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Not yet recruiting NCT07231562

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

No phase Interventional Lumbar Disease Lumbar Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: The group that will receive mobilization training using virtual reality glasses and brochures.
Who it may be relevant to
Registry conditions: Lumbar Disease, Lumbar Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other 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).

Primary outcome measures

  • Tampa Kinesiophobia Scale (TKS) [Time frame: eight months]
  • Patient Mobility Scale-HHO [Time frame: eight months]
Secondary outcome measures (5)
  • 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Eskişehir Şehir Hastanesi — Eskişehir

Identifiers

NCT: NCT07231562 · SDU-Hemsire-OÖ-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗