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

NCT ID: NCT07174635

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-10
• Study Completion Date: 2024-06-14

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.

Conditions

Pain; Tele-nursing; Fibromyalgia Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intervention-telenursing

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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,

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Çankırı Karatekin University

OTHER

Sponsor Role: lead

Responsible Party

Nedret Tekin Kaya

Assist Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nedret Tekin Kaya

Role: PRINCIPAL_INVESTIGATOR

https://karatekin.edu.tr

Locations

Cankiri Karatekin University

Çankırı, Merkez, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NTK

Identifier Type: -

Identifier Source: org_study_id