Effects of Fibromyalgia Education on Smart Phone Addiction, Pain, and Quality of Life

Quality of Life Clinical Trial

— EFESAPQL  

Official title:

Effects of Fibromyalgia Education on Smart Phone Addiction, Pain, and Quality of Life in Fibromyalgia Patients: A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06239779
• Other study ID #: Antalya AtatürkStateHospital
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2024
• Est. completion date: June 24, 2024

Study information

• Verified date: June 2024
• Source: Antalya Training and Research Hospital
• Contact: Nazli Ölçücü, MD
• Phone: +905314905109
• Email: sennazl[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 improvements in their quality of life and smart phone addiction after receiving fibromyalgia education.

Participants will report their recent exercise, social activities, sleep quality, 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, socialization, sleep, 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 a brief 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, quality of life, smart phone addiction, socialization, exercise, sleep, and screen time based on patient diaries. The results will deepen our understanding of how brief education can enhance the lives of fibromyalgia patients and aid in developing more effective strategies to manage pain and improve their quality of life.

Description:

Fibromyalgia is a rheumatological 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, quality of life and smart phone addiction after receiving fibromyalgia education.

On the first day, all participants will be asked about their recent exercise duration, social activities, sleep quality, 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, socialization, sleep, 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, socialization, sleep management, cognitive behavioral therapy, 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 10-minute 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, quality of life, smart phone addiction (measured by FIQR and SAS-SV), socialization frequency, exercise frequency, sleep quality, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: June 24, 2024
• Est. primary completion date: June 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Behavior, Addictive
• Fibromyalgia
• Myofascial Pain Syndromes
• Pain Syndrome
• Quality of Life
• Technology Addiction

Intervention

Other:
• Education
The education intervention involves a brief PowerPoint presentation delivered by a physician, covering an overview of fibromyalgia, coping strategies, and the potential impact of smart phone addiction on fibromyalgia.

Locations

Country	Name	City	State
Turkey	Ataturk State Hospital	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View 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. — View 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. — View Citation

Winslow BT, Vandal C, Dang L. Fibromyalgia: Diagnosis and Management. Am Fam Physician. 2023 Feb;107(2):137-144. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Levels, Quality of Life, and Physical Function	These are measured using the Fibromyalgia Impact Questionnaire - Revised Form is a widely recognized instrument for assessing the impact of fibromyalgia on patients' lives. FIQR encompasses various dimensions, including pain levels, quality of life, and physical function. It employs a scale with a minimum value of 0, a maximum value of 100, and higher scores indicating worse outcome fibromyalgia impact. The study aims to assess the impact of fibromyalgia education on pain levels, quality of life, and physical function using this questionnaire.	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.
Primary	Smart Phone Addiction	This is measured using the Smartphone Addiction Scale-short version. The study aims to assess the impact of fibromyalgia education on smart phone addiction using this scale.	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	Exercise Frequency	This outcome is evaluated based on participant diaries. The study intends to determine how fibromyalgia education may affect participants' exercise habits.	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.
Secondary	Socialization Frequency	This outcome is evaluated based on participant diaries. The study intends to determine how fibromyalgia education may affect participants' socialization.	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.
Secondary	Sleep Quality	This outcomes is evaluated based on participant diaries. The study intends to determine how fibromyalgia education may affect participants' sleep quality.	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.
Secondary	Daily Screen Time	This outcome is evaluated based on participant diaries. The study intends to determine how fibromyalgia education may affect participants' daily screen time on smart phone.	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.