Clinical trial NCT06239779: Effects of Fibromyalgia Education on Smart Phone Addiction, Pain, and Quality of Life
Official title: Effects of Fibromyalgia Education on Smart Phone Addiction, Pain, and Quality of Life in Fibromyalgia Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Pain Syndrome
Addiction, Mobile Phone
Keywords: fibromyalgia
education
pain
phone addiction
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-02-02
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized controlled trial with a pre-post intervention (education) evaluation.
Primary purpose: OTHER

Brief summary: The study focuses on fibromyalgia, a condition characterized by chronic pain, fatigue, and associated issues like sleep disorders, depression, and anxiety. The investigators' goal is to detect smart phone addiction among fibromyalgia patients and assess potential decreases in pain and smart phone addiction after receiving fibromyalgia education.

Participants will report their recent exercise and screen time for the past week. They will also complete the Revised Fibromyalgia Impact Questionnaire (FIQR) to measure pain and physical function and the Smart Phone Addiction Scale-Short Version (SAS-SV) to assess smart phone use. Diaries will track daily exercise and screen time for 20 days.

The intervention group will receive fibromyalgia education, covering an overview of fibromyalgia, coping strategies, and discussions on the impact of digital addictions. This education, delivered via Microsoft PowerPoint program presentation by a physician, aims to help patients.

After 20 days, all participants will redo the FIQR and SAS-SV assessments, and diary data will be collected.

This study examines how physician-provided fibromyalgia education affects pain levels, smart phone addiction, exercise and screen times. The results will deepen our understanding of how education can enhance the lives of fibromyalgia patients and aid in developing more effective strategies to manage pain and improve their quality of life.

Detailed description: Fibromyalgia is a musculoskeletal disease characterized by chronic pain, fatigue, and often accompanied by sleep disorders, depression, and anxiety. This study aims to identify smart phone addiction among fibromyalgia patients and explore potential improvements in their pain and smart phone addiction after receiving fibromyalgia education.

On the first day, all participants will be asked about their recent exercise duration and average screen time over the past week. They will then complete the FIQR to assess pain, quality of life and physical function in fibromyalgia, as well as the SAS-SV to measure smart phone use. Participants will receive their SAS-SV scores and be provided with diaries to record daily exercise and smart phone screen time for the next 20 days.

Patients in the intervention group will receive fibromyalgia education, which includes an overview of fibromyalgia, coping strategies (exercise, sleep management, stress reduction), and discussions on the impact of digital addictions like smart phone addiction on quality of life and stress levels. This education, presented as a face-to-face individual based Microsoft PowerPoint slide show, will be delivered by the researcher physician.

At the 20th-day follow-up, all participants will again complete the FIQR questionnaire and SAS-SV scale, and data from their diaries will be collected for further analysis.

This study aims to assess how fibromyalgia education provided by a physician affects pain levels, smart phone addiction (measured by FIQR and SAS-SV), exercise frequency, and daily screen time based on patient diaries. The findings will contribute to our understanding of how brief fibromyalgia education may impact the daily lives of patients and help develop more effective strategies to alleviate pain and enhance the quality of life for individuals with fibromyalgia.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Fibromyalgia: Participants must have received a definitive diagnosis of fibromyalgia from a specialist. This diagnosis should have been made within the last 6 -months or they should be newly diagnosed with fibromyalgia.
* Ownership of a Smart Phone: Participants are required to own a smart phone as this is essential for aspects of the research related to smart phone addiction.
* Ability to Collaborate: Participants must be willing to actively participate in the research process, follow data collection procedures, and collaborate with the research team.

Exclusion Criteria:

* Cognitive Impairment or Severe Neurological/Psychiatric Illness: Individuals with significant cognitive impairment or severe neurological or psychiatric conditions that may affect their participation are excluded.
* Serious Health Conditions: Individuals with severe health conditions (e.g., cancer, chronic heart disease) that substantially affect their daily life and could confound the study outcomes are excluded.
* Other Addictions: Individuals with other types of addictions (e.g., alcohol, substance addiction) are not eligible for participation.
* Recent Serious Surgery or Trauma: Individuals who have undergone major surgery or experienced significant trauma recently are excluded.
* Unwillingness to Participate: Individuals who are unwilling to participate in the research process or who do not consent to be part of the study are excluded.
* Non-Compliance with Procedures: Individuals who are unable or unwilling to comply with data collection procedures as outlined by the research team are excluded.

Primary outcomes:
measure: Pain Levels, Quality of Life, and Physical Function
timeFrame: This assessment is conducted at the beginning of the study (first day) and at the end of the study (20th day). Therefore, the time frame for this assessment spans from the first day to the 20th day of the study.
measure: Smart Phone Addiction
timeFrame: This assessment is conducted at the beginning of the study (first day) and at the end of the study (20th day). Therefore, the time frame for this assessment spans from the first day to the 20th day of the study
Secondary outcomes:
measure: Exercise Frequency
timeFrame: Participants start filling out the diary on the first day of the study and continue to do so every day for the entire 20-day duration of the study. The time frame for the diary entries covers the entire 20-day period.
measure: Daily Screen Time
timeFrame: Participants start filling out the diary on the first day of the study and continue to do so every day for the entire 20-day duration of the study. The time frame for the diary entries covers the entire 20-day period.
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Ataturk State Hospital
Study officials:
affiliation: Physical Medicine and Rehabilitation specialist
name: Nazlı Ölçücü, MD
role: STUDY_DIRECTOR
affiliation: Antalya Ataturk State Hospital
name: Selkin Yılmaz Muluk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arnold LM, Bennett RM, Crofford LJ, Dean LE, Clauw DJ, Goldenberg DL, Fitzcharles MA, Paiva ES, Staud R, Sarzi-Puttini P, Buskila D, Macfarlane GJ. AAPT Diagnostic Criteria for Fibromyalgia. J Pain. 2019 Jun;20(6):611-628. doi: 10.1016/j.jpain.2018.10.008. Epub 2018 Nov 16.
citation: Winslow BT, Vandal C, Dang L. Fibromyalgia: Diagnosis and Management. Am Fam Physician. 2023 Feb;107(2):137-144.
citation: Nikolic A, Bukurov B, Kocic I, Vukovic M, Ladjevic N, Vrhovac M, Pavlovic Z, Grujicic J, Kisic D, Sipetic S. Smartphone addiction, sleep quality, depression, anxiety, and stress among medical students. Front Public Health. 2023 Sep 6;11:1252371. doi: 10.3389/fpubh.2023.1252371. eCollection 2023.
citation: Kulekcioglu S, Cetin A. Social media use in patients with fibromyalgia and its effect on symptom severity and sleep quality. Adv Rheumatol. 2021 Aug 23;61(1):51. doi: 10.1186/s42358-021-00210-7.