CClinicalTrials.gg
Not yet recruitingNCT07231562Updated Nov 17, 2025

The Effect of Mobilization Training Given to Patients Undergoing Lumbar Stabilization Surgery on Postoperative Pain, Anxiety, Kinesiophobia, Fear of Falling, and Mobility

An interventional study of The group that will receive mobilization training using virtual reality glasses and brochures in Lumbar Disease and Lumbar Surgery, sponsored by Suleyman Demirel University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by Suleyman Demirel University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

In this study, the researcher will examine the effects of preoperative mobilization training (video viewing with VR glasses and brochure methods) given to patients undergoing surgery in the lumbar region on pain, anxiety, fear of movement, fear of falling, and mobility levels in the postoperative period, using specific scales.

Read the detailed description

Conditions requiring surgical intervention in the lumbar region include various pathological conditions such as lumbar disc herniation, spinal cord tumors, traumatic spinal injuries, and spinal stenosis. Surgical interventions such as stabilization, fusion, laminectomy, and discectomy are commonly performed for these conditions. The study is a randomized controlled comparative study. The study sample will consist of patients admitted to the Neurosurgery-I and Neurosurgery-II clinics of Eskişehir City Hospital before surgery and transferred back to the clinic after surgery. The study sample is planned to include 60 patients in the intervention group and 60 in the control group. Pre-test data will be collected in the preoperative period from patients in the intervention and control groups who agreed to participate in the study in accordance with the informed consent form and gave their consent using the Informed Consent Form, the Patient Information Form, the State-Trait Anxiety Scale, the Tampa Kinesiophobia Scale, the Likert-Type Fear of Falling Scale, the Visual Analog Scale, the Patient Mobility Scale, and the Observer Mobility Scale. Afterwards, patients in the intervention group will be trained on mobilization by watching a video using VR headsets and using a brochure. Patients in the control group will not receive any video or brochure training other than during the routine mobilization process in the ward. The brochure given to the intervention group will include mobilization and information included in the video viewing using VR headsets and will be given to patients so they can open and read it at any time. During the first mobilization of patients in the intervention and control groups, a "Patient Information Form" will be filled out before mobilization. Data will be collected again using the "State-Trait Anxiety Scale," "Tampa Kinesiophobia Scale," "Likert-Type Fear of Falling Scale," and "Visual Analog Scale." Patients in the intervention group will then be mobilized appropriately using a video and brochure training program shown through virtual reality glasses regarding the mobilization steps. Patients in the control group will be mobilized using the mobilization steps routinely performed in the ward. After the initial mobilization of patients in both groups, data will be collected and recorded again using the "Visual Analog Scale," "Patient Mobility Scale," and "Observer Mobility Scale." As a posttest, before the final mobilization of patients in the intervention and control groups before discharge, they will complete the "Patient Information Form," "State-Trait Anxiety Scale," and "Tampa Kinesiophobia Scale." Post-test data will be collected using the "Likert-Type Fear of Falling Scale," "Visual Analog Scale," and "Visual Analog Scale." Post-test data will be collected and recorded 5-10 minutes after mobilization is achieved using the "Visual Analog Scale," "Patient Mobility Scale," and "Observer Mobility Scale." Data will be collected face-to-face by the researchers. Ethics committee approval, Turkish Medicines and Medical Devices Agency (TİTCK), and institutional permissions have been obtained for the study. Patients will also provide informed consent in accordance with the Informed Consent Form. Statistical analyses will be performed using computer software using numbers, percentages, means, standard deviations, t-tests, and chi-square tests.

02

Conditions studied

  • Lumbar Disease
  • Lumbar Surgery

Keywords

  • Lumbar region
  • kinesiophobia
  • mobilization
  • nursing care and education
  • perioperative period
03

In context

Disease

1,327 studies on the registry are indexed under Disease; 596 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 732 interventional studies indexed under Disease.

Browse Disease studies →

Lead sponsor

Suleyman Demirel University is the lead sponsor of 123 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

İnclusion Criteria

  • The patient must be over 18 years of age
  • Participate in the study voluntarily,
  • Be undergoing lumbar surgery for the first time
  • Be undergoing lumbar stabilization surgery
  • Be oriented to person, place, and time
  • Not have taken any oral or parenteral analgesic medication other than the routine treatment ordered before mobilization
  • Have no restrictions (physical disability, etc.) that would prevent mobilization,
  • Be able to understand and speak Turkish
  • Have no vision or hearing problems,
  • Have no psychiatric illness, ağrı var
  • Be in ASA 1 or 2,
  • Patients planned to be included in the intervention and control groups must not be in the same rooms.

Exclusion Criteria

  • Having a neurological (such as dementia/Alzheimer's) or psychiatric (such as schizophrenia) medical diagnosis that affects cognitive status.
  • Having a chronic pain disorder.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    intervention group

    A group of 30 patients who will receive training on mobilization by watching videos and brochures using virtual reality glasses during the preoperative period (Intervention group).

    Other: The group that will receive mobilization training using virtual reality glasses and brochures

  • No intervention
    control group

    A group of 30 patients who did not receive any video or brochure training other than the routine mobilization process during the preoperative period, and whose differences were examined and compared with those in the intervention group (control group).N

Interventions

  • OtherThe group that will receive mobilization training using virtual reality glasses and brochures

    A group of 30 patients who will receive training on mobilization by watching videos and brochures using virtual reality glasses during the preoperative period (Intervention group).

    Also known as: the group to be given mobilization training

06

What researchers measure

Primary outcomes

  1. Tampa Kinesiophobia Scale (TKS)

    The TSK is a 17-question scale developed to determine the level of injury/re-injury and fear-avoidance processes associated with activities. The scale is scored using a four-point Likert scale: "1 = Strongly Disagree," "2 = Disagree," "3 = Agree," and "4 = Strongly Agree." The minimum score on the scale is 17, while the maximum score is 68.

    Time frame: eight months

  2. Patient Mobility Scale-HHO

    The Patient Mobility Scale consists of eight items and four subscales: turning from side to side in bed, sitting at the edge of the bed, standing at the edge of the bed, and walking in the patient's room. The level of pain and difficulty experienced is assessed using a 15-cm visual analog with verbal statements listed below the scale. The numerical value of the degree of pain and difficulty is determined by measuring the distance between the patient's mark on the scale and "0" using a calibrated ruler (no pain, some pain, moderate pain, a lot of pain, the worst pain I can imagine/very easy, easy, a little difficult, difficult, very difficult). The lowest and highest scores for each item range from 0 to 15, and the total scale score ranges from 0 to 120.

    Time frame: eight months

Secondary outcomes

  1. Observer Mobility Scale-GHÖ

    The Observer Mobility Scale provides global observations of four subscales: turning from side to side in bed, sitting at the edge of the bed, standing up at the edge of the bed, and walking in the patient's room. Each subscale is scored from 1 to 5, with a score of 1 indicating that the patient independently performs the movement without verbal prompting or physical assistance, and a score of 5 indicating that the patient is unable to perform the movement despite verbal prompting or physical assistance. The lowest possible score on the scale is 4, and the highest is 20.

    Time frame: eight months

  2. Visual Anolog Skala-VAS

    This scale is a 10-cm ruler, with a minimum value of 0 on one end and a maximum value of 10 on the other. The patient is explained that there are two extremes, and that they are free to mark any point between them that matches the intensity of their pain. The distance between the onset of "no pain" and the point marked by the patient is measured in centimeters and recorded.

    Time frame: eight months

  3. State and Trait Anxiety Scale

    State Anxiety Scale (items 1-20): * Determines an individual's current anxiety level. * Contains 10 direct and 10 reversed statements. * Direct and reversed statements are scored differently. * Calculation: (Total direct statements - Total reverse statements) + 50. Trait Anxiety Scale (items 21-40): * Measures an individual's general tendency to anxiety. * Contains 13 direct and 7 reversed statements. * Calculation: (Total direct statements - Total reverse statements) + 35. * Score Range: Both scales yield scores between 20-80. * 0-19: No anxiety * 20-39: Mild anxiety 40-59: Moderate anxiety 60-79: Severe anxiety (60 and above requires professional help).

    Time frame: eight months

  4. Likert-Type Fear of Falling Scale

    The Likert-type scale includes the question, "Are you afraid of falling?" and the answers, "I am very afraid, I am moderately afraid, I am slightly afraid, and I am not afraid at all." The scale consists of a minimum of one (1) and a maximum of four (4) points (12). The scale will be used in this study to determine the level of fear of falling in patients.

    Time frame: eight months

  5. Patient Information Form

    It was developed by the researcher based on literature. It includes questions regarding the patients' age, gender, height, weight, marital status, and educational background. It also includes questions regarding clinical characteristics such as the presence of chronic disease, history of preoperative activity limitation, and history of previous spinal surgery.

    Time frame: eight months

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Study locations

1 site
  • Eskişehir Şehir Hastanesi
    Eskişehir, Odunpazarı 26080, Turkey (Türkiye)
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References and documents

Related links

Individual participant data

Plan to share: No — We do not want to share the IPD without any justification.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07231562
Lead sponsor
Suleyman Demirel University
Responsible party
Oğuz Özdemir (Principal Investigator, Suleyman Demirel University) — Principal investigator
First posted
Nov 17, 2025
Start date
Nov 2025 (estimated)
Primary completion
Nov 2025 (estimated)
Completion
Jul 2026 (estimated)
Last update
Nov 17, 2025

Study contacts

Oğuz ÖZDEMİR, Graduate Student
Contact
oguz85983@gmail.com
+90 545 735 5148
Oğuz ÖZDEMİR
principal investigator · Suleyman Demirel University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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