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临床试验/NCT07174635
NCT07174635已完成不适用

The Effect of Tele-Nursing Service on Patients' Pain and Activity Level in Patients Diagnosed With Fibromyalgia

Çankırı Karatekin University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2024年4月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
1
主要终点
Change in pain severity as measured by the Short Form McGill Pain Questionnaire (SF-MPQ) sensory subscale at 2 months

研究概览

简要总结

The aim of the study was to determine the effect of tele-nursing service provided to patients diagnosed with fibromyalgia on the pain and activity level of patients. The study was designed as a randomised controlled experimental study in a pretest-posttest design. The research was conducted in a State Hospital between April 2024 and June 2024 with patients diagnosed with fibromyalgia who applied to the physical therapy outpatient clinic and met the inclusion criteria. The sample was divided into two groups as intervention and control groups of 22 participants by simple randomisation. Descriptive Information Form, Fibromyalgia Impact Questionnaire Revised (FIQR), Mcgill Pain Scale were used as data collection tools in the study. The second researcher was given the contact information of all patients and the data collection forms were applied as a pre-test. The second researcher did not know which group the patients were in. Thus, the researcher collecting the data was blinded. Data collection forms were administered by the researcher by interviewing the patient in approximately 15-20 minutes. Patients in the intervention group were called three times by phone and were trained in accordance with the prepared training booklet by first researcher.

详细描述

Fibromyalgia is a chronic condition of unknown etiology, characterized by widespread musculoskeletal pain, sleep disturbances, fatigue, anxiety, and impaired cognitive functions.Fibromyalgia-related pain often increases during or after physical activity and may interfere with patients' ability to perform daily living activities. Despite extensive research, the exact cause of the disease remains unknown.

This study aimed to evaluate the effectiveness of nurse-led telephone counseling on pain severity and physical activity levels in patients who met the inclusion criteria. A total of 44 participants were enrolled: 22 in the intervention group (who received telephone-based counseling and education from a nurse) and 22 in the control group (who received no intervention).

All participants were informed about the study, and written informed consent was obtained. At baseline, all patients completed pre-test questionnaires. The intervention group received additional follow-up through two telephone calls during the intervention period.

The nurse provided education and counseling on various topics, including pain management strategies, ways to increase physical activity, appropriate exercise, and stress coping techniques. Non-pharmacological treatment options for pain relief were also discussed. The educational intervention lasted approximately 4 weeks.

Following the completion of the intervention, post-tests were administered to all participants. Two months after the intervention, the FIQR (Fibromyalgia Impact Questionnaire-Revised),and the McGill Pain Questionnaire were completed by all patients to assess outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • •Individuals diagnosed with fibromyalgia
  • •Aged 18 years or older
  • •No communication impairments that would hinder participation in the study or the ability to receive education (e.g., hearing loss, visual impairment, or difficulty understanding/speaking Turkish)
  • •Reachable by phone
  • •Willing to participate voluntarily.

排除标准

  • •People with communication problems
  • •People with hearing and/or speech problems
  • •Can't speak Turkish,

研究组 & 干预措施

Intervention-telenursing

Experimental

The second researcher did not know which group the patients were in. Thus, both the patient and the researcher who collected the data were blinded. the data collection forms were applied as a pre-test by second researcher. The first researcher sent an educational booklet prepared on the educational topics or the topics the patient needed to the patients in the experimental group as a message. The patient was then called by phone and informed about the educational booklet. After the main interview, the patients were called 2 more times for follow-up. The intervention group was given education on topics such as reducing pain complaints, increasing activity level, exercise, and coping with stress. The education of the intervention group lasted approximately 4 weeks. After the completion of the training of the intervention group, the second researcher applied the post-tests to all patients. The FIQR, VAS, and Mcgill pain scale were filled out as the post-tests.

干预措施: Intervention-telenursing (Behavioral)

Controll

No Intervention

The second researcher did not know which group the patients were in. Thus, both the patient and the researcher who collected the data were blinded. The second researcher was given the contact information of all patients and the data collection forms were applied as a pre-test.After the completion of the training of the intervention group, the second researcher applied the post-tests to all patients. The FIQR, VAS, and Mcgill pain scale were filled out as the post-tests. Participants in this group did not receive any counseling or educational intervention. They completed pre- and post-tests during the same period as the intervention group but received standard care only.

结局指标

主要结局

Change in pain severity as measured by the Short Form McGill Pain Questionnaire (SF-MPQ) sensory subscale at 2 months

时间窗: At the beginning and at week 8

The Short Form McGill Pain Questionnaire (SF-MPQ) is a widely used tool for assessing the qualitative and quantitative aspects of pain.The SF-MPQ consists of three main components: 1-Pain Rating Index (PRI) - Divided into: Sensory subscale: 11 descriptors (e.g., throbbing, shooting, stabbing) Affective subscale: 4 descriptors (e.g., tiring, fearful, punishing) Each descriptor is rated on a 4-point scale:0 = None,1 = Mild,2 = Moderate,3 = Severe. A 6-point ordinal scale where the participant selects one of the following to describe their current pain: 0 = No pain 1. = Mild 2. = Discomforting 3. = Distressing 4. = Horrible 5. = Excruciating Higher scores indicate more severe pain.SF-MPQ was administered at baseline and at 2 months post-intervention.

次要结局

  • Change in health status as measured by Revised Fibromyalgia Impact Questionnaire (FIQR) at 2 months(At the beginning and at week 8)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nedret Tekin Kaya

Assist Prof.

Çankırı Karatekin University

研究点 (1)

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