- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07411508
The Effects of Face-to-face and Tele-nursing Education on Fatigue, Pain, Sleep, and Urinary Tract Infections in Patients With Multiple Sclerosis.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Serdivan
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Sakarya, Serdivan, Turkey (Türkiye), 54050
- Sakarya University Institute of Health Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Education through telenursing services
TELENURSING GROUP: EDUCATION AND SYMPTOM MANAGEMENT PROVIDED ACCORDING TO PENDER'S HEALTH PROMOTION MODEL THROUGH TELENURSING
|
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:
|
|
Experimental: face-to-face education
FACE-TO-FACE GROUP: EDUCATION AND SYMPTOM MANAGEMENT PROVIDED ACCORDING TO PENDER'S HEALTH PROMOTION MODEL THROUGH 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).
Other Names:
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Experimental: control group
CONTROL GROUP
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
TELENURSING EDUCATION
Time Frame: Up to the 12th week after educational interventions
|
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
Time Frame: Up to the 12th week after educational interventions
|
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
Time Frame: Up to the 12th week after educational interventions
|
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
|
|
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. 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. 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
|
|
FACE TO FACE EDUCATION
Time Frame: Up to the 12th week after educational interventions
|
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
|
|
FACE TO FACE EDUCATION
Time Frame: Up to the 12th week after educational interventions
|
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
|
|
FACE TO FACE EDUCATION
Time Frame: Up to the 12th week after educational interventions
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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-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
- 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.
- 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.
- 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.
- 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. (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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Neurologic Manifestations
- Nervous System Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Autoimmune Diseases
- Immune System Diseases
- Infections
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Multiple Sclerosis
- Fatigue
- Urinary Tract Infections
- Professional Practice
- Organization and Administration
- Health Services Administration
- Delivery of Health Care
- Socioeconomic Factors
- Population Characteristics
- Telemedicine
- Patient Care Management
- Nursing
- Educational Status
- Telenursing
Other Study ID Numbers
- E-43012747-050.04-543158_672
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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