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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05909891
Other study ID # B.30.2.ATA.0.01.00/416
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date February 1, 2024

Study information

Verified date June 2023
Source Ataturk University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Iron Deficiency Anemia is an important health problem. Iron deficiency anemia constitutes half of the anemia seen in the world, and children and women constitute the group with iron deficiency anemia in our country (Internal Medicine Nursing Book with Case Scenarios, 2019; Turkey Program Guide as Iron). The treatment is iron replacement by oral or parenteral route (Guzelcuk, Ozbek, 2017). Due to the side effects of the drugs given in the treatment, the patients have difficulty in adapting to the treatment and there is a change in their fatigue levels (Guzelcuk, Özbek, 2017; Guide, 2019; Çipil, Demircioğlu, 2016). It is thought that the education given to the patients will increase their compliance with the treatment. It is thought that patients' hospital admissions and fatigue levels may change in the failure to comply with the treatment. In this study, the effect of the education given on the treatment compliance and fatigue of the patients will be investigated. This research will help patients with iron deficiency anemia whether they need education, the importance of treatment compliance and their fatigue levels.


Description:

Iron Deficiency Anemia (DEA) is one of the acquired anemia, which is seen as a result of insufficient intake of iron necessary for the body or rapid decrease in iron stores (Internal Medicine Nursing Book with Case Scenarios, 2019). It is the most common anemia in the world and constitutes 50% of anemias (Internal Medicine Nursing Book with Case Scenarios, 2019). It is stated that the incidence is increasing in low-income societies (As Iron Turkey Program Guide; Erduran ,2010). In studies on adults, the frequency of IDA is around 20%, and it is most commonly seen in women due to pregnancy and menstruation (Iron Deficiency and Iron Deficiency Anemia Clinical Protocol, 2020). The aim of the "Turkey Like Iron" program, which was started in our country in 2004, is to try to prevent iron deficiency anemia as new generations are the adults of the future (As Iron Turkey Program Guide). The most common findings in patients with iron deficiency anemia are fatigue, weakness, activity intolerance, hair loss and thinning, thinning-breaking-flattening of nails, and headache (Dağ, Kıyak, 2021; Guide, 2019). The reason for fatigue, which is one of these symptoms, is the decrease in the amount of oxygen carried to the tissues as a result of the low hemoglobin level in the blood (Dağ, Kıyak, 2021). Depending on the inability to carry enough oxygen to the muscles, activity intolerance occurs in people (Dağ, Kıyak, 2021). The degree of anemia affects the severity of fatigue (Dağ, Kıyak, 2021). The severity of fatigue also affects the person's ability to perform activities of daily living (Ovayolu, Ovayolu, 2017). Oral or parenteral iron replacements are used in the treatment of anemia that causes fatigue and activity intolerance (Kılavuz, 2019). However, some side effects may be seen in patients due to the use of oral iron drugs (Kılavuz,2019; Çipil, Demircioğlu, 2016). These side effects are stated as tooth discoloration, nausea, vomiting, indigestion, constipation, diarrhea, and darkening of stool color (Kılavuz, 2019; Çipil, Demircioğlu, 2016). Patients cannot continue treatment due to these side effects (Kılavuz,2019; Çipil, Demircioğlu, 2016). Trainings given to patients to increase adherence to treatment can be effective in coping with the treatment process and side effects (Aydemir Geduk, 2018). It is stated that the symptoms experienced by the patients who continue the treatment will decrease in a short time such as 1 month (Çipil, Demircioğlu, 2016; Bolaman, 2004). However, it was stated by the experts that the treatment should be continued for 3-6 months in order to replace the iron stores (Guide, 2019). When the increase in the hemoglobin values of the patients who continue the treatment and the oxygen carried to the tissues reach a sufficient level, the symptoms such as fatigue and activity intolerance will decrease and disappear over time (Kılavuz, 2019; Dağ, Kıyak, 2021). Considering the authorities and responsibilities of the nursing profession, one of the most important is to provide training in line with the needs of the patient and their relatives. Nurses provide training to individuals in order to protect and improve the health of the individual, family and society, and to gain the right health behaviors to improve in case of illness (Aydemir Geduk, 2018). From past to present, training given to patients by healthcare professionals increases patients' adherence to treatment (Yel, Kardadakovan, 2021).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date February 1, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Orientation to person, place and time 2. Having no problems communicating 3. To voluntarily agree to participate in the research 4. Being diagnosed with iron deficiency anemia 5. Being between the ages of 18-65 6. Being able to read and write 7. Receiving oral iron medication for at least 1 month 8. Those with low Morisky scale motivation score Exclusion Criteria: 1. Individuals under the age of 18 2. Foreign nationals 3. Those with maling disease 4. Pregnant

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Patient training
A training booklet will be created by scanning the literature on iron deficiency anemia. The training booklet will be evaluated in terms of content and readability, according to the DISCERN measurement tool, while obtaining expert opinion. The training period will be at least 35-40 minutes, taking into account the educational status of the patient and explaining the importance of compliance with the treatment. After the training, when the patients come to the routine check-ups in the 1st and 2nd months, the level of compliance with the treatment and the fatigue of the patients will be evaluated.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ataturk University

Outcome

Type Measure Description Time frame Safety issue
Primary Modified Morisky Scale The scale was created by Morisky et al. (1986) in 1986 to evaluate adherence to antihypertensive drug therapy. Validity and reliability of the Modified Morisky Scale used in many studies for chronic diseases Vural et al. (2012) by The scale consists of 6 questions to evaluate adherence to long-term drug therapy in chronic diseases and can evaluate motivation and knowledge level separately. Scale questions are answered as Yes/No, and yes 1 point, no 0 point; in other questions, yes is calculated as 0 points and no as 1 point. If the total score obtained from questions 1,2 and 6 of the scale is 0 or 1, it indicates low motivation level, and >1 indicates high motivation level. If the total score obtained from the 3,4 and 5 questions of the scale is 0 or 1, it indicates low knowledge level, and >1 indicates high knowledge level. avarage of six mounth
Primary Visual Similarity Scale for Fatigue The Turkish validity and reliability scale was made by Yurtsever, and it was created by Lee et al. (1990) in 1990. The scale consists of 18 items, fatigue (1. 2. 3. 4. 5. 11. 12. 13. 14. 15. 16. 17. and 18. items) and energy level (6. 7. 8. 9 and 10. items) consists of sub-dimensions. There are 10 cm lines in each statement of the scale, and there is a positive statement at one end of the line and a negative statement at the other. These statements are scored between 0 and 10. The items of the fatigue subscale range from the most positive to the most negative, while the items of the energy subscale range from the most negative to the most positive. An increase in the fatigue subscale score indicates an increase in the severity of fatigue, and an increase in the energy subscale score indicates an increase in energy. Getting a high score on the fatigue questions and a low score on the energy questions indicate that the severity of fatigue is high. avarage of six mounth
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