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

September 11, 2025 updated by: Nedret Tekin Kaya, Çankırı Karatekin University

The Effect of Tele-Nursing Service on Patients' Pain and Activity Level 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Merkez
      • Çankırı, Merkez, Turkey (Türkiye), 18200
        • Cankiri Karatekin University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention-telenursing
The second researcher did not know which group the patients were in. Thus, both the patient and the researcher who collected the data were blinded. the data collection forms were applied as a pre-test by second researcher. 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. After the completion of the training of the intervention group, the second researcher applied the post-tests to all patients. The FIQR, VAS, and Mcgill pain scale were filled out as the post-tests.
Behavioral: Intervention-telenursing
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.
No Intervention: Controll
The second researcher did not know which group the patients were in. Thus, both the patient and the researcher who collected the data were blinded. The second researcher was given the contact information of all patients and the data collection forms were applied as a pre-test.After the completion of the training of the intervention group, the second researcher applied the post-tests to all patients. The FIQR, VAS, and Mcgill pain scale were filled out as the post-tests. Participants in this group did not receive any counseling or educational intervention. They completed pre- and post-tests during the same period as the intervention group but received standard care only.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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

  1. = Mild
  2. = Discomforting
  3. = Distressing
  4. = Horrible
  5. = Excruciating Higher scores indicate more severe pain.SF-MPQ was administered at baseline and at 2 months post-intervention.
At the beginning and at week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
At the beginning and at week 8

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
At the beginning and at week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Çankırı Karatekin University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nedret Tekin Kaya, https://karatekin.edu.tr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 14, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 14, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NTK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Protocol

IPD Sharing Time Frame

For 3 years

IPD Sharing Access Criteria

https://ebap.karatekin.edu.tr/?act=guest&act2=projeler&durum=tamam

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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