- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
Zafer Mahallesi
-
Aydin, Zafer Mahallesi, Turecko (Türkiye), 09010
- Aydın Adnan Menderes University
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Frailty
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- Lumbar Disc Herniation
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .