跳至主要内容
临床试验/NCT07231562
NCT07231562尚未招募不适用

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

Suleyman Demirel University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
试验地点
1
主要终点
Tampa Kinesiophobia Scale (TKS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •xclusion 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.

研究组 & 干预措施

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).

干预措施: The group that will receive mobilization training using virtual reality glasses and brochures (Other)

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

结局指标

主要结局

Tampa Kinesiophobia Scale (TKS)

时间窗: 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

时间窗: 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.

次要结局

  • Observer Mobility Scale-GHÖ(eight months)
  • Visual Anolog Skala-VAS(eight months)
  • State and Trait Anxiety Scale(eight months)
  • Likert-Type Fear of Falling Scale(eight months)
  • Patient Information Form(eight months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Oğuz Özdemir

Principal Investigator

Suleyman Demirel University

研究点 (1)

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