EFFECT OF CARE PROVIDED THROUGH SKIN CARE PROTOCOL ON ELDERLY PATIENTS

Quality of Life Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06462690
• Other study ID #: 2022-TS-53
• Status: Recruiting
• Phase: N/A
• Start date: May 13, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2024
• Source: Kafkas University
• Contact: Duygu AKÇA
• Phone: 05073729521
• Email: duygu.akca36[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (Lichterfeld Kottner et al. 2020). With advancing age, the skin is inevitably affected and becomes more vulnerable to possible damage (Brooks et al. 2017). 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 (Cowdell, 2011). 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 (Cowdell et al. 2015) 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.

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 (Kotner et al. 2020). This aging of the population is one of the most important factors affecting the population demographic structure of all countries in the world (Andrieeva et al. 2019). 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 (Kotner et al. 2020). With advancing age, the skin is inevitably affected and becomes more vulnerable to possible damage (Brooks et al. 2017). 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 (Cowdell, 2011). 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 (Cowdell et al. 2015). For these reasons, skin care and protecting the integrity of the skin are the main goals of acute and long-term care (Konya et al. 2020). 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 (Serra et al. 2017).

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. The effect size in the study was 0.503; The minimum number of samples was determined as 66, taking the alpha value as 0.05 and the power as 0.80. 33 individuals who met the inclusion criteria were included in each group. In order to collect data in the study; 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Comfort
• Elderly Person
• Quality of Life
• Skin

Intervention

Other:
• pre-post test
(PIF) (DLQI) (GCS) Data Collection Forms Humidity measurement with DMM device

Locations

Country	Name	City	State
Turkey	Kafkas University, Faculty of Health Sciences	Kars	Turkey/Kars

Sponsors (1)

Lead Sponsor	Collaborator
Duygu AKÇA

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

Brooks J, Cowdell F, Ersser SJ, Gardiner ED. Skin cleansing and emolliating for older people: A quasi-experimental pilot study. Int J Older People Nurs. 2017 Sep;12(3). doi: 10.1111/opn.12145. Epub 2017 Jan 12. — View Citation

Cowdell F, Jadotte YT, Ersser SJ, Danby S, Lawton S, Roberts A, Dyson J. Hygiene and emollient interventions for maintaining skin integrity in older people in hospital and residential care settings. Cochrane Database Syst Rev. 2020 Jan 23;1(1):CD011377. doi: 10.1002/14651858.CD011377.pub2. — View Citation

Hahnel E, Blume-Peytavi U, Trojahn C, Dobos G, Jahnke I, Kanti V, Richter C, Lichterfeld-Kottner A, Garcia Bartels N, Kottner J. Prevalence and associated factors of skin diseases in aged nursing home residents: a multicentre prevalence study. BMJ Open. 2017 Sep 24;7(9):e018283. doi: 10.1136/bmjopen-2017-018283. — View Citation

Konya I, Iwata H, Hayashi M, Akita T, Homma Y, Yoshida H, Yano R. Effectiveness of weak wiping pressure during bed baths in hospitalized older adults: A single-blind randomized crossover trial. Geriatr Nurs. 2021 Nov-Dec;42(6):1379-1387. doi: 10.1016/j.gerinurse.2021.09.008. Epub 2021 Sep 25. — View Citation

Lichterfeld-Kottner A, El Genedy M, Lahmann N, Blume-Peytavi U, Buscher A, Kottner J. Maintaining skin integrity in the aged: A systematic review. Int J Nurs Stud. 2020 Mar;103:103509. doi: 10.1016/j.ijnurstu.2019.103509. Epub 2019 Dec 23. — View Citation

Matsumoto C, Nanke K, Furumura S, Arimatsu M, Fukuyama M, Maeda H. Effects of disposable bath and towel bath on the transition of resident skin bacteria, water content of the stratum corneum, and relaxation. Am J Infect Control. 2019 Jul;47(7):811-815. doi: 10.1016/j.ajic.2018.12.008. Epub 2019 Jan 10. — View Citation

Serra R, Ielapi N, Barbetta A, de Franciscis S. Skin tears and risk factors assessment: a systematic review on evidence-based medicine. Int Wound J. 2018 Feb;15(1):38-42. doi: 10.1111/iwj.12815. Epub 2017 Oct 17. — View Citation

Shishido I, Yano R. Pilot study on benefits of applying a hot towel for 10 s to the skin of elderly nursing home residents during bed baths: Towards safe and comfortable bed baths. Geriatr Nurs. 2017 Sep-Oct;38(5):442-447. doi: 10.1016/j.gerinurse.2017.02.008. Epub 2017 Mar 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Information Form (PIF)	The patient information form (PIF) was created by the researcher by scanning the literature on the subject (Bickley et al. 2017, Güner et al. 2017, Tarakçioglu Çelik 2019, Kalayci and Özkul 2019, Dinçer and Kursun 2019, In and Akça 2021, Çelenk and Kumcagiz 2022, Bekircan and Okanli 2023).	one week
Primary	General Comfort Scale (GCS):	Kolcaba developed the General Comfort Scale (GCS) and published it in 1992. Its Turkish validity and reliability were tested by Kuguoglu and Karabacak in 2008. For convenience, the four-point Likert type is mostly used. Subdimensions of the scale; relief (16 items), relaxation (17 items) and overcoming problems (15 items). Positive and negative items are given mixed in the scale. In positive questions, 4 points indicate high comfort and 1 point indicates low comfort. In negative questions, 1 point indicates high comfort and 4 points indicate low comfort. When calculating the score from the scale, negative scores are reverse coded and summed with positive items. The highest score of the scale is 192 and the lowest score is 48. Cronbach's alpha value of the Turkish version of the scale is 0.85.	one week
Primary	Dermatological Quality of Life index (DLQI)	The scale was developed by Finlay and Khan in 1994. Turkish validity and reliability were determined by Öztürkcan et al. (2006). There are 10 questions in total, the score varies between 0-30, and there is an inverse relationship between the score obtained and quality of life. It is attempted to determine to what extent the disease-specific symptoms affect people in the last week (Namdar and Arikan 2019). Scoring is as follows: "quite a lot = 3 points", "a lot = 2 points", "slightly = 1 point", "not at all = 0 points" and "not relevant = 0 points", and the scale can vary between 0 and 30 by adding the points of each question. The total score is obtained.	one week
Primary	Elderly Patient's Skin Evaluation Subjective Data Form(EPSESDF)	The form was reviewed by scanning the literature (Weber and Kelley 2014, Lynn 2015, Bickley et al. 2017, Sendir and Büyükyilmaz 2017, Karadakovan 2017, Bayraktar and Faydali 2017, Jarvis and Eckhardt 2020, Berman et al. 2021, Demir Dikmen 2021) and "Leather Care Prepared in accordance with the protocol	one week
Primary	Elderly Patient's Skin Evaluation Objective Data Form (EPSEODF)	The form was created in line with the relevant literature (Weber and Kelley 2014, Lynn 2015, Bickley et al. 2017, Sendir and Büyükyilmaz 2017, Çatiker 2018, Jarvis and Eckhardt 2020).	one week
Primary	Elderly Patient's Pressure Injury Evaluation Form (EPPIEF)	Form-related literature (Sendir and Büyükyilmaz 2017, EPUAP/NPIAP/PPPIA 2019, Jarvis and Eckhardt 2020, Ersoy et al. 2018, Sendir et al. 2021, Horasan 2021, https://sbn.saglik.gov.tr/BKindeksi Access It was created in accordance with the date: 1.01.2024).	one week
Primary	Elderly Patient's Skin Care and Hygiene Evaluation Forms (EPSCHEF)	The form was prepared in line with the relevant literature (Zaybak A, Günes 2009, Ugur 2018, Jarvis and Eckhardt 2020, Berman et al. 2021, In and Akça 2021, Potter et al. 2021).	one week
Primary	Skin Moisture Measurement (DMM)	To evaluate skin moisture, measurements were made with the DMM skin moisture meter. The DMM device measures moisture in any part of the skin. The amount of moisture is measured from the outer surface of this device without causing any damage.	one week