NCT07762183

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 13, 2026

Completed
Last Updated

August 13, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

August 5, 2026

Last Update Submit

August 8, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    Postoperative Day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aydın Adnan Menderes University

Aydin, Zafer Mahallesi, 09010, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
3 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Research Assisstant (Principal Investigator)

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 13, 2026

Study Start

December 15, 2025

Primary Completion

February 15, 2026

Study Completion

June 15, 2026

Last Updated

August 13, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Shared Documents
STUDY PROTOCOL
Time Frame
12 months after publication

Locations