PainTele-NursingNCT07174635
The Effect of Tele-Nursing Service in Patients Diagnosed With Fibromyalgia
A study testing Intervention-telenursing in people with Pain and Tele-nursing, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Tele-nursing, Fibromyalgia Syndrome
- What is being tested?
- Intervention-telenursing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Apr 2024to 14 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- People with communication problems
- People with hearing and/or speech problems
- Can't speak Turkish,
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cankiri Karatekin University
Çankırı, Merkez, 18200
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Tele-nursing, Fibromyalgia Syndrome
- Being tested
- Intervention-telenursing
- Keywords
- Fibromyalgia (FM), Tele-nursing, Pain, Telehealth
- Medical subject headings
- Pain, Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention-telenursingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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).
Measured: At the beginning and at week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start10 Apr 2024
- Primary completion14 Jun 2024
- Study completion14 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nedret Tekin Kaya, Çankırı Karatekin University
- Investigators
- Nedret Tekin Kaya, Principal investigator, https://karatekin.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174635
- Sponsor's protocol ID
- NTK
- Acronym
- Tele-Nursing
- Status last verified
- Sep 2025
- First submitted
- 18 May 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tele-Nursing Service on Patients' Pain and Activity Level in Patients Diagnosed With Fibromyalgia
- ClinicalTrials.gov ID
- NCT07174635
- Acronym / sponsor ID
- Tele-Nursing / NTK
- Conditions
- Pain, Tele-nursing, Fibromyalgia Syndrome
- Keywords
- Fibromyalgia (FM), Tele-nursing, Pain, Telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention-telenursing | Experimental | Behavioral: Intervention-telenursingThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- People with communication problems
- People with hearing and/or speech problems
- Can't speak Turkish,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention-telenursingThe 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. | Behavioural | Intervention-telenursing |
Primary outcome
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.
1 secondary outcome
Change in health status as measured by Revised Fibromyalgia Impact Questionnaire (FIQR) at 2 months
Time frame: At the beginning and at week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: Yes. Study Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nedret Tekin Kaya principal investigator
https://karatekin.edu.tr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention-telenursing in people with Pain and Tele-nursing, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.