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

NCT ID: NCT07231562

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Lumbar Disease Lumbar Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

an intervention group that would receive mobilization training and a control group that would not receive training.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

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

Intervention Type OTHER

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).

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

The 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).

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

the group to be given mobilization training

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Suleyman Demirel University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Oğuz Özdemir

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Oğuz ÖZDEMİR

Role: PRINCIPAL_INVESTIGATOR

Suleyman Demirel University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Eskişehir Şehir Hastanesi

Eskişehir, Odunpazarı, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Oğuz ÖZDEMİR, Graduate Student

Role: CONTACT

+90 545 735 5148

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Oğuz Özdemir, Hemşire

Role: primary

+90 545 735 5148

Related Links

Access external resources that provide additional context or updates about the study.

https://doi.org/10.2147/CIA.S207191

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.

https://doi.org/10.31125/hunhemsire.1101859

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.

https://pubmed.ncbi.nlm.nih.gov/8657437/

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.

https://tez.yok.gov.tr/UlusalTezMerkezi/tezDetay.jsp?id=-tBkg4xjGrh-tKJmmKpL5w&no=tMPVR0b4WsdporjxFt3nWg

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;

https://www.turkiyeklinikleri.com/article/tr-erken-kalktim-yol-aldim-postoperatif-planli-mobilizasyonda-kanita-dayali-uygulamalar-89613.html

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.35-9

https://www.turkiyeklinikleri.com/article/tr-spinal-kord-cerrahisi-sonrasi-yilesmenin-hizlandirilmasi-protokolu-ve-hemsirelik-94301.html

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.

https://www.turkiyeklinikleri.com/article/tr-ameliyat-sonrasi-hastalarin-ayaga-kalkma-durumlarini-etkileyen-faktorlerin-ncelenmesi-83625.html

Mahmudova R, Dönmez YC. Investigation of factors affecting the ability of patients to stand up after surgery. Turkish Clinics Journal of Nursing Sciences 2019; 11(1).

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SDU-Hemsire-OÖ-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.