NCT07411508

Brief 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. With this research, the researcher aims to reduce MS symptoms and severity, prevent secondary problems, and improve quality of life.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Apr 2024

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

December 8, 2025

Last Update Submit

February 17, 2026

Conditions

Keywords

multiple sclerosisfatiguepainsleepurinary tract infections

Outcome Measures

Primary Outcomes (4)

  • 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.

    Up to the 12th week after educational interventions

  • TELENURSING EDUCATION

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

    Up to the 12th week after educational interventions

  • TELENURSING EDUCATION

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

    Up to the 12th week after educational interventions

  • TELENURSING EDUCATION

    4\. 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.

    Up to the 12th week after educational interventions

Secondary Outcomes (4)

  • FACE TO FACE EDUCATION

    Up to the 12th week after educational interventions

  • FACE TO FACE EDUCATION

    Up to the 12th week after educational interventions

  • FACE TO FACE EDUCATION

    Up to the 12th week after educational interventions

  • FACE TO FACE EDUCATION

    Up to the 12th week after educational interventions

Study Arms (3)

Education through telenursing services

EXPERIMENTAL

TELENURSING GROUP: EDUCATION AND SYMPTOM MANAGEMENT PROVIDED ACCORDING TO PENDER'S HEALTH PROMOTION MODEL THROUGH TELENURSING

Other: telenursing

face-to-face education

EXPERIMENTAL

FACE-TO-FACE GROUP: EDUCATION AND SYMPTOM MANAGEMENT PROVIDED ACCORDING TO PENDER'S HEALTH PROMOTION MODEL THROUGH FACE-TO-FACE EDUCATION

Other: face to face education

control group

EXPERIMENTAL

CONTROL GROUP

Other: Control arm

Interventions

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).

Also known as: education
Education through telenursing services

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).

Also known as: face to face, education
face-to-face education

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.

Also known as: control
control group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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,
  • 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).

You may not qualify if:

  • 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,
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sakarya University Institute of Health Sciences

Sakarya, Serdivan, 54050, Turkey (Türkiye)

Location

Related Publications (15)

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

    RESULT
  • 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.

    RESULT
  • 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.

    RESULT
  • 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).

    RESULT
  • 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.

    RESULT
  • 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).

    RESULT
  • Alonso-Martínez, A. M., Legarra-Gorgoñon, G., García-Alonso, Y., Ramírez-Vélez, R., Alonso-Martínez, L., Erice-Echegaray, B., & Izquierdo, M. 2023. "Gamified family-based health exercise intervention to improve adherence to 24-h movement behaviors recommendations in children: "3, 2, 1 Move on Study". Trials, 24(1), 531. https://doi.org/10.1186/s13063-023-07494-8

    RESULT
  • Chu-Ko, F., Chong, M. L., Chung, C. J., Chang, C. C., Liu, H. Y., & Huang, L. C. (2021). Exploring The Factors Related To Adolescent Health Literacy, Health-Promoting Lifestyle Profile, And Health Status. BMC Public Health, 21(1), 1-12.

    RESULT
  • Jalili Bahabadi, F., Estebsari, F., Rohani, C., Rahimi Khalifeh Kandi, Z., Sefidkar, R., & Mostafaei, D. (2020). Predictors Of Health-Promoting Lifestyle In Pregnant Women Based On Pender's Health Promotion Model. International Journal Of Women's Health, 71-77.

    RESULT
  • Masoudi, R., Lotfizade, M., Gheysarieha, M. R., & Rabiei, L. (2020). Evaluating The Effect Of Pender's Health Promotion Model On Self-Efficacy And Treatment Adherence Behaviors Among Patients Undergoing Hemodialysis. Journal Of Education And Health Promotion, 9.

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

    RESULT
  • 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

    RESULT
  • Dehghani, A., Pourfarid, Y., & Hojat, M. (2023). 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. Multiple Sclerosis And Related Disorders, 70, 104507.

    RESULT
  • Habibzadeh, H., Shariati, A., Mohammadi, F., & Babayi, S. (2021). 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 Cardiovascular Disorders, 21, 1-13.

    RESULT
  • Bijani, M., Niknam, M., Karimi, S., Naderi, Z., & Dehghan, A. (2022). 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 Neurology, 22(1), 144.

    RESULT

MeSH Terms

Conditions

Multiple SclerosisFatiguePainUrinary Tract Infections

Interventions

TelenursingEducational Status

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurologic ManifestationsInfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

NursingProfessional PracticeOrganization and AdministrationHealth Services AdministrationTelemedicineDelivery of Health CarePatient Care ManagementSocioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Because participants and researchers are aware of the assigned groups, double-blinding is not possible. However, study evaluation and scale scoring will be masked wherever possible. The MS medical support team who assisted with survey completion and the statistician who evaluated the data are blinded to the study. (Both groups will be blinded.) Data will be analyzed after the study is completed to support blinding.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Specialist Public Health Nurse, PhD Student in Public Health Nursing

Study Record Dates

First Submitted

December 8, 2025

First Posted

February 13, 2026

Study Start

April 1, 2024

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Based on patient rights and the principle of confidentiality of personal data, I want my data to remain confidential.

Locations