Effect of Care Provided Through Skin Care Protocol on Elderly Patients

NCT ID: NCT06462690

Last Updated: 2024-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-13

Study Completion Date

2024-10-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Elderly Person Comfort Quality of Life Skin Moisture Skin

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Experimental Group Control Group
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental Group

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.

Group Type EXPERIMENTAL

pre-mid-post test

Intervention Type OTHER

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

Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pre-mid-post test

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Duygu AKÇA

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Duygu AKÇA

Lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Duygu AKÇA

Role: PRINCIPAL_INVESTIGATOR

Kafkas University, Faculty of Health Sciences

Arzu KARABAĞ AYDIN

Role: STUDY_DIRECTOR

Kafkas University, Faculty of Health Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kafkas University, Faculty of Health Sciences

Kars, Turkey/Kars, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 28078772 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34583237 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28947467 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28366230 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29045078 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32006460 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30639096 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31945604 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022-TS-53

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.