Effect of Care Provided Through Skin Care Protocol on Elderly Patients

NCT06462690 | Completed

• 1 other identifier: 2022-TS-53
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Elderly Person; Comfort; Quality of Life; Skin Moisture; Skin

Outcome Measures

Primary Outcomes (8)

• 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, Tarakçıoğlu Çelik 2019, Kalaycı and Özkul 2019, Dinçer and Kurşun 2019, İn and Akça 2021, Çelenk and Kumcağız 2022, Bekircan and Okanlı 2023).

  one week

• General Comfort Scale (GCS):

  Kolcaba developed the General Comfort Scale (GCS) and published it in 1992. Its Turkish validity and reliability were tested by Kuğuoğlu 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

• 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 Arıkan 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

• 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, Şendir and Büyükyılmaz 2017, Karadakovan 2017, Bayraktar and Faydalı 2017, Jarvis and Eckhardt 2020, Berman et al. 2021, Demir Dikmen 2021) and "Leather Care Prepared in accordance with the protocol

  one week

• 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, Şendir and Büyükyılmaz 2017, Çatıker 2018, Jarvis and Eckhardt 2020).

  one week

• Elderly Patient's Pressure Injury Evaluation Form (EPPIEF)

  Form-related literature (Şendir and Büyükyılmaz 2017, EPUAP/NPIAP/PPPIA 2019, Jarvis and Eckhardt 2020, Ersoy et al. 2018, Şendir 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

• Elderly Patient's Skin Care and Hygiene Evaluation Forms (EPSCHEF)

  The form was prepared in line with the relevant literature (Zaybak A, Güneş 2009, Uğur 2018, Jarvis and Eckhardt 2020, Berman et al. 2021, İn and Akça 2021, Potter et al. 2021).

  one week

• 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

Study Arms (2)

Experimental Group

EXPERIMENTAL

After determining the patients who meet the inclusion criteria and are willing to participate in the study, their consent is obtained and the protocol is applied by the researcher one day before the application, when the patient feels ready, using the face-to-face interview technique (PIF), (DLQI), (GCS), (SEF). Pre-test data is collected by applying it. Vital signs are taken and recorded. Skin moisture is measured with the DMM device. Braden Risk Assessment Scale is applied. After the measurements, the patient is given care according to the care protocol, measurements are made again in between, and then (DLQI), (GCS) is applied, and the skin moisture and vital signs are measured, and the process is concluded.

Other: pre-mid-post test

Control Group

NO INTERVENTION

After the patients who meet the inclusion criteria and are willing to participate in the study are determined, their consent will be obtained and pre-test data will be collected by applying face-to-face interview techniques (PIF), (DLQI), (GCS) at a time when the patient feels ready. Vital signs will be taken and recorded. Skin moisture measurement will be made with a DMM device. Braden Risk Assessment Scale will be applied. After the measurements, according to the care protocol, the patients will not be given care, they will receive routine care, then (DLQI), (GCS) will be applied, skin moisture and vital signs will be measured and the procedure will be terminated.

Interventions

pre-mid-post test OTHER

(PIF) (DLQI) (GCS) Data Collection Forms Humidity measurement with DMM device

Experimental Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duygu AKÇA: lead

Study Sites (1)

Kafkas University, Faculty of Health Sciences

Kars, Turkey/Kars, 36100, Turkey (Türkiye)

Location

Related 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.

  PMID: 28078772 BACKGROUND

• 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.

  PMID: 34583237 BACKGROUND

• 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.

  PMID: 28947467 BACKGROUND

• 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.

  PMID: 28366230 BACKGROUND

• 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.

  PMID: 29045078 BACKGROUND

• 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.

  PMID: 32006460 BACKGROUND

• 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.

  PMID: 30639096 BACKGROUND

• 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.

  PMID: 31945604 BACKGROUND

Study Officials

• Duygu AKÇA

  Kafkas University, Faculty of Health Sciences

  PRINCIPAL INVESTIGATOR

• Arzu KARABAĞ AYDIN

  Kafkas University, Faculty of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants were included in the study using the single-blind randomization method. Block randomization was used in the randomization process. Since the research is a thesis study, double blinding cannot be done because the researcher who collects the data and performs the application is the same. However, blinding will be applied wherever possible in the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: Experimental Group Control Group

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 17, 2024
• Study Start: May 13, 2024
• Primary Completion: September 30, 2024
• Study Completion: October 17, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)