Clinical trial NCT06462690: Effect of Care Provided Through Skin Care Protocol on Elderly Patients
Official title: Effect of Care Provided with Skin Care Protocol on Skin Moisture Change, Dermatological Quality of Life and Patient Comfort in Elderly Patients: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly Person
Comfort
Quality of Life
Skin Moisture
Skin
Lead sponsor: Kafkas University
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 42
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental Group Control Group
Primary purpose: PREVENTION

Brief summary: The rate of elderly population is increasing in the world. It is reported that the proportion of the world population over the age of 60 will increase to 22% by 2050. With advancing age, the skin is inevitably affected and becomes more vulnerable to possible damage. Additionally, as the skin ages, it undergoes many internal and external deteriorations. Intrinsic aging refers to biological changes that cannot be prevented to a large extent. External factors; exposure to conditions such as ultraviolet rays and radiation. In addition, in elderly individuals, conditions such as frequent washing, especially washing with harsh products, lack of hygiene, trauma, decreased peripheral satisfaction, immobility, incontinence, diabetes, vascular changes, malnutrition, use of multiple medications, depression, and dementia are among the situations that increase the risk of deterioration in skin health Hypotheses of the Research H0-1=The care given to elderly patients according to the protocol prepared has no effect on the moisture status of the skin.

H1-1= The care given to elderly patients according to the prepared protocol affects the moisture status of the skin.

H0-2== The care given to elderly patients with the prepared protocol has no effect on their dermatological lives.

H1-2== The care given to elderly patients with the prepared protocol has an impact on their dermatological lives.

H0-3= The care provided with the protocol prepared for elderly patients has no effect on general comfort.

H1-3= The care provided with the protocol prepared in elderly patients has an effect on general comfort.

Detailed description: The rate of elderly population is increasing in the world. It is reported that the proportion of the world population over the age of 60 will increase to 22% by 2050. This aging of the population is one of the most important factors affecting the population demographic structure of all countries in the world. These demographic changes create many challenges in all healthcare systems and care settings around the world. Age-related morphological and functional changes affect the whole body, as well as negatively affecting the skin, which is the largest organ of the body. With advancing age, the skin is inevitably affected and becomes more vulnerable to possible damage. Additionally, as the skin ages, it undergoes many internal and external deteriorations. Intrinsic aging refers to biological changes that cannot be prevented to a large extent. External factors; exposure to conditions such as ultraviolet rays and radiation. In addition, in elderly individuals, conditions such as frequent washing, especially washing with harsh products, lack of hygiene, trauma, decreased peripheral satisfaction, immobility, incontinence, diabetes, vascular changes, malnutrition, use of multiple medications, depression, and dementia are. Among the situations that increase the risk of deterioration in skin health. For these reasons, skin care and protecting the integrity of the skin are the main goals of acute and long-term care. Physiological and pathological skin changes occur in the elderly: aged skin contains less collagen elastin and fatty tissue; skin elasticity decreases and shrinkage of the subcutaneous tissue occurs, resulting in the appearance of wrinkles and folds; the skin also has a decreased sebaceous gland and sweat gland activity causes the skin to become dry (xerosis) and more fragile; Arteriosclerotic changes in small and large vessels lead to thinning of the vessel walls and reduced blood flow to the extremities and therefore skin microcirculation.In this study; A protocol that protects the skin health of elderly patients was developed and a randomized controlled experiment was conducted to determine the effect of this protocol on skin moisture, dermatological quality of life and patient comfort in elderly patients. This thesis study is a randomized controlled experimental study with experimental and control groups and three follow-ups. In a similar study in the relevant literature, the effect size for skin moisture difference was calculated as 1.25 in the study conducted by Milani and Sparavigna (2017). In order to exceed the 95% value in determining the power of the study; 36 people, 18 in the groups, should be reached at a significance level of 5% and an effect size of 1.25 (df=34; t=2.032). In the study, it was aimed to reach a total of 44 people, 22 in the groups, considering the high power of the test and the losses.Patient Information Form, Dermatological Quality of Life Index, General Comfort Scale, Elderly Patient's Skin Evaluation Subjective Data Form, Elderly Patient's Skin Evaluation Objective Data Form, Elderly Patient's Pressure Injury Evaluation Form, Skin Moisture Measurement (DMM Skin Moisture Meter Device) will be used. Research data will be evaluated with the SPSS package program. Statistical significance level will be accepted as p\<0.005 and p\<0.001. CONSORT 2018 flow diagram was used in the study.

Eligibility criteria: Inclusion Criteria:

* Individuals who are over 60 years of age, able to communicate, have not taken a bath in the last 24 hours, have not used skin moisture care products, and have not undergone any surgery in the last 6 months who voluntarily participate in the study will be included in the study (Hannel et al. 2017, Matsumoto et al. 2019, Cowdell et al. 2020).

Exclusion Criteria:

* Patients with extreme pain who receive radiotherapy chemotherapy, are allergic to any cleaning agent, and do not volunteer to participate in the study (Konya et al. 2021). He/she will be excluded from the study.

Primary outcomes:
measure: Patient Information Form (PIF)
timeFrame: one week
measure: General Comfort Scale (GCS):
timeFrame: one week
measure: Dermatological Quality of Life index (DLQI)
timeFrame: one week
measure: Elderly Patient's Skin Evaluation Subjective Data Form(EPSESDF)
timeFrame: one week
measure: Elderly Patient's Skin Evaluation Objective Data Form (EPSEODF)
timeFrame: one week
measure: Elderly Patient's Pressure Injury Evaluation Form (EPPIEF)
timeFrame: one week
measure: Elderly Patient's Skin Care and Hygiene Evaluation Forms (EPSCHEF)
timeFrame: one week
measure: Skin Moisture Measurement (DMM)
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
city: Kars
country: Turkey
facility: Kafkas University, Faculty of Health Sciences
state: Turkey/Kars
Study officials:
affiliation: Kafkas University, Faculty of Health Sciences
name: Duygu AKÇA
role: PRINCIPAL_INVESTIGATOR
affiliation: Kafkas University, Faculty of Health Sciences
name: Arzu KARABAĞ AYDIN
role: STUDY_DIRECTOR
References:
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