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NCT Number: NCT07411508

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

telenursing

Other

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).

Other names: education

face to face education

Other

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).

Other names: face to face, education

Control Arm

Other

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.

Other names: control

Primary outcomes

  1. TELENURSING EDUCATION

    Time frame: Up to the 12th week after educational interventions

    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.

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

    Time frame: Up to the 12th week after educational interventions

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

    Time frame: Up to the 12th week after educational interventions

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

    Time frame: Up to the 12th week after educational interventions

    • 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.

Secondary outcomes

  1. FACE TO FACE EDUCATION

    Time frame: Up to the 12th week after educational interventions

    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.

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

    Time frame: Up to the 12th week after educational interventions

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

    Time frame: Up to the 12th week after educational interventions

    • Urinary tract is used according to presence or absence. 1 point is given if present, 0 points if absent.
  4. FACE TO FACE EDUCATION

    Time frame: Up to the 12th week after educational interventions

    • 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.

Sponsors and collaborators

Lead sponsor

ugurlu

Other

Registry information

Official study 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.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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