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

NCT07174635 | Completed

• 1 other identifier: NTK
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Tele-nursing; Fibromyalgia Syndrome

Keywords

Fibromyalgia (FM); Tele-nursing; Pain; Telehealth

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

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

  At the beginning and at week 8

Other Outcomes (1)

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

  At the beginning and at week 8

Study Arms (2)

Intervention-telenursing

EXPERIMENTAL

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

Controll

NO INTERVENTION

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.

Interventions

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.

Intervention-telenursing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Çankırı Karatekin University: lead

Study Sites (1)

Cankiri Karatekin University

Çankırı, Merkez, 18200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Fibromyalgia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Nedret Tekin Kaya

  https://karatekin.edu.tr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist Prof.

Model Details: The study involved two parallel groups: an intervention group receiving nurse-led telephone counseling and education, and a control group receiving no intervention. Participants were randomly assigned to each group.

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: September 16, 2025
• Study Start: April 10, 2024
• Primary Completion: June 14, 2024
• Study Completion: June 14, 2024
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: For 3 years
• Access Criteria: https://ebap.karatekin.edu.tr/?act=guest\&act2=projeler\&durum=tamam

Locations

TU (1)