## Protocol Section
### Identification Module
**NCT ID:** NCT06239779

**Acronym:** EFESAPQL

**Brief Title:** 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

#### Organization Study ID Info
**ID:** Antalya AtatürkStateHospital
#### Organization
**Class:** OTHER_GOV
**Full Name:** Antalya Training and Research Hospital
### Status Module
#### Completion Date
**Date:** 2024-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-07

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-06

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-04

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-19

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2024-02-02
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-26
**Study First Submit QC Date:** 2024-01-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Antalya Training and Research Hospital

#### Responsible Party

**Investigator Affiliation:** Antalya Training and Research Hospital

**Investigator Full Name:** Selkin Yılmaz Muluk

**Investigator Title:** MD, Physical Therapy and Rehabilitation specialist

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 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.

**Detailed 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.

### Conditions Module

**Conditions:**

- Fibromyalgia

- Pain Syndrome

- Quality of Life

- Addiction, Mobile Phone

**Keywords:**

- fibromyalgia

- education

- pain

- quality of life

- phone addiction

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

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

##### Masking Info

**Masking:** DOUBLE

**Masking Description:** In this study, both participant and investigator masking have been implemented to minimize potential bias and maintain objectivity. Participants in the education group are unaware of the existence of the control group, and conversely, participants in the control group are unaware of the education group. Additionally, to further ensure objectivity, after data collection, a secretary anonymizes patients into groups A and B using stickers. This comprehensive masking approach prevents both participants and the investigator from being influenced by knowledge of group assignments during data analysis and interpretation, thereby enhancing research integrity.

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 112

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The Education Group is comprised of study participants who 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, quality of life, smart phone addiction, and daily activities.

Participants in the Education Group will attend a brief educational session. The educational content covers 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) and socialization frequency, exercise frequency, sleep quality and daily screen time based on participant diaries.

**Intervention Names:**

- Other: Education

**Label:** Education Group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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 do not receive the structured educational intervention. Instead they 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 helps assess whether the educational program has a measurable impact on various aspects of participants' well-being when compared to standard care.

**Label:** Control Group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Education Group

**Description:** 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.

**Name:** Education

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Pain Levels, Quality of Life, and Physical Function

**Time Frame:** 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.

**Description:** 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.

**Measure:** Smart Phone Addiction

**Time Frame:** 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

**Description:** This outcome is evaluated based on participant diaries. The study intends to determine how fibromyalgia education may affect participants' exercise habits.

**Measure:** Exercise Frequency

**Time Frame:** 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.

**Description:** This outcome is evaluated based on participant diaries. The study intends to determine how fibromyalgia education may affect participants' socialization.

**Measure:** Socialization Frequency

**Time Frame:** 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.

**Description:** This outcomes is evaluated based on participant diaries. The study intends to determine how fibromyalgia education may affect participants' sleep quality.

**Measure:** Sleep Quality

**Time Frame:** 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.

**Description:** 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.

**Measure:** Daily Screen Time

**Time Frame:** 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.

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 20 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** sennazl@hotmail.com

**Name:** Nazlı Ölçücü, MD

**Phone:** +905314905109

**Role:** CONTACT

**Contact 2:**

**Email:** selkin.yilmazmuluk@saglik.gov.tr, selkinylmaz@yahoo.com

**Name:** Selkin Yılmaz Muluk, MD

**Phone:** +905321304062

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Antalya

**Contacts:**

***Contact 1:***

- **Email:** sennazl@hotmail.com

- **Name:** Nazlı Ölçücü

- **Phone:** +905314905109

- **Role:** CONTACT

***Contact 2:***

- **Email:** selkin.yilmazmuluk@saglik.gov.tr, selkinylmaz@yahoo.com

- **Name:** Selkin Yılmaz Muluk

- **Phone:** +905321304062

- **Role:** CONTACT

**Country:** Turkey

**Facility:** Ataturk State Hospital

**Status:** RECRUITING

**Zip:** 07040

#### Overall Officials

**Official 1:**

**Affiliation:** Physical Medicine and Rehabilitation specialist

**Name:** Nazlı Ölçücü, MD

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Antalya Ataturk State Hospital

**Name:** Selkin Yılmaz Muluk, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**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.

**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,

**Info Types:**

- STUDY_PROTOCOL

- ICF

- CSR

**IPD Sharing:** YES

**Time Frame:** Sharing will occur from the date of publication and continue for a period of three months thereafter.

### References Module

#### 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.

**PMID:** 30453109

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

**PMID:** 36791450

**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.

**PMID:** 37744504

**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.

**PMID:** 34425915

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009135

- Term: Muscular Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

- ID: D000009468

- Term: Neuromuscular Diseases

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000003192

- Term: Compulsive Behavior

- ID: D000007175

- Term: Impulsive Behavior

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M8486

- Name: Fibromyalgia

- Relevance: HIGH

- As Found: Fibromyalgia

- ID: M12161

- Name: Myofascial Pain Syndromes

- Relevance: HIGH

- As Found: Fibromyalgia

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M19100

- Name: Behavior, Addictive

- Relevance: HIGH

- As Found: Addiction

- ID: M2355

- Name: Internet Addiction Disorder

- Relevance: HIGH

- As Found: Smart Phone Addiction

- ID: M2684

- Name: Technology Addiction

- Relevance: HIGH

- As Found: Addiction, Mobile Phone

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12411

- Name: Neuromuscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6418

- Name: Compulsive Behavior

- Relevance: LOW

- As Found: Unknown

- ID: M10220

- Name: Impulsive Behavior

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: HIGH

- As Found: Quality of Life

### Condition Browse Module - Meshes

- ID: D000005356

- Term: Fibromyalgia

- ID: D000009209

- Term: Myofascial Pain Syndromes

- ID: D000016739

- Term: Behavior, Addictive

- ID: D000082424

- Term: Internet Addiction Disorder

- ID: D000088942

- Term: Technology Addiction

### Misc Info Module

- Version Holder: 2024-05-24
