- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07707401
Effectiveness of WeChat-Supported Neck Rehabilitation Exercises on Early Recovery After Thyroidectomy
9 de septiembre de 2026 actualizado por: Ling Zhan, Shanghai 6th People's Hospital
Effectiveness of WeChat-Supported Neck Rehabilitation Exercises on Early Recovery After Thyroidectomy: A Randomized Controlled Trial
This study aimed to evaluate the effectiveness, safety, and implementation outcomes of a WeChat mini program-supported tele-neck rehabilitation exercises for improving early postoperative neck recovery after thyroidectomy.
Descripción general del estudio
Estado
Reclutamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
200
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Ling Zhan, Dr
- Número de teléfono: +8615821120972
- Correo electrónico: rebecca0428zhan@163.com
Ubicaciones de estudio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200233
- Reclutamiento
- Shanghai Sixth People's Hospital
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Contacto:
- Ling Zhan, Doctor
- Número de teléfono: 08615821120972
- Correo electrónico: rebecca0428zhan@163.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Undergoing thyroid surgery
- Postoperative condition stable, with the attending physician assessing the patient as fit for neck movement
- Willing to participate in the study, complete scheduled follow-ups, and sign a written informed consent form
Exclusion Criteria:
- History of prior thyroid or neck surgery
- History of cervical spondylosis, cervical spine surgery, neck trauma, or other conditions affecting neck mobility
- Postoperative complications rendering the patient unsuitable for neck movement training, such as confirmed recurrent laryngeal nerve injury, chyle leak, or complications requiring reoperation or prolonged drainage, or incision infection
- Persistent postoperative dizziness or other conditions unsuitable for exercise
- Unable to use WeChat and lacking assistance from family members
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿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: WeChat-supported tele-rehabilitation group
Participants in the WeChat-supported tele-rehabilitation group received WeChat mini program-supported postoperative neck exercise management.
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WeChat mini program-supported neck exercise management includes daily exercise reminders, exercise check-ins, symptom reporting, automated abnormal symptom prompts, and standardized remote feedback from the research team.
This intervention consists of standard clinical postoperative care and discharge education, encompassing wound management, follow-up appointments, and generic neck activity guidelines.
Prior to discharge or upon clinical stability, participants undergo a one-time, face-to-face training session with research staff featuring practical exercise demonstrations and behavioral precautions, and are provided with identical instructional video materials for home reference.
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Comparador activo: Routine care group
Participants in the routine care group did not receive WeChat mini program-supported postoperative neck exercise management.
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This intervention consists of standard clinical postoperative care and discharge education, encompassing wound management, follow-up appointments, and generic neck activity guidelines.
Prior to discharge or upon clinical stability, participants undergo a one-time, face-to-face training session with research staff featuring practical exercise demonstrations and behavioral precautions, and are provided with identical instructional video materials for home reference.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Neck Pain and Disability Scale (NPDS) Score
Periodo de tiempo: Preoperative baseline; the day of drainage removal; and 7, 14, and 30 days after drainage removal
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The NPDS is used to evaluate post-surgical neck pain and its multi-dimensional impact on daily living, emotions, work, and social activities.
The total score ranges from 0 to 100, with higher scores representing more severe neck pain and structural functional impairment.
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Preoperative baseline; the day of drainage removal; and 7, 14, and 30 days after drainage removal
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Neck Movement Pain Score
Periodo de tiempo: Preoperative baseline; the day of drainage removal; and 7, 14, and 30 days after drainage removal
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Assessment of localized pain severity provoked during active cervical movements, including neck flexion, extension, left/right lateral flexion, and left/right rotation.
Each of the six movements is scored categorically as 0 (painless), 1 (mild pain), or 2 (severe pain), yielding a cumulative score range of 0 to 12. Higher total scores indicate more pronounced motion-induced cervical pain.
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Preoperative baseline; the day of drainage removal; and 7, 14, and 30 days after drainage removal
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Health-related quality of life
Periodo de tiempo: Preoperative baseline; the day of drainage removal; and 7, 14, and 30 days after drainage removal
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Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L).
The descriptive system assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five response levels for each dimension.
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Preoperative baseline; the day of drainage removal; and 7, 14, and 30 days after drainage removal
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Incidence of Surgical Complications and Intervention-Related Adverse Events
Periodo de tiempo: Up to 3 month post-operation
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Safety endpoints mapping the frequency and severity of post-surgical complications (e.g., wound bleeding/hematoma, incision dehiscence, surgical site infection) or any adverse events deemed by the investigator to be potentially related to the physical exercise regimen (e.g., severe motion-induced pain exacerbation, acute dizziness).
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Up to 3 month post-operation
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Cervical Range of Motion (ROM)
Periodo de tiempo: Preoperative baseline; the day of drainage removal; and 7, 14, and 30 days after drainage removal
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Objective clinical measurement of neck mobility, quantifying the exact degrees of cervical movement achieved during forward flexion, backward extension, left/right lateral flexion, and left/right rotation, assessed by a blinded investigator.
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Preoperative baseline; the day of drainage removal; and 7, 14, and 30 days after drainage removal
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rehabilitation adherence
Periodo de tiempo: Up to 1 month post-operation
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Adherence will be calculated as the number of completed prescribed rehabilitation sessions divided by the number of prescribed sessions during the corresponding assessment period, multiplied by 100%.
Higher percentages indicate better adherence.
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Up to 1 month post-operation
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Acceptability of postoperative rehabilitation
Periodo de tiempo: 30 days after drainage removal
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Acceptability of the postoperative rehabilitation program will be assessed using study-specific items addressing clarity of the rehabilitation guidance, usefulness of the educational materials, suitability, perceived safety, burden, confidence in recovery, overall satisfaction, and willingness to recommend the rehabilitation approach.
Each item is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).
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30 days after drainage removal
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
9 de septiembre de 2026
Finalización primaria (Estimado)
31 de diciembre de 2028
Finalización del estudio (Estimado)
30 de junio de 2029
Fechas de registro del estudio
Enviado por primera vez
13 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
13 de julio de 2026
Publicado por primera vez (Actual)
16 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
9 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Dolor
- Manifestaciones neurológicas
- Enfermedades del sistema endocrino
- Complicaciones Postoperatorias
- Procesos Patológicos
- Neoplasias por sitio
- Neoplasias
- Neoplasias de glándulas endocrinas
- Neoplasias de Cabeza y Cuello
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Enfermedades de la tiroides
- Dolor Postoperatorio
- Neoplasias de tiroides
Otros números de identificación del estudio
- 2026-KY-277(K)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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