The Effect of Propolis in Tinea Pedis Treatment: A Randomized Controlled Study
Condition: Nurse's Role; Patient Education; Foot Care
MeSH terms: Tinea Pedis
Study type: Interventional

Summary: 
      Tineapedis is an important health problem. Providing foot care in tinea pedis treatment
      contributes positively to the treatment. In addition, alternative treatments can also be
      used. In this study, the randomization study group will be divided into three. Medical
      treatment and foot care training will be applied to the first group, medical treatment and
      propolis to the second group, medical treatment and plassebo to the control group. Foot care
      training will be given by nurse coaching. Times of all three groups and their response to
      treatment will be evaluated.
    

Detailed description: 
      1. Study Identification: Randomised Controlled Trial

        2. Study Status: This will begin

        3. Sponsor/Collaborators: SBS Scientific Bio Solutions Inc.

        4. Oversight: Patients will be given foot care training. At the same time, a phone call
           will be provided by the research nurse every week. Evaluation will be made at the end of
           2 months

        5. Study Description

           It was planned as a double-blind randomized controlled study. The person conducting the
           randomizer, the person making the statistics and the person performing the medical
           examiner will be blinded. Power analysis was made using the G * Power (3.1.9.4) program,
           0.05 margin of error and 85% power were accepted. A total of 96 people were divided into
           three groups. Groups were composed of 36 people, including 10% losses for each group.

           Inclusion Criteria:

           Not being pregnant Not being breastfeeding Not having confusion Not being
           immunosuppressed Not using systemic cortisone Not having any dermatological problems
           (psoriasis, contact dermatitis, etc.) that will affect the treatment.

           Agree to participate in research Being accessible by phone Having no problems
           communicating by phone Not having problems with physical care

           Exclusion Criteria:

           Pregnant / nursing women Using systemic antifungal therapy Using systemic
           croticosteroids In the process of treatment for oncological reasons Are using
           immunosuppressants Dermatological disease (contact dermatitis, psoriasis) Under the age
           of 18 and over the age of 64 Have cognitive problems There is no telephone / telephone
           number within reach Individuals who have difficulties in speaking and understanding
           Turkish will be excluded from the study.

           Medical treatment applied to all three groups: Sertaconazole nitrate (2%), 1x1,
           externally Terbinafine hydrochloride (250 mg), 1x1, oral Propolis treatment: Alcoholic
           extract of propolis will be used topically 2x1. Plassebe: Sterile distilled water 2x1
           will be used. Plassebo and propolis extrat will be prepared in the same packages.

           Nurse coaching will continue by the nurse, who received coaching training, using the
           training booklet, with the first meeting face-to-face and subsequent calls over the
           phone. Interviews will be held once every two weeks.Each participant will be followed
           for two months. Their treatment and nurse coaching will also continue for two months.
           The nurse coach will coach each patient at least four times. Each coaching session will
           last at least 30 minutes.

           In the evaluation; Dermatological Quality of Life Scale will be used with the global
           evaluation of the patient and the doctor.

           Approval was obtained from Medipol University Traditional and Alternative Medicine
           Practices Ethics Committee for the research.

        6. Conditions and Keywords Propolis, foot care, nursing education

        7. Study Design: Randomised Controlled Trial

        8. Arms, Groups, and Interventions There are 2 experiments and 1 control group in the
           study. Routine antifungal therapy will be applied to all groups. Apart from this, one
           group will be given propolis, another group will be given plassebo. Another group will
           be given foot care training.

        9. Outcome Measures

           Doctor's global assessment Patient's global assesment Dermatological quality of life
           scale

       10. Eligibility The study was planned in accordance with the Turkish Ministry of Health
           rules.

       11. Contacts, Locations, and Investigator Information Rukiye Burucu Necmettin Erbakan
           Üniversitesi Seydişehir SBF Seydişehir/ Konya rburucu@hotmail.com 05062347525

       12. IPD Sharing Statement...
    

Intervention name(s): Propholis extrate
Intervention type(s): Other
Intervention description(s): Plassebo
Other intervention name(s): Nurse coaching/ Nursing education
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a double blind randomized controlled study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nursing; nurse coaching; patient education; complementary therapy; althernative therapy