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

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

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia; Pain Syndrome; Addiction, Mobile Phone
• Intervention / Treatment: Other: Education

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey, 07040
    • Ataturk State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Education Group; The Education Group will be comprised of study participants who will receive an educational intervention aimed at enhancing their understanding and management of fibromyalgia. This group is designed to assess the impact of fibromyalgia education on various aspects of participants' well-being, including pain levels, smart phone addiction, and daily activities. Participants in the Education Group will attend an educational session. The educational content will cover the following key topics: an overview of fibromyalgia, coping strategies and potential harmful effects of smart phone addiction on fibromyalgia. The primary objective of the Education Group is to evaluate the influence of fibromyalgia education on pain levels, quality of life and physical function (measured using the FIQR) and smart phone addiction (measured using the SAS-SV), exercise frequency and daily screen time based on participant diaries.	Other: Education; The education intervention will involve a PowerPoint presentation delivered individually by a physician to each participant in intervention group, covering an overview of fibromyalgia, coping strategies, and the potential impact of smart phone addiction on fibromyalgia.
No Intervention: Control Group; The Control Group is a vital component of this study, serving as a reference group for evaluating the impact of the Education Group's intervention. Participants in this group will not receive the structured educational intervention. Instead they will follow their usual routines and receive standard care for fibromyalgia, which may include any recommendations typically offered by their healthcare providers but they are monitored similarly to the participants in the Education Group. The primary objective of the Control Group is to provide a baseline against which the effects of the educational intervention received by the Education Group can be compared. By not receiving the intervention, this group will help assess whether the educational program has a measurable impact on various aspects of participants' well-being when compared to standard care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Daily Screen Time	This outcome is evaluated based on participants' self-reported daily screen time, retrieved from the settings of their smartphones and recorded in their 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.

Collaborators and Investigators

• Sponsor: Antalya Training and Research Hospital
• Investigators: Study Director: Nazlı Ölçücü, MD, Physical Medicine and Rehabilitation specialist; Principal Investigator: Selkin Yılmaz Muluk, MD, Antalya Ataturk State Hospital

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2024
• Primary Completion (Actual): June 19, 2024
• Study Completion (Actual): June 24, 2024

Study Registration Dates

• First Submitted: January 26, 2024
• First Submitted That Met QC Criteria: January 26, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: pain; fibromyalgia; education; phone addiction
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Compulsive Behavior; Impulsive Behavior; Internet Addiction Disorder; Technology Addiction; Fibromyalgia; Myofascial Pain Syndromes; Behavior, Addictive
• Other Study ID Numbers: Antalya AtatürkStateHospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators do not plan to share questionnaires, scales, or patient diaries as they include personal data but are open to sharing the results of the data and the statistic analysis details upon reasonable request,
• IPD Sharing Time Frame: Sharing will occur from the date of publication and continue for a period of three months thereafter.
• IPD Sharing Access Criteria: Access will be granted to researchers, institutions, or organizations with a legitimate research purpose directly related to the subject matter of the shared data. All parties seeking access must sign an agreement confirming their commitment to maintaining the confidentiality of the data and using it only for research purposes.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No