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

NCT06239779 | Completed

• 1 other identifier: Antalya AtatürkStateHospital
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Pain Syndrome; Addiction, Mobile Phone

Keywords

fibromyalgia; education; pain; phone addiction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Exercise Frequency

  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

  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.

Study Arms (2)

Education Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

Education OTHER

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.

Education Group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

Ataturk State Hospital

Antalya, 07040, Turkey (Türkiye)

Location

Related 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.

  PMID: 30453109 BACKGROUND

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

  PMID: 36791450 BACKGROUND

• 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.

  PMID: 37744504 BACKGROUND

• 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.

  PMID: 34425915 BACKGROUND

MeSH Terms

Conditions

Fibromyalgia; Somatoform Disorders; Technology Addiction; Pain

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Mental Disorders; Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Nazlı Ölçücü, MD

  Physical Medicine and Rehabilitation specialist

  STUDY DIRECTOR

• Selkin Yılmaz Muluk, MD

  Antalya Ataturk State Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: In this study, both participant and investigator masking will be implemented to minimize potential bias and maintain objectivity. Participants in the education group will be unaware of the existence of the control group, and conversely, participants in the control group will be unaware of the education group. Additionally, to further ensure objectivity, after data collection, a secretary will anonymize patients into groups A and B using stickers. This comprehensive masking approach will prevent both participants and the investigator from being influenced by knowledge of group assignments during data analysis and interpretation, thereby enhancing research integrity.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Physical Therapy and Rehabilitation specialist

Model Details: This study is a randomized controlled trial with a pre-post intervention (education) evaluation.

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 2, 2024
• Study Start: January 19, 2024
• Primary Completion: June 19, 2024
• Study Completion: June 24, 2024
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Sharing will occur from the date of publication and continue for a period of three months thereafter.
• 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.

Locations

TU (1)