The Effect of Tele-Nursing Service on Patients' Pain and Activity Level in Patients Diagnosed With Fibromyalgia
Phase: NA
Conditions: Pain, Tele-nursing, Fibromyalgia Syndrome
Sponsor: Çankırı Karatekin University

Study Protocol 
Official Title: The Effect of Tele-Nursing Service on Patients' Pain and Activity Level in 
Patients Diagnosed With Fibromyalgia 
Brief Title: The Effect of Tele-Nursing Service in Patients Diagnosed With Fibromyalgia 
Unique Protocol ID: NTK 
NCT Number: [NCTXXXXXXXX] 
Document Date: August 18, 2025 
Sponsor: Çankırı Karatekin University 
Principal Investigator: Assist. Prof. Nedret Tekin Kaya 
IRB Approval: Çankırı Karatekin University Scientific Research Ethics Committee, Approval 
No: 2023/09 
Facility Location: Çankırı Karatekin University, Kırkevler Mahallesi, Kastamonu Caddesi, 
No:244 Uluyazı Kampüsü 18200 Merkez Çankırı, Turkey 
 
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. 
 
  
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. 
 
  
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Conditions 
Conditions: 
Pain 
Tele-nursing 
Fibromyalgia Syndrome   
Keywords: 
Fibromyalgia (FM) 
Tele-nursing 
Pain 
Telehealth   

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Study Design 
Study Type: 
Interventional [Change...] 
Primary Purpose: 
Prevention 
Study Phase: N/A 
Interventional Study Model: Parallel Assignment 
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. 
 
Number of Arms: 
2 
Masking: 
Triple (Participant, Investigator, Outcomes Assessor) 
Allocation: 
Randomized 
Enrollment: 
44 [Actual] 
Open Arms and Interventions 
  
 
Arms Assigned Interventions 
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. 
 
 
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Outcome Measures 
  
Primary Outcome Measure: 
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 
 
= Mild 
= Discomforting 
= Distressing 
= Horrible 
= Excruciating Higher scores indicate more severe pain.SF-MPQ was administered at 
baseline and at 2 months post-intervention. 
[Time Frame: At the beginning and at week 8] 
Secondary Outcome Measures: 
 
Change in health status as measured by Revised Fibromyalgia Impact Questionnaire (FIQR) 
at 2 months 

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). 
 
[Time Frame: At the beginning and at week 8] 
Other Pre-specified Outcome Measures: 
 
Change in pain severity as measured by Visual Analog Scale (VAS) at 2 months 
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. 
 
[Time Frame: At the beginning and at week 8] 
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Eligibility 
Minimum Age: 18 Years   
Maximum Age: 
  
Sex: 
All   
Gender Based: 
No   
Accepts Healthy Volunteers: No   
Criteria: 
 
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, 
Open Contacts/Locations 
Central Contact Person: 
Nedret Tekin Kaya 
    Telephone:   +905055350495 
    Email:   ntekinkaya@karatekin.edu.tr   
Central Contact Backup: 
Nefise C. Sucu Çakmak 
    Email:   ncsucucakmak@karatekin.edu.tr   
Study Officials:  
Nedret Tekin Kaya 
Study Principal Investigator 
https://karatekin.edu.tr   
 Locations: 
 
Turkey 
 
Cankiri Karatekin University      
  
     Cankiri, Merkez, Turkey, 18200   
     Contact: Nedret Tekin Kaya    905055350495    ntekinkaya@karatekin.edu.tr 
     Contact: Nedret Tekin Kaya    
Edit 
IPD Sharing Statement 
Plan to Share IPD: 
Yes 
Study protocol, Informed Concent Form (ICF) 
 

Supporting Information: 
Study Protocol 
Informed Consent Form (ICF) 
Time Frame:  
for 3 years 
 
Access Criteria: 
 
https://ebap.karatekin.edu.tr/?act=guest&act2=projeler&durum=tamam 
 
URL: https://ebap.karatekin.edu.tr/?act=guest&act2=projeler&durum=tamam