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临床试验/NCT04265313
NCT04265313Unknown不适用

Validity and Reliability of the Turkish Version of the Neck Dissection Impairment Index

Izmir Bakircay University1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2020年3月13日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
65
试验地点
1
主要终点
Neck Dissection Impairment Index

研究概览

简要总结

One of the long-term effects of neck dissection applied to patients with head and neck cancer is shoulder dysfunction, which directly affects the quality of life. Patients complain of different degrees of shoulder joint problems following neck dissection . Shoulder syndrome in these patients is characterized by a set of symptoms including shoulder pain, abduction limitation, and scapular winging.The aim of this study is to make the Turkish Neck validity, reliability and cultural adaptation of the "Neck Dissection Impairment Index".

详细描述

In the literature, there are many questionnaires aimed at patients with head and neck cancer, developed both specifically and specifically for this patient group, evaluating the quality of life. Regarding the shoulder problems experienced by these patients, there is only one item in the literature called "The University of Michegan Head and Neck QOL (UMHNQOL) questionnaire" that evaluates shoulder pain. Apart from this, there is no other questionnaire in the literature that may adversely affect the quality of life to neck dissection and question both neck and shoulder problems together. The Neck Dissection Impairment Index evaluates the shoulder-related quality of life in a more comprehensive and more detailed manner according to the UMHNQOL questionnaire. The Neck Dissection Impairment Index evaluates the components of shoulder related quality of life in a wide range after neck dissection. Because the type of age, weight, radiotherapy and neck dissection are the most important variables affecting quality of life, patients in the high-risk group (e.g. young individuals, patients who have received radiotherapy and modified radical neck dissection) evaluated with the Neck Dissection Impairment Questionnaire can benefit from an earlier and more intensive rehabilitation.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Voluntarily accepting to participate in the study
  • Patients whose native language is Turkish
  • Patients or healthy individuals who have completed a minimum 11-month recovery period after selective or modified neck dissection

排除标准

  • Having a pathological condition in the neck or shoulder that is not related to the treatments associated with head and neck cancer
  • Cancer recurrence at the time of the evaluations

结局指标

主要结局

Neck Dissection Impairment Index

时间窗: At baseline

It consists of 10 items. Scoring is done according to the 5-point Likert scale. The patients answer the questions in the index as "1 = Not at all, 2 = A little, 3 = A moderate amount, 4 = Quite a bit, 5 = A lot". In order to standardize the obtained raw score over 100 points, the formula "(raw score-10) / 40\] × 100" is used. This index evaluates the quality of life associated with neck and shoulder problems that occur in the long term after neck dissection \[6\].

次要结局

  • Modified Constant-Murley Score(At baseline)
  • Short Form-36 Health Survey version-2.0(At baseline)

研究者

发起方
Izmir Bakircay University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kadirhan Ozdemir, PT, PhD.

Head of Geriatric Rehabilitation Department

Izmir Bakircay University

研究点 (1)

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