Lumbar DiseaseNCT07231562
The Effect of Mobilization Training Given to Patients Undergoing Lumbar Stabilization Surgery on Postoperative Pain, Anxiety, Kinesiophobia, Fear of Falling, and Mobility
A study testing The group that will receive mobilization training using virtual reality glasses and brochures in people with Lumbar Disease and Lumbar Surgery, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Disease, Lumbar Surgery
- What is being tested?
- The group that will receive mobilization training using virtual reality glasses and brochures
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
None listed.
Who cannot join
- Having a neurological (such as dementia/Alzheimer's) or psychiatric (such as schizophrenia) medical diagnosis that affects cognitive status.
- Having a chronic pain disorder.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Eskişehir Şehir Hastanesi
Eskişehir, Odunpazarı, 26080
Oğuz Özdemir, Hemşire, +90 545 735 5148, oguz85983@gmail.com
About this study
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.
- Conditions
- Lumbar Disease, Lumbar Surgery
- Being tested
- The group that will receive mobilization training using virtual reality glasses and brochures
- Keywords
- Lumbar region, kinesiophobia, mobilization, nursing care and education, perioperative period
- Medical subject headings
- Disease, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The group that will receive mobilization training using virtual reality glasses and brochuresOther
Also called the group to be given mobilization training
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).
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | 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). Receives: Other: The group that will receive mobilization training using virtual reality glasses and brochures |
| control group | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: eight months
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.
Measured: eight months
Secondary outcomes (5)
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.
Measured: eight months
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.
Measured: eight months
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).
Measured: eight months
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.
Measured: eight months
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.
Measured: eight months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study startNov 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- an intervention group that would receive mobilization training and a control group that would not receive training.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oğuz Özdemir, Suleyman Demirel University
- Investigators
- Oğuz ÖZDEMİR, Principal investigator, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07231562
- Sponsor's protocol ID
- SDU-Hemsire-OÖ-001
- Status last verified
- Nov 2025
- First submitted
- 1 Oct 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not want to share the IPD without any justification.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobilization Training Given to Patients Undergoing Lumbar Stabilization Surgery on Postoperative Pain, Anxiety, Kinesiophobia, Fear of Falling, and Mobility
- ClinicalTrials.gov ID
- NCT07231562
- Acronym / sponsor ID
- SDU-Hemsire-OÖ-001
- Conditions
- Lumbar Disease, Lumbar Surgery
- Keywords
- Lumbar region, kinesiophobia, mobilization, nursing care and education, perioperative period
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- Nov 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 17 Nov 2025 (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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- an intervention group that would receive mobilization training and a control group that would not receive training.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: The group that will receive mobilization training using virtual reality glasses and brochuresA 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). |
| control group | No intervention | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Having a neurological (such as dementia/Alzheimer's) or psychiatric (such as schizophrenia) medical diagnosis that affects cognitive status.
- Having a chronic pain disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The group that will receive mobilization training using virtual reality glasses and brochuresAlso: the group to be given mobilization trainingA 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 | intervention group |
Primary outcome
Tampa Kinesiophobia Scale (TKS)
Time frame: eight months
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.
Patient Mobility Scale-HHO
Time frame: eight months
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.
5 secondary outcomes
Observer Mobility Scale-GHÖ
Time frame: eight months
Visual Anolog Skala-VAS
Time frame: eight months
State and Trait Anxiety Scale
Time frame: eight months
Likert-Type Fear of Falling Scale
Time frame: eight months
Patient Information Form
Time frame: eight months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Ko, SY, Leung, DY, \& Wong, EM (2019). Effects of easy-listening music intervention on satisfaction, anxiety, and pain in patients undergoing colonoscopy: a pilot randomized controlled trial. Clinical interventions in aging, 14 , 977-986.Link provided by the sponsor.
- Öztaş B, Kara B, Zengin H, Güçlü A, On B. The Effect of Simulation Laboratory Education on Intravenous Catheterization Skills of Nursing Students. HUHEMFAD. 2022;9(1):17-23.Link provided by the sponsor.
- Vlaeyen JW, Kole-Snijders AM, Boeren RG, Van Eek H. Fear of movement/(re)injury in chronic low back pain and its relation to behavioral performance. Pain. 1995; 62(3): 363-372.Link provided by the sponsor.
- Biçer B. The effect of fear of falling on mobilization-induced fear of movement and fall risk in patients undergoing surgery. Dokuz Eylül University, Institute of Health Sciences, Unpublished Master's Thesis, İzmir, (Assoc. Prof. Dr. Özlem Bilik), 2019;Link provided by the sponsor.
- Çilingir D, Uzun Şahin C. I woke up early and went ahead: Evidence-based practices in postoperative planned mobilization. Gürsoy A, editor. Evidence-Based Practices in Perioperative Nursing. 1st ed. Ankara: Türkiye Clinics; 2020. p.35-9Link provided by the sponsor.
- Geçit S, Özbayır T. Protocol and nursing for accelerating recovery after spinal cord surgery. Özbayır T, editor. Protocol and nursing for accelerating recovery after surgery. 1st ed. Ankara: Türkiye Clinics; 2021. p.83-9.Link provided by the sponsor.
- Individual participant dataSharing planned: No. We do not want to share the IPD without any justification.
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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.
Oğuz ÖZDEMİR principal investigator
Suleyman Demirel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The group that will receive mobilization training using virtual reality glasses and brochures in people with Lumbar Disease and Lumbar Surgery, run by Suleyman Demirel 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 0 inclusion and 2 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: opening soon, as of the sponsor's last update on 17 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oğuz ÖZDEMİR, Graduate Student (+90 545 735 5148, oguz85983@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tampa Kinesiophobia Scale (TKS) (time frame: eight months). The study lists 2 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 17 Nov 2025.