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Completed

NCT Number: NCT07174635

The Effect of Tele-Nursing Service in Patients Diagnosed With Fibromyalgia

The aim of the study was to determine the effect of tele-nursing service provided to patients diagnosed with fibromyalgia on the pain and activity level of patients. The study was designed as a randomised controlled experimental study in a pretest-posttest design. The research was conducted in a State Hospital between April 2024 and June 2024 with patients diagnosed with fibromyalgia who applied to the physical therapy outpatient clinic and met the inclusion criteria. The sample was divided into two groups as intervention and control groups of 22 participants by simple randomisation. Descriptive Information Form, Fibromyalgia Impact Questionnaire Revised (FIQR), Mcgill Pain Scale were used as data collection tools in the study. The second researcher was given the contact information of all patients and the data collection forms were applied as a pre-test. The second researcher did not know which group the patients were in. Thus, the researcher collecting the data was blinded. Data collection forms were administered by the researcher by interviewing the patient in approximately 15-20 minutes. Patients in the intervention group were called three times by phone and were trained in accordance with the prepared training booklet by first researcher.

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Key information

Conditions

Pain Fibromyalgia Fibromyalgia Syndrome Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Tele-nursing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cankiri Karatekin University

Çankırı, Merkez, 18200, Turkey (Türkiye)

About this study

Fibromyalgia is a chronic condition of unknown etiology, characterized by widespread musculoskeletal pain, sleep disturbances, fatigue, anxiety, and impaired cognitive functions.Fibromyalgia-related pain often increases during or after physical activity and may interfere with patients' ability to perform daily living activities. Despite extensive research, the exact cause of the disease remains unknown.

This study aimed to evaluate the effectiveness of nurse-led telephone counseling on pain severity and physical activity levels in patients who met the inclusion criteria. A total of 44 participants were enrolled: 22 in the intervention group (who received telephone-based counseling and education from a nurse) and 22 in the control group (who received no intervention).

All participants were informed about the study, and written informed consent was obtained. At baseline, all patients completed pre-test questionnaires. The intervention group received additional follow-up through two telephone calls during the intervention period.

The nurse provided education and counseling on various topics, including pain management strategies, ways to increase physical activity, appropriate exercise, and stress coping techniques. Non-pharmacological treatment options for pain relief were also discussed. The educational intervention lasted approximately 4 weeks.

Following the completion of the intervention, post-tests were administered to all participants. Two months after the intervention, the FIQR (Fibromyalgia Impact Questionnaire-Revised),and the McGill Pain Questionnaire were completed by all patients to assess outcomes.

Ethical Considerations Prior to the initiation of the study, ethical approval was obtained from the Institutional Scientific Research Ethics Committee. The study was conducted in accordance with the principles of the Declaration of Helsinki. Participants were informed that their involvement was voluntary and that they could withdraw from the study at any time without any consequences.

Statistical analysis The data were analyzed using IBM SPSS Statistics version 26.0. Group comparisons were performed using independent-samples t-tests and ANOVA. Statistical significance was set at p<0.05. The data were analyzed using IBM SPSS Statistics version 26.0. Group comparisons were performed using independent-samples t-tests and ANOVA. Statistical significance was set at p<0.05. Descriptive data were shown with mean, standard deviation, median, number and percentage. Socio-demographic differences between the intervention and control groups were analyzed using Chi-squared tests for nominal variables and independent samples t-tests for continuous variables. Paired t test was used to determine the difference between two normally distributed groups and independent t test was used for nonnormally distributed variables.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals diagnosed with fibromyalgia
  • Aged 18 years or older
  • No communication impairments that would hinder participation in the study or the ability to receive education (e.g., hearing loss, visual impairment, or difficulty understanding/speaking Turkish)
  • Reachable by phone
  • Literate
  • Willing to participate voluntarily.

Exclusion criteria

  • People with communication problems
  • People with hearing and/or speech problems
  • Can't speak Turkish,

Treatment and study plan

Intervention-telenursing

Behavioral

The first researcher sent an educational booklet prepared on the educational topics or the topics the patient needed to the patients in the experimental group as a message. The patient was then called by phone and informed about the educational booklet. After the main interview, the patients were called 2 more times for follow-up. The intervention group was given education on topics such as reducing pain complaints, increasing activity level, exercise, and coping with stress. The education of the intervention group lasted approximately 4 weeks.

Primary outcomes

  1. Change in pain severity as measured by the Short Form McGill Pain Questionnaire (SF-MPQ) sensory subscale at 2 months

    Time frame: At the beginning and at week 8

    The Short Form McGill Pain Questionnaire (SF-MPQ) is a widely used tool for assessing the qualitative and quantitative aspects of pain.The SF-MPQ consists of three main components:

    1-Pain Rating Index (PRI) - Divided into: Sensory subscale: 11 descriptors (e.g., throbbing, shooting, stabbing) Affective subscale: 4 descriptors (e.g., tiring, fearful, punishing) Each descriptor is rated on a 4-point scale:0 = None,1 = Mild,2 = Moderate,3 = Severe.

    A 6-point ordinal scale where the participant selects one of the following to describe their current pain:

    0 = No pain

    • = Mild
    • = Discomforting
    • = Distressing
    • = Horrible
    • = Excruciating Higher scores indicate more severe pain.SF-MPQ was administered at baseline and at 2 months post-intervention.

Secondary outcomes

  1. Change in health status as measured by Revised Fibromyalgia Impact Questionnaire (FIQR) at 2 months

    Time frame: At the beginning and at week 8

    The Revised Fibromyalgia Impact Questionnaire (FIQR) is a patient-reported outcome measure designed to assess the health status and impact of fibromyalgia on daily life. The FIQR is a revised version of the original FIQ, providing better psychometric properties and more comprehensive coverage of functional domains.The FIQR is a 21-item questionnaire measuring the impact of fibromyalgia across function, overall impact, and symptom domains. Each item is scored from 0 (no impact) to 10 (maximum impact). The total score ranges from 0 to 100, with higher scores indicating worse fibromyalgia-related health status. FIQR was administered at baseline and at 2 months post-intervention.

    The FIQR consists of 21 items divided into 3 domains:

    Function domain (9 items) - assesses physical functioning

    Overall impact domain (2 items) - measures overall impact of fibromyalgia

    Symptom domain (10 items) - evaluates common fibromyalgia symptoms (e.g., pain, fatigue, sleep quality).

Other outcomes

  1. Change in pain severity as measured by Visual Analog Scale (VAS) at 2 months

    Time frame: At the beginning and at week 8

    The Visual Analog Scale measures pain severity on a scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain.VAS was administered at baseline and at 2 months post-intervention.

Sponsors and collaborators

Lead sponsor

Çankırı Karatekin University

Other

Registry information

Official study title

The Effect of Tele-Nursing Service on Patients' Pain and Activity Level in Patients Diagnosed With Fibromyalgia

Acronym: Tele-Nursing

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Sep 16, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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