- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07762183
Dependence, Frailty, and Kinesiophobia on Early Postoperative Mobilization and Self-Care Ability in Patients Undergoing Lumbar Disc Herniation Surgery
The Effect of Dependence, Frailty, and Kinesiophobia on Early Postoperative Mobilization and Self-Care Ability in Patients Undergoing Lumbar Disc Herniation Surgery: A Prospective Observational Study
Обзор исследования
Статус
Подробное описание
Lumbar disc herniation is one of the most common spinal disorders affecting functional capacity and quality of life. Although conservative treatment is effective for many patients, a substantial proportion require surgical intervention because of persistent symptoms or neurological impairment. The primary goals of surgery are pain relief, prevention of complications, restoration of functional independence, and improvement of quality of life.
Recovery after lumbar disc herniation surgery varies considerably among individuals. Factors such as dependency in activities of daily living, frailty, and kinesiophobia may influence patients' ability to mobilize early after surgery and perform self-care activities. Dependency reflects the level of assistance required for daily living activities, frailty indicates reduced physiological reserve and increased vulnerability to stressors, and kinesiophobia refers to an excessive fear of movement resulting from concerns about pain or reinjury. These characteristics may adversely affect postoperative recovery by limiting participation in early mobilization and delaying the restoration of self-care ability.
Although previous studies have examined the relationships between these variables and different health outcomes in various surgical populations, evidence regarding their combined influence on postoperative mobilization and self-care following lumbar disc herniation surgery remains limited. Identifying patients with unfavorable preoperative characteristics may facilitate early recognition of individuals at risk for delayed recovery and support the development of individualized nursing interventions.
This prospective observational study will be conducted in the Neurosurgery Clinic of Aydın Adnan Menderes University Research and Application Hospital. Adult patients scheduled for lumbar disc herniation surgery will be recruited consecutively. Data will be collected at two time points: one day before surgery and on the first postoperative day. Preoperative assessments will include a Patient Information Form, the Katz Activities of Daily Living Scale, the FRAIL Scale, and the Tampa Scale for Kinesiophobia. On the first postoperative day, mobilization will be evaluated using the Patient Mobility Scale and the Observer Mobility Scale, while self-care agency will be assessed using the Exercise of Self-Care Agency Scale.
The primary objective of the study is to determine the effects of preoperative dependency, frailty, and kinesiophobia on postoperative mobilization and self-care agency. The results are expected to contribute to the identification of modifiable preoperative factors influencing early postoperative recovery and provide evidence to support nursing assessment, perioperative care planning, and individualized rehabilitation strategies for patients undergoing lumbar disc herniation surgery.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
-
-
Zafer Mahallesi
-
Aydin, Zafer Mahallesi, Турция (Туркие), 09010
- Aydın Adnan Menderes University
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Aged 18 years or older
- Able to speak and understand Turkish
- Having no hearing impairment that would prevent communication
- Scheduled to undergo lumbar disc herniation surgery
- Conscious and clinically able to complete the preoperative assessments
- Conscious and clinically stable on postoperative day 1 to allow assessment of mobilization and self-care agency
- Voluntarily agreeing to participate in the study and providing informed consent
Exclusion Criteria:
- Having a diagnosed psychiatric disorder documented in the medical record or reported by the clinical team
- Being unable to complete the data collection forms because of cognitive, communication, or clinical limitations
- Developing a postoperative condition that prevents mobilization or self-care assessment on postoperative day 1
- Withdrawing consent at any stage of the study
Учебный план
Как устроено исследование?
Детали дизайна
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Frailty
Временное ограничение: One day before surgery (baseline)
|
Frailty will be assessed using the FRAIL Scale.
The scale consists of five items evaluating fatigue, resistance, ambulation, illnesses, and weight loss.
Higher scores indicate greater frailty.
The minimum score obtainable from the scale is between "0" (zero) and "5" (five).
There is no cutoff score for the scale; it is interpreted that an increase in the score indicates an increase in the level of vulnerability.
|
One day before surgery (baseline)
|
|
Dependency in Activities of Daily Living
Временное ограничение: One day before surgery (baseline)
|
Dependency will be assessed using the Katz Activities of Daily Living (ADL) Scale.
The instrument evaluates independence in six basic daily living activities.
As the scores obtained from the scale increase, it is interpreted as an increase in difficulty in performing daily living activities and an increase in dependence.
Based on the scores obtained from the scale, 0-2 is classified as dependent, 3-4 as semi-dependent, and 5-6 as independent.
|
One day before surgery (baseline)
|
|
Kinesiophobia
Временное ограничение: One day before surgery (baseline)
|
Kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia (TSK).
The questionnaire evaluates fear of movement and reinjury.
The minimum possible score on the scale is 17, and the maximum is 68.
A high score on the scale is interpreted as indicating a high level of kinesiophobia.
|
One day before surgery (baseline)
|
|
Postoperative Mobilization
Временное ограничение: Postoperative Day 1
|
Postoperative mobilization will be evaluated using the Patient Mobility Scale and the Observer Mobility Scale.
These instruments assess patients' ability to perform postoperative mobility activities and the level of independence during mobilization.
The Patient Mobility Scale assesses the level of pain and difficulty experienced during four post-surgical activities (turning from side to side in bed, sitting at the bedside, standing at the bedside, and walking around the hospital room) using a 15 cm visual analog with verbally displayed statements at the bottom of the scale.
The numerical value of the pain and difficulty level is determined by measuring the distance between the patient's mark on the scale and "0" using a calibrated ruler.
An increased score on the scale indicates that patients have inadequate mobility, while a decreased score indicates that their mobility is good/adequate after surgery.
|
Postoperative Day 1
|
|
Self-Care Agency
Временное ограничение: Postoperative Day 1
|
Self-care agency will be assessed using the Exercise of Self-Care Agency Scale.
Higher scores indicate greater self-care agency and a higher ability to perform self-care activities independently.
The minimum possible score on the scale is 0, and the maximum is 140.
A higher score indicates a higher level of self-care or self-reliance ability or strength in an individual.
|
Postoperative Day 1
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- Lumbar Disc Herniation
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
Сроки обмена IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .