The Effect of Mobilization Protocol Assisted With Simulated Clinical Immersion Videos on Postoperative Pain, Fear of Movement, Mobility Level and Satisfaction in Patients Undergoing Lumbar Spine Surgery: A Randomized, Controlled, Single-Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Back and leg pain
研究概览
简要总结
This study focused on examining the effect of mobilization protocol assisted with simulated clinical immersion videos on postoperative pain, fear of movement, mobility level and satisfaction in patients undergoing lumbar spine surgery.
详细描述
Background: The medical condition that creates the need for lumbar spine surgery causes pain and movement restriction in patients. Ensuring safe mobilization in patients with lumbar spine surgery is important for pain management and prevention of complications.
Aim: In this study, it was aimed to examine the effect of mobilization protocol assisted with simulated clinical immersion videos on postoperative pain, fear of movement, movement level and satisfaction.
Study Design: The study was designed as interventional, pre-test, post-test, parallel group, single-blind, randomized, controlled and experimental. In the study, patients in the control group will be applied routine protocols, and patients in the intervention group will be trained on the day before surgery using the mobilization protocol assisted with simulated clinical immersion videos. In this study, the patients will be distributed to the groups by the "block randomization method".
Methods: In this study, pain, fear of movement, movement level and satisfaction will be recorded at the first postoperative mobilization and discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Participants and statistician are blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •According to the ICD-10 Codes: Those with S33.0-Traumatic rupture of lumbar intervertebral disc, G55-Nerve root and plexus compressions, M54.4-Lumbago with sciatica, underwent lumbar disc herniation surgery (microdiscectomy) due to diagnosed with M54.5-Low back pain,
- •Aged 18 and over,
- •With no hearing, vision, comprehension and speech impairments,
- •Volunteering to participate in the research,
- •Using a smartphone will be included in the study.
排除标准
- •Those under the age of 18,
- •Underwent revision lumbar spine surgery,
- •With mental or physical disabilities to receive the mobilization training that will be provided before the operation will not be included in the sample.
结局指标
主要结局
Back and leg pain
时间窗: Changes in hospitalization, first mobilization after surgery and the day of discharge. 1. Day of hospitalization (24 hours) 2. The first 24 hours after surgery 3. The day of discharge (24 hours)
The Visual Analog Scale (VAS) is a straight horizontal line of 100 mm. One end describes no paint at all while the other describes an excessive amount of pain. VAS score is calculated by measuring in millimeters from the left end of the line to the point marked by the patient. VAS will be used to assess low back pain (VAS-BP) and right and left leg pain (VAS-LP) separately (Nayak, Coats, Abdullah, Stein, \& Malhotra, 2015).
Mobility Level
时间窗: Changes in hospitalization, first mobilization after surgery and the day of discharge. 1. Day of hospitalization (24 hours) 2. The first 24 hours after surgery 3. The day of discharge (24 hours)
Patient Mobility Scale: The level of pain and difficulty that patients experience doing four activities (turning from side to side in bed, sitting on the edge of the bed, sitting up at the side of the bed, walking in hospital room) during the postoperative period are assessed using a 15-cm visual analogue, throughout which verbal expressions are included. The lowest and highest possible scores obtained from each item ranges between 0 and 15, and the overall scale score ranges between 0 and 120. Higher scores indicate higher level of pain and difficulty (Ayoğlu, 2011).
Fear of Movement
时间窗: Changes in hospitalization, first mobilization after surgery and the day of discharge. 1. Day of hospitalization (24 hours) 2. The first 24 hours after surgery 3. The day of discharge (24 hours)
Tampa Scale for Kinesiophobia (TKS): The TKS is used to assess the subjective degree of kinesiophobia or fear of movement, and consists of 17 items. The 4-point Likert-type scale ranges from 1 to 4 (1=Strongly disagree, 4=Completely agree). The overall score is calculated after reverse scoring the items 4, 8, 12 and 16. The overall scale score ranges between 17 and 68, and higher scores indicate higher level of kinesiophobia (Yılmaz et al., 2011).
次要结局
- Patient Satisfaction(The day of discharge (24 hours))
研究者
Arş. Gör. Arzu TAT ÇATAL
Principal Investigator
Akdeniz University