Nursing CareNCT07762183
Dependence, Frailty, and Kinesiophobia on Early Postoperative Mobilization and Self-Care Ability in Patients Undergoing Lumbar Disc Herniation Surgery
An observational study of Nursing Care and Spine Surgery, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Lumbar disc herniation is a common condition that may impair physical functioning and reduce independence in activities of daily living. Although surgery aims to relieve symptoms and improve functional recovery, individual factors present before surgery may influence postoperative rehabilitation outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nursing Care, Spine Surgery, Perioperative Care
- How many people
- 221 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2025to 15 Jun 2026
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (≥18 years) undergoing elective lumbar disc herniation surgery in the Neurosurgery Clinic of Aydın Adnan Menderes University Research and Application Hospital who meet the eligibility criteria and provide informed consent will be consecutively enrolled in the study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydın Adnan Menderes University
Aydin, Zafer Mahallesi, 09010
About this study
Official title: 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
Lumbar disc herniation is a common condition that may impair physical functioning and reduce independence in activities of daily living. Although surgery aims to relieve symptoms and improve functional recovery, individual factors present before surgery may influence postoperative rehabilitation outcomes. This prospective observational study aims to investigate the effects of preoperative dependency, frailty, and kinesiophobia on postoperative mobilization and self-care agency in patients undergoing lumbar disc herniation surgery. Data will be collected before surgery and on the first postoperative day using validated assessment instruments. The findings are expected to identify preoperative risk factors associated with early postoperative recovery and provide evidence to support individualized nursing care and rehabilitation planning.
Read the detailed description
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.
- Conditions
- Nursing Care, Spine Surgery, Perioperative Care
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty
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.
Measured: One day before surgery (baseline)
Dependency in Activities of Daily Living
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.
Measured: One day before surgery (baseline)
Kinesiophobia
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.
Measured: One day before surgery (baseline)
Postoperative Mobilization
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.
Measured: Postoperative Day 1
Self-Care Agency
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.
Measured: Postoperative Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start15 Dec 2025
- Primary completion15 Feb 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CareStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 221 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezgi Arslan, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762183
- Sponsor's protocol ID
- Lumbar Disc Herniation
- Status last verified
- Jun 2026
- First submitted
- 5 Aug 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07762183
- Acronym / sponsor ID
- Lumbar Disc Herniation
- Conditions
- Nursing Care, Spine Surgery, Perioperative Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lumbar disc herniation is a common condition that may impair physical functioning and reduce independence in activities of daily living. Although surgery aims to relieve symptoms and improve functional recovery, individual factors present before surgery may influence postoperative rehabilitation outcomes. This prospective observational study aims to investigate the effects of preoperative dependency, frailty, and kinesiophobia on postoperative mobilization and self-care agency in patients undergoing lumbar disc herniation surgery. Data will be collected before surgery and on the first postoperative day using validated assessment instruments. The findings are expected to identify preoperative risk factors associated with early postoperative recovery and provide evidence to support individualized nursing care and rehabilitation planning.
Detailed description
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (≥18 years) undergoing elective lumbar disc herniation surgery in the Neurosurgery Clinic of Aydın Adnan Menderes University Research and Application Hospital who meet the eligibility criteria and provide informed consent will be consecutively enrolled in the study.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frailty
Time frame: 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.
Dependency in Activities of Daily Living
Time frame: 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.
Kinesiophobia
Time frame: 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.
Postoperative Mobilization
Time frame: 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.
Self-Care Agency
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: Yes. The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nursing Care and Spine Surgery, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty (time frame: One day before surgery (baseline)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.