跳至主要内容
临床试验/NCT05821036
NCT05821036进行中(未招募)不适用

Examining the Effects of Activity Management in Women With Fibromyalgia Syndrome :Randomized Controlled Study

Ankara Medipol University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年6月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
30
试验地点
1
主要终点
Canadian Occupational Performance Measurement (COPM)

研究概览

简要总结

Purpose: To determine the effects of activity management training on pain, occupational performance, quality of life, depression, anxiety and occupational balance in women with fibromyalgia syndrome (FMS).

In addition to, reducing pain, which is the main symptom of FMS, by regulating the activity-rest cycle, it is aimed to increase people's participation in daily life and improve their quality of life.

Method: A randomized controlled trial. A total of 10 sessions of individual-internet-based activity management training are applied to women with FMS in the intervention group, 2 sessions a week for 5 weeks, 1st and 10th sessions are pre- and post-training evaluation. Assessments before and after training The Revised Fibromyalgia Impact Questionnaire (FIQR), Canadian Occupational Performance Measure(COPM), Pain-activity patterns scale (Pomp/APPS) ,Nottingham Health Profile,The hospital anxiety and depression scale,The Occupational Balance Questionnaire (OBQ) is applied.Although no intervention is applied to the control group, only preliminary and final evaluations are completed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Having been diagnosed with FMS by a specialist physician,
  • •Being a woman between the ages of 18-64,
  • •To be literate,
  • •Having and actively using a smartphone or a computer

排除标准

  • •Any disease accompanying FMS, the presence of psychiatric illness and endocrine disorders,
  • •Have previous activity management training,
  • •Currently and up to 4 weeks on psychotropic medication,
  • •Breastfeeding and pregnancy

研究组 & 干预措施

Intervention group

Experimental

Inclusion criteria:

  • Having been diagnosed with FMS by a specialist physician,
  • Being a woman between the ages of 18-64,
  • To be literate,
  • Having and actively using a smartphone or a computer

Exclusion criteria:

  • Any disease accompanying FMS, the presence of psychiatric illness and endocrine disorders,
  • Have previous activity management training,
  • Currently and up to 4 weeks on psychotropic medication,
  • Breastfeeding and pregnancy

干预措施: Activitiy Management (Behavioral)

Control group

No Intervention

Inclusion criteria:

  • Having been diagnosed with FMS by a specialist physician,
  • Being a woman between the ages of 18-64,
  • To be literate,
  • Having and actively using a smartphone or a computer

Exclusion criteria:

  • Any disease accompanying FMS, the presence of psychiatric illness and endocrine disorders,
  • Have previous activity management training,
  • Currently and up to 4 weeks on psychotropic medication,
  • Breastfeeding and pregnancy

结局指标

主要结局

Canadian Occupational Performance Measurement (COPM)

时间窗: 20 minute

It focuses on ocuopational performance in all areas of life, including self-care, leisure, and productivity. It is a person-centered scale created for individuals to analyze and prioritize the factors that limit their participation in ADLs. Turkish cultural adaptation, validity and reliability 2017 (Cronbach Alpha internal consistency coefficient 0.9-1.)

The Revised Fibromyalgia Impact Questionnaire (FIQ/RFEA)

时间窗: 15 minute

It is a questionnaire that evaluates the limitations and functional impairment in patients with fibromyalgia with a total of 21 questions in three sections: function, general and symptoms. All questions are evaluated on a numerical scale between 0-10. The higher the score obtained from the questionnaire, the higher the disability due to fibromyalgia. Turkish validity and reliability was performed by Ediz et al. on female patients with fibromyalgia. (Cronbach's alpha value is 0.89 for FIQR 1st visit (first assessment) and 0.91 for FIQR 2nd visit (second assessment).)

Ocupational Balance Questionnaire (OB-Quest)

时间窗: 15 minute

Occupational balance, which is considered to be an important component of health and well-being, is a very important concept in occupational therapy.The concept of 'ocupational balance' is the right amount of the perception that it has the oculation and that it has the right variety between ocuations.Opations and roles in the life cycle, personal factors and ıt has a dynamic structure that changes with external factors. There is a constant transition between ocupational imbalance and balance.The Ocupational Balance Questionnaire (OB-Task) is designed as a standard tool to assess a person's ocupational balance. The questionnaire consists of 10 closed-ended questions. The Turkish validity and reliability were evaluated by Bahadır et al. in 2021. The alpha score of the Turkish OB-Quest Cronbach is 0.645 and it has questionable internal consistency.

Patterns of Activity Measure" (POAM-P)

时间窗: 15 minute

It analyzes the altered activity patterns of individuals with chronic pain while creating their activities. The questionnaire consists of 30 questions and all questions are evaluated on a numerical scale between 0-4. Its Turkish adaptation, validity and reliability were performed by Emine Tunç Süygün on patients with chronic low back/neck pain in 2019. (Cronbach's alpha coefficient is 0.941 for avoidance, 0.917 for overdoing, and 0.940 for regulation.)

Nottingham Health Profile (NSP)

时间窗: 15 minute

It consists of 38 questions examining the effects of health problems on different areas of quality of life and 6 sections including physical activity, pain, sleep, social isolation, emotional reactions and energy level. These parameters are; pain (8 items), physical activity (8 items), energy (3 items), sleep (5 items), social isolation (5 items), emotional reactions (9 items). Each sub-parameter is scored between 0-100. 0 indicates best health, 100 indicates worst health. Turkish validity and reliability of the questionnaire Küçükdeveci, McKenna, Kutlay et al. (2002) by

Hospital anxiety depression scale (HADS)

时间窗: 15 minute

Hospital anxiety depression scale (HADS) was developed by Zigmoid and Snaith to examine anxiety and depression in individuals with physical illness. 7 questions of the 14-item scale question anxiety and 7 questions about depression symptoms. assessed on a four-point Likert scale. The answers given to the questions are scored between 0-3. The sum of the scores of the odd questions gives the anxiety subscale (HAD-A) score, and the sum of the scores of the even questions gives the depression subscale (HAD-D) score. The lowest score that patients can get from both subscales is 0, and the highest score is 21. The Turkish validity and reliability study of the scale was performed by Aydemir in 1997. (Cronbach's alpha coefficient 0.8525 for anxiety, 0.7784 for depression)

次要结局

未报告次要终点

研究者

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

Sena Albay

Research Assistant

Ankara Medipol University

研究点 (1)

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