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临床试验/NCT03792230
NCT03792230已完成不适用

Comparison Of The Effects Of Different Body Mechanics Education Methods On Pain, Disability And Quality Of Life: Randomised Controlled Study

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi2 个研究点 分布在 2 个国家目标入组 3 人开始时间: 2017年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3
试验地点
2
主要终点
Short-Form McGill Pain Questionnaire (SF-MPQ)

研究概览

简要总结

The study evaluated the comparison of the different patient education methods. The study involved two stages of data collection: one during the preoperative period, the other during the sixth postoperative week.

详细描述

Before commencing the study, we informed participants who met the inclusion criteria about the scope of the study and obtained their written and oral consent. Participants in each group completed the data collection form regarding patients' characteristics, the SF-MPQ, the ODI and the Physical Functioning and Bodily Pain subscales of the SF-36. A day before LDH (Lumbar Disc Hernia) surgery, participants in the control group received standard clinical education, whereas ones in the intervention groups received either video- or brochure-based education. Participants in the brochure group learned about the proper use of body mechanics from the "Body Mechanics Educational Brochure for LDH Patients" and demonstrations performed by primary investigator after which we answered any questions that participants asked. Brochure-based education took nearly 15 min, and participants could keep the brochures after the education programme ended. By contrast, participants in the video group learned about proper use of body mechanics from the "Body Mechanics Educational Video for LDH Patients" presented on a laptop, after which we also answered any questions that participants asked. Video-based education took nearly 15 min, and we provided CD-ROM with the video to the participants. Unlike participants in the intervention groups, ones in the control group did not receive structured education. Clinical nurses orally informed them about points to consider while performing activities such as standing, rising from bed and lifting. Final data collection took place in the sixth postoperative week, following the statement of the American Association of Neuroscience Nurses that pain and disability begin to decrease and that quality of life begins to increase 4-6 weeks after thoracolumbar surgery (Starkweather et al., 2013). During the postoperative period, participants in all groups completed the SF-MPQ, the ODI and the Physical Functioning and Bodily Pain subscales of the SF-36. Participants in the brochure and video groups also completed the survey addressing their satisfaction with the educational materials, whereas ones in the control group completed the survey addressing their satisfaction with the clinical education that they received. We collected data face-to-face with participants, which took approximately 20 min. Participants who lived outside Ankara completed the respective survey via telephone interviews, which took approximately 30 min.

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
Single (Investigator)

盲法说明

Because of only one investigator, there is no blinding

入排标准

年龄范围
18 Years 至 78 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients hospitalised in preparation to receive LDH surgery and who volunteered to participate
  • Older than 18 years
  • Could read and write in Turkish
  • Scored between 1 and 3 in the classification systems of the American Society of Anesthesiologists were preparing for their first LDH surgical operation
  • Could use CD-based educational materials

排除标准

  • Patients hospitalised in preparation to receive LDH surgery and who unvolunteered to participate
  • All potential participants who had previously undergone LDH surgery
  • Could not use CD-based educational materials or had mental disorders liable to prevent communication

结局指标

主要结局

Short-Form McGill Pain Questionnaire (SF-MPQ)

时间窗: Change from pain at 6 weeks

This questionnaire evaluated the reliability and validity of the Turkish version of the instrument. The scale evaluates acute pain and consists of sensory, affective and intensity subscales; higher scores indicate a higher intensity of pain.

Subscales of the Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36)

时间窗: Change from quality of life at 6 weeks

Of the instrument's eight subscales and 36 items, we used the Physical Functioning (i.e. 10 items) and Bodily Pain (i.e. 2 items) subscales. Final scores for each subscale are calculated by dividing the score obtained by the number of items on the subscale. Final scores on the subscales range from 0 to 100; higher scores indicate higher quality of life

Oswestry Disability Index (ODI)

时间窗: Change from disability at 6 weeks

The ODI has 10 questions addressing the intensity of pain, personal care, walking, sitting, standing and lifting behaviours, sex life, social life, sleep routines and travelling tendencies. Patients respond to each question on a 6-point Likert scale; for each question, scores range from 0 (i.e. no disability) to 5 (i.e. most severe disability). By contrast, total scores range between 0 and 50 and are interpreted to indicate minimal disability (0-4 points), moderate disability (5-14 points), severe disability (15-24 points), crippled (25-34 points) or bed-bound (35-50 points)

次要结局

未报告次要终点

研究者

发起方
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ozgu Bakcek

Master of Science

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

研究点 (2)

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