Improving quality of life for a patient with fibromyalgia and their caregiver: A protocol for the application of the integrative medical service model

Not Applicable

Completed

• Conditions: Diseases of the musculoskeletal system and connective tissue

• Registration Number: KCT0007626
• Lead Sponsor: Wonkwang University. Iksan Korean Medicine Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-11-01
• Last Update Posted: 10 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

A. Patient
1. Adult men and women aged between 20 and 65
2. Adult men and women aged between 20 and 65 who have been clinically diagnosed with fibromyalgia by a specialistBased on the 2016 WPI of the American Society of Rheumatology, 7 points or more, 5 points or more, and chronic pain lasts at least 3 months
3. Based on the 2016 Rheumatoid Society WPI, between 3 and 6 points, severe severity is 9 points or higher, and chronic pain lasts at least 3 months
4. Those who can read and respond to the questionnaire
5. A person who understands the purpose of this study and agrees in writing to participate in the study;

B. his/her caregiverAn adult (aged between 20 and 65) guardian of the selected patient who voluntarily agreed to participate in this study (the guardian is a trusted adult who takes care of his family or daily life)

Exclusion Criteria

1. A person with a history of major psychiatric disorders such as schizophrenia spectrum disorder, delusion disorder, bipolar disorder, alcohol or substance abuse disorder diagnosed by DSM-5
2. Persons with chronic diseases that may affect the results of the study
3. Those who have participated in other clinical studies within the last month;
4. Those who are unable to communicate normally due to dementia or mild cognitive impairment;
5. Patients with somatform disorder whose main complaint is pain, but whose physical cause is not clear, and whose mental problems are significant
6. Those who are unable to communicate and have restrictions on reading and writing questionnaires
7. Any other person who determines that the study will not be conducted according to the patient's medical condition;

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
EQ-5D-5L, EQ-VAS

Secondary Outcome Measures

Name	Time	Method
Severity (SSS), Pain (WPI), Daily Activity Disorder Measurement, Number Pain Rating Scale (NPRS), Core Emotional Accuracy Scale (CSEI-S), Sleep Quality Index, and Mind Room Drawing