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Multiple SclerosisNCT07411508

The Effects of Face-to-face and Tele-nursing Education on Fatigue, Pain, Sleep, and Urinary Tract Infections in Patients With Multiple Sclerosis.

A study testing telenursing and face to face education in people with Multiple Sclerosis and Education, run by ugurlu at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The aim of this study is to evaluate the effects of face-to-face and distance nursing education, based on Pender's Health Promotion Model, on fatigue, pain, sleep, and urinary tract infections in MS patients who applied to the Multiple Sclerosis Outpatient Clinics of Sakarya Training and Research Hospital. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis, Education, Symptom Management
What is being tested?
telenursing and face to face education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Apr 2024to 1 May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients who are willing to participate in the study,
  • Age between 18-55,
  • Literate,
  • Diagnosed at least 1 year ago,
  • Diagnosed with Relapsing-Remitting MS (the most common type, RRMS, which progresses with attacks and remissions),
  • A specialist (psychologist or psychiatrist) has determined that their cognitive level is suitable for participation in the study,
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  • Scoring their pain 4 points or higher on the Visual Analog Scale (VAS),
  • Scoring 4 or higher on the Fatigue Severity Scale (FSS),
  • Scoring 10 or higher on the Epworth Sleepiness Scale (ESS),
  • Having not used any other complementary and alternative treatments in the last 6 months,
  • Patients who own or have a family member who owns a smartphone, tablet, or computer will be included (Eren, 2018).

Who cannot join

  • Patients who are unwilling to participate in the study for any reason,
  • Have a communication disability,
  • Have a hearing or visual impairment,
  • Have failed to attend three consecutive training sessions unless medically indicated,
  • Have not completed 70% of the training program (or 17 of 24 sessions) (Alonso Martínez et al., 2023),
  • Have developed serious physical or mental illnesses during the study period,
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  • Have been found to be unsuitable for participation in the study (as assessed by a psychologist or psychiatrist),
  • Have used other complementary therapies such as acupuncture, yoga, meditation, etc. during the study period,
  • Have been in an attack phase of the disease or have conditions requiring hospitalization during the intervention will not be included in the study.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Sakarya University Institute of Health Sciences

    Sakarya, Serdivan, 54050

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Effects of Education Provided Through Face-to-face and Tele-nursing Based on Pender's Health Promotion Model on Fatigue, Pain, Sleep, and Urinary Tract Infections ın Patients With Multiple Sclerosis: a Randomized Controlled Trial.

The aim of this study is to evaluate the effects of face-to-face and distance nursing education, based on Pender's Health Promotion Model, on fatigue, pain, sleep, and urinary tract infections in MS patients who applied to the Multiple Sclerosis Outpatient Clinics of Sakarya Training and Research Hospital. With this research, the researcher aims to reduce MS symptoms and severity, prevent secondary problems, and improve quality of life.

Read the detailed description

Education is a crucial aspect of disease management in MS patients. A strategy aimed at improving patients' health and health behaviors, education provides benefits such as increasing their quality of life, self-efficacy, and confidence in ongoing care, reducing anxiety and stress, decreasing the frequency of disease symptoms, increasing patient participation in care plans, and improving their autonomy and self-management. Selecting the appropriate educational model is the first step in educational planning, and one of the most comprehensive and widely used models offered by nurses for patient education is Pender's Health Promotion Model.

Introduced by Pender in 1982, Pender's Health Promotion Model (HPLP) focuses on enabling people to achieve higher levels of well-being. The model encompasses six areas of health promotion, including nutrition, physical activity (exercise), health responsibility, stress management, interpersonal relationships, and self-actualization, as well as the factors that influence these areas.

Telenursing is a method that allows nurses to receive training to improve nursing services and enhance patient well-being. Telenursing is considered a component of telemedicine and, by definition, enables nurses to meet patients' healthcare needs through information and communication technologies. Telenursing offers a tool for providing continuous care to patients with chronic illnesses. This allows patients to receive the care they need without the need for long journeys, at a low cost, and in a way that positively impacts their recovery process.

Being tested
telenursing, face to face education, Control arm
Keywords
multiple sclerosis, fatigue, pain, sleep, urinary tract infections
Medical subject headings
Multiple Sclerosis, Fatigue, Pain, Urinary Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • telenursingOther

    Also called education

    The nurse researcher developed training modules for MS symptoms (pain, fatigue, sleep, and urinary tract infections) in consultation with experts. These training modules were then presented via an online application (e.g., WhatsApp software or internet access address creation) with the approval and support of training and IT experts. In this context, volunteer patients who met the study criteria received training three days a week for six weeks via telenursing. Furthermore, as part of the telenursing program, patients were given the opportunity to call the researcher for 10-15 minutes from 8 a.m. to 8 p.m. on weekdays if they needed telephone consultation (Dehghani et al., 2023).

  • face to face educationOther

    Also called face to face, education

    A focus group training program was planned for patients who met the study inclusion criteria during the MS Outpatient Clinic Days (Tuesday-Thursday, 9:00-16:00) at Sakarya Training and Research Hospital. The training, prepared according to Pender's Health Promotion Model , was provided by the research nurse. The literature suggests that the ideal number of focus group interviews should be 4-10 people, and that the number of groups should not exceed 10 to facilitate group dynamics and interaction. In our study, a total of 3-5 focus group training sessions were conducted (Öner and Karabudak, 2021; Çokluk et al., 2011).

  • Control armOther

    Also called control

    The control group received no intervention, and patients continued to receive their routine treatments. At the end of the study, volunteers in the control group received an Pender's Health Promotion Model-based education program prepared by the research nurse, either face-to-face or via telenursing, at their request.

Study groups in NCT07411508
Study groupRoleWhat they receive
Education through telenursing servicesExperimentalTELENURSING GROUP: EDUCATION AND SYMPTOM MANAGEMENT PROVIDED ACCORDING TO PENDER'S HEALTH PROMOTION MODEL THROUGH TELENURSING
Receives: Other: telenursing
face-to-face educationExperimentalFACE-TO-FACE GROUP: EDUCATION AND SYMPTOM MANAGEMENT PROVIDED ACCORDING TO PENDER'S HEALTH PROMOTION MODEL THROUGH FACE-TO-FACE EDUCATION
Receives: Other: face to face education
control groupExperimentalCONTROL GROUP
Receives: Other: Control arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. TELENURSING EDUCATION

    Based on Pender's Health Enhancement Model, telenursing provides education to MS patients, reducing patient fatigue, pain intensity, and urinary tract infections, while improving patient sleep quality.

    1. The total score obtained from the application of fatigue technology (FSS) is reduced as it decreases; a higher score indicates increased fatigue.

    Measured: Up to the 12th week after educational interventions

  2. TELENURSING EDUCATION

    1. Pain is determined using a visual analog scale (VAS) with marking on a 10 cm ruler, indicator marking (0 = no pain, 10 = unbearable pain).

    Measured: Up to the 12th week after educational interventions

  3. TELENURSING EDUCATION

    1. Urinary tract is used according to presence or absence. 1 point is given if present, 0 points if absent.

    Measured: Up to the 12th week after educational interventions

  4. TELENURSING EDUCATION

    1. Epworth sleep performance state (ESS) uses 0, 1, 2, and 3-wire systems; higher scores indicate increased daytime sleepiness. A total score between 0 and 24 can be obtained from the scale.

    Measured: Up to the 12th week after educational interventions

Secondary outcomes (4)

  1. FACE TO FACE EDUCATION

    Pender's face-to-face patent training, based on his health improvement model, reduces pain, pain crying, and exhaustion in MS patients while also improving sleep quality.

    1. The total score obtained from the application of fatigue technology (FSS) is reduced as it decreases; a higher score indicates increased fatigue.

    Measured: Up to the 12th week after educational interventions

  2. FACE TO FACE EDUCATION

    1. Pain is determined using a visual analog scale (VAS) with marking on a 10 cm ruler, indicator marking (0 = no pain, 10 = unbearable pain).

    Measured: Up to the 12th week after educational interventions

  3. FACE TO FACE EDUCATION

    1. Urinary tract is used according to presence or absence. 1 point is given if present, 0 points if absent.

    Measured: Up to the 12th week after educational interventions

  4. FACE TO FACE EDUCATION

    1. Epworth sleep performance state (ESS) uses 0, 1, 2, and 3-wire systems; higher scores indicate increased daytime sleepiness. A total score between 0 and 24 can be obtained from the scale.

    Measured: Up to the 12th week after educational interventions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2026
  2. Study start1 Apr 2024
  3. Primary completion1 Apr 2026 (estimated)
  4. Study completion1 May 2026 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study population will consist of patients diagnosed with MS who present to the Multiple Sclerosis Outpatient Clinics of the Department of Neurology at Sakarya Education and Research Hospital. A total of 3,552 patients have been admitted to the Multiple Sclerosis Outpatient Clinics in the last year. Participants will be assigned to the intervention and control groups according to their order of presentation to the clinic, using computer-assisted block randomization to ensure an equal and homogeneous number of participants in each group. Considering the possibility of participants who did not meet the study criteria withdrawing from the study, 90 randomly selected participants from the population will be randomly assigned to the experimental and control groups (Group 1, Group 2, and Group 3), each consisting of 30 patients with MS.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07411508
Sponsor's protocol ID
E-43012747-050.04-543158_672
Status last verified
Feb 2026
First submitted
8 Dec 2025
Last updated
19 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Based on patient rights and the principle of confidentiality of personal data, I want my data to remain confidential.

Publications

  • Demir, G., & Kesgin, M. T. (2020),Lise Öğrencilerinde Gündüz Uykululuk Durumu Ve İlişkili Risk Etmenleri, Journal Of Turkish Sleep Medicine-Turk Uyku Tibbi Dergisi.

  • Rujnan, T., Çaykara, B., Sağlam, Z., & Pençe, H. H. (2019), Sigara Bağımlılarında Depresyon, Anksiyete, Uykululuk Ve Uyku Kalitesi Düzeyleri Arasındaki İlişkinin Belirlenmesi, Acıbadem Üniversitesi Sağlık Bilimleri Dergisi, (4), 609-615.

  • Pekçetin, S., Irmak, D. E., İnal Ö., Özkan, H., Kehaya, S., & Kayıhan, H. (2019), Multipl Skleroz Hastalarında Algılanan Yorgunluğun Aktivite-Rol Yeterliliği İle İlişkisi, Ergoterapi Ve Rehabilitasyon Dergisi, 7(2), 79-84.

  • Kaya, T., Karatepe, A. G., Demirhan, A., Günaydın, R., Gedizlioğlu, M., & Çe, P. (2009), Multipl Sklerozlu Hastalarda Yorgunluk ve İlişkili Faktörler, Journal of Neurological Sciences, 26(2).

  • Arslan, M., Albaş, S., Küçükerdem, H. S., Pamuk, G., & Can, H. (2016),Vizüel Analog Skala İle Kanser Hastalarında Palyatif Ağrı Tedavisinin Etkinliğinin Değerlendirilmesi, Family Practice & Palliative Care, 1(1), 5-8.

  • Güven, Ş. Ş., Özcan, D. S., Aras, M., Köseoğlu, B. F., & Ak, F. (2016), Multipl Sklerozlu Hastalarda Ağrının Değerlendirilmesi Ve Yaşam Kalitesi, Yorgunluk Ve Depresyon İle İlişkisi,Turkish Journal Of Physical Medicine & Rehabilitation/Turkiye Fiziksel Tip Ve Rehabilitasyon Dergisi, 62(2).

  • Alonso-Martinez AM, Legarra-Gorgonon G, Garcia-Alonso Y, Ramirez-Velez R, Alonso-Martinez L, Erice-Echegaray B, Izquierdo M. Gamified family-based health exercise intervention to improve adherence to 24-h movement behaviors recommendations in children: "3, 2, 1 Move on Study". Trials. 2023 Aug 14;24(1):531. doi: 10.1186/s13063-023-07494-8.

    PubMed 37580788

  • Chu-Ko F, Chong ML, Chung CJ, Chang CC, Liu HY, Huang LC. Exploring the factors related to adolescent health literacy, health-promoting lifestyle profile, and health status. BMC Public Health. 2021 Dec 1;21(1):2196. doi: 10.1186/s12889-021-12239-w.

    PubMed 34852793

  • Jalili Bahabadi F, Estebsari F, Rohani C, Rahimi Khalifeh Kandi Z, Sefidkar R, Mostafaei D. Predictors of Health-Promoting Lifestyle in Pregnant Women Based on Pender's Health Promotion Model. Int J Womens Health. 2020 Feb 24;12:71-77. doi: 10.2147/IJWH.S235169. eCollection 2020.

    PubMed 32158276

  • Masoudi R, Lotfizade M, Gheysarieha MR, Rabiei L. Evaluating the effect of Pender's health promotion model on self-efficacy and treatment adherence behaviors among patients undergoing hemodialysis. J Educ Health Promot. 2020 Aug 31;9:197. doi: 10.4103/jehp.jehp_747_19. eCollection 2020.

    PubMed 33062730

  • Ghoulami-Shilsari, F., & Bandboni, M. E. (2019). Tele-Nursing In Chronic Disease Care: A Systematic Review. Jundishapur Journal Of Chronic Disease Care, 8(2).

  • Eren, F. (2018). Koroner Arter Bypass Greft Ameliyatı Geçiren Hastalara Taburculuk Sonrası Tele-Hemşirelik Hizmeti İle Verilen Danışmanlığın, Depresyon Anksiyete Ve Stres Düzeyine Etkisi. T.C. Akdeniz Üniversitesi Sağlık Bilimleri Enstitüsü Hemşirelik Anabilim Dalı, Yüksek Lisans Tezi

  • Dehghani A, Pourfarid Y, Hojat M. The effect of telenursing education of self-care on health-promoting behaviors in patients with multiple sclerosis during the COVID-19 pandemic: A clinical trial study. Mult Scler Relat Disord. 2023 Feb;70:104507. doi: 10.1016/j.msard.2023.104507. Epub 2023 Jan 5.

    PubMed 36682241

  • Habibzadeh H, Shariati A, Mohammadi F, Babayi S. The effect of educational intervention based on Pender's health promotion model on quality of life and health promotion in patients with heart failure: an experimental study. BMC Cardiovasc Disord. 2021 Oct 5;21(1):478. doi: 10.1186/s12872-021-02294-x.

    PubMed 34610821

  • Bijani M, Niknam M, Karimi S, Naderi Z, Dehghan A. The effect of peer education based on Pender's health promotion model on quality of life, stress management and self-efficacy of patients with multiple sclerosis: a randomized controlled clinical trial. BMC Neurol. 2022 Apr 18;22(1):144. doi: 10.1186/s12883-022-02671-9.

    PubMed 35436876

Questions about this trial

What is this clinical trial studying?

A study testing telenursing and face to face education in people with Multiple Sclerosis and Education, run by ugurlu 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 11 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 19 Feb 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

TELENURSING EDUCATION (time frame: Up to the 12th week after educational interventions). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07411508, which also lists 15 linked publications.

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 19 Feb 2026.

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