and has recently gained attention for its potential effects on sleep and emotional well-being. White noise is another auditory intervention commonly used to reduce environmental noise perception and promote sleep quality. Although previous studies have demonstrated beneficial effects of ASMR and white noise separately, there is limited evidence comparing these interventions in postoperative orthopedic patients.
This study is designed as a three-arm parallel randomized controlled trial conducted in patients undergoing elective lower extremity surgery. Eligible participants will be randomized in a 1:1:1 ratio into ASMR, white noise, or control groups using computer-generated block randomization. Participants in the intervention groups will listen to standardized 30-minute audio recordings before sleep during the postoperative hospitalization period. The control group will receive headphones without audio playback to minimize environmental noise exposure.
The primary outcome of the study is postoperative sleep quality measured using the Richards-Campbell Sleep Questionnaire (RCSQ). Secondary outcomes may include postoperative pain intensity, nocturnal awakening frequency, and patient comfort. Blinded researchers will perform outcome assessment and statistical analyses.
The findings of this study are expected to provide evidence regarding effective non-pharmacological nursing interventions to improve postoperative sleep quality in orthopedic surgery patients.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Müzeyyen Ataseven, PhD, RN
- Número de teléfono: +905052299474
- Correo electrónico: muzeyyenataseven@hotmail.com
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye), 34810
- Fatih Sultan Mehmet Training and Research Hospital
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Contacto:
- Müzeyyen Ataseven, PhD, RN
- Número de teléfono: +905052299474
- Correo electrónico: muzeyyenataseven@hotmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age 18 years and older
- Undergoing elective lower extremity surgery
- Conscious and able to communicate
- No hearing impairment or hearing aid use
- Numeric Rating Scale (NRS) pain score of 5 or lower
- No use of medications affecting sleep
- Willing to participate in the study
- Able to provide written informed consent
Exclusion Criteria:
- Participation in another clinical study
- Surgery due to trauma
- Transfer to the intensive care unit during the postoperative period
- Development of serious postoperative complications
- Withdrawal from the study at any stage
- Failure to comply with study procedures
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: ASMR Group
Participants will listen to standardized 30-minute ASMR audio recordings before sleep during the postoperative hospitalization period.
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Standardized ASMR audio recordings administered for 30 minutes before sleep during the postoperative period.
Otros nombres:
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Experimental: White Noise Group
Participants will listen to standardized 30-minute white noise audio recordings before sleep during the postoperative hospitalization period.
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Standardized white noise audio recordings administered for 30 minutes before sleep during the postoperative period.
Otros nombres:
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Sin intervención: Control Group
Participants will receive routine postoperative care and will wear headphones without audio playback before sleep.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Postoperative Sleep Quality
Periodo de tiempo: Postoperative nights 1 and 2
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Postoperative sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ).
The RCSQ is a validated five-item visual analog scale evaluating sleep depth, sleep latency, number of awakenings, sleep efficiency, and overall sleep quality.
Each item is scored between 0 and 100, and higher scores indicate better sleep quality.
Total scores are calculated by averaging the item scores.
Sleep quality will be evaluated during postoperative nights 1 and 2.
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Postoperative nights 1 and 2
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Müzeyyen Ataseven, PhD,RN, Medipol University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- ASMR-2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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