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临床试验/NCT05893290
NCT05893290已完成不适用

How Does Basic Body Awareness Therapy Effect Pain Coping Strategies in Postmenopausal Women? a Randomized Controlled Study

European University of Lefke2 个研究点 分布在 2 个国家目标入组 54 人开始时间: 2023年5月31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
54
试验地点
2
主要终点
Oswestry Low Back Pain Disability Index

研究概览

简要总结

Exercise interventions are deemed essential for the effective management of patients with pain. Various therapy methods have been shown in the literature for pain and coping with pain. However, there is no study investigating the effectiveness of Basic Body Awareness Therapy in pain and coping with pain. In this respect, our study will contribute to the literature. The aim of our study is to compare the effectiveness of Basic Body Awareness Therapy and Therapeutic Exercises on pain coping strategies of Postmenopausal women.

详细描述

The patients will be randomly assigned into three groups: Therapeutic Exercise (TE) Group, Therapeutic Exercise+Basic Body Awareness (TE+BBAT) Group, and Control Group. Each group will be treated for 12 weeks. Individuals will be evaluated in detail at the beginning and end of the study. The follow-up assessments of the study will be done 3 months after the conclusion of the treatments. Physical and sociodemographic characteristics will be evaluated by dedicated form. The body awareness of the participants will be evaluated Body Awareness Questionnaire (BAQ) developed by Shields, Mallory & Simon in 1989. The pain levels of the PmW will be measured with the Short Form McGill Pain Questionnaire. Pain coping strategies of PmW will be assessed with Pain Coping Inventory (PCI). The Oswestry Low Back Pain Disability Index will be used for evaluating the disability level caused by low back pain. The Neck Disability Index will be used for evaluating the disability level caused by neck pain.

研究设计

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

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Participants should have;
  • Chronic lower back or neck pain lasting at least six months
  • Gone through the menopausal transition naturally within the last year
  • Not received a physiotherapy approach for pain management in the last six months
  • Be able to read and write in Turkish.

排除标准

  • Presence of significant neurological disorders
  • Presence of serious mental and psychological disorder

结局指标

主要结局

Oswestry Low Back Pain Disability Index

时间窗: 5 minutes

The Oswestry low back pain disability index (OLBPDI), first published in 1980, was developed to assess pain-related disability in people with acute, subacute, or chronic low back pain. It includes 1 item related to pain and 9 items related to activities of daily living (personal care, lifting, walking, sitting, standing, sleeping, social life and travel). Each item is measured on a 6-point ranking scale from best to worst-case scenario. A total score of 0-4 indicates no disability, 5-14 indicates mild disability, 15-24 indicates moderate disability, 25-34 indicates severe functional disability, and 35-50 indicates full functional disability.

McGill-Short Form Pain Questionnaire

时间窗: 5 minutes

The pain levels of the PmW will be measured with the Short Form McGill Pain Questionnaire. The questionnaire, developed by Melzack in 1987 and the validity and reliability of the Turkish version of which was demonstrated in 2007, is widely used in measuring pain. This questionnaire consists of a total of 15 descriptive words to determine the sensory (11 words) and affective (4 words) dimensions of pain. In this section, the severity of pain (0=absent, 1=mild, 2=moderate, 3=severe) is evaluated. In addition, the pain felt at the time of measurement is measured with the Visual Analogue Scale (VAS) and the total pain intensity is measured with a 10-point Likert scale. On this scale, 1 = no pain, 10 = unbearable pain.

Pain Coping Strategies

时间窗: 5 minutes

Pain coping strategies of PmW will be assessed with Pain Coping Inventory (PCI). The scale developed by Kraaimaat and Evers evaluates how often chronic pain patients use behavioral and cognitive methods to cope with pain. The original form of the scale includes six dimensions as pain transformation, distraction, reducing demands, retreating, worrying, and resting. Pain transformation, comforting thinking, and distraction are active coping methods; retreat, worrying, and resting are passive coping methods. The scoring options range from 1 (almost none) to 4 (very often).

Neck Disability Index

时间窗: 5 minutes

The questionnaire, which evaluates subjective symptoms and activities of daily living, consists of 10 sections (pain severity, lifting weights, sleep, reading, driving, headache, concentration, work life, personal care, and leisure activities). For each section, there are 6 items ranging from 0-5 points. The total score ranges from 0 to 50 (0: no excuse; 50: maximum excuse). The total score obtained from the questionnaire expresses the severity of neck disability (0-4 points no disability, 5-14 points mild disability, 15-24 points moderate disability, 25-34 points severe disability, and over 35 points total disability).

Body Awareness Questionnaire (BAQ)

时间窗: 3 minutes

Body awareness of the participants will be evaluated Body Awareness Questionnaire (BAQ) developed by Shields, Mallory \& Simon. BAQ is a questionnaire that aims to determine the normal or abnormal sensitivity level of body composition. It consists of four subgroups (Attention to changes in body process and responses, sleep-wake cycle, prediction at onset of illness, prediction of body responses) and a total of 18 statements. The participant will be asked to rate each statement with numbers from one to seven (1 = not at all true for me, 7 = completely true for me). Rating in the survey is done as a total score. It is concluded that the higher the total score to be obtained from the questionnaire, the better the body awareness.

次要结局

未报告次要终点

研究者

发起方
European University of Lefke
申办方类型
Other
责任方
Sponsor

研究点 (2)

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