Elderly PersonNCT06462690
Effect of Care Provided Through Skin Care Protocol on Elderly Patients
A study testing pre-mid-post test in people with Elderly Person and Comfort, run by Duygu AKÇA at 1 site in Turkey (Türkiye).
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. With advancing age, the skin is inevitably affected and becomes more vulnerable to possible damage. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Elderly Person, Comfort, Quality of Life
- What is being tested?
- pre-mid-post test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 May 2024to 17 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kafkas University, Faculty of Health Sciences
Kars, Turkey/Kars, 36100
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Elderly Person, Comfort, Quality of Life, Skin Moisture, Skin
- Being tested
- pre-mid-post test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pre-mid-post testOther
(PIF) (DLQI) (GCS) Data Collection Forms Humidity measurement with DMM device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start13 May 2024
- Primary completion30 Sep 2024
- Study completion17 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Elderly PersonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental Group Control Group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duygu AKÇA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Duygu AKÇA, Kafkas University
- Investigators
- Duygu AKÇA, Principal investigator, Kafkas University, Faculty of Health SciencesArzu KARABAĞ AYDIN, Study director, Kafkas University, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462690
- Sponsor's protocol ID
- 2022-TS-53
- Status last verified
- Oct 2024
- First submitted
- 12 Jun 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28078772Konya 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.
PubMed 34583237Hahnel 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.
PubMed 28947467Shishido 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.
PubMed 28366230Serra 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.
PubMed 29045078Cowdell 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.
PubMed 32006460Matsumoto 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.
PubMed 30639096Lichterfeld-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.
PubMed 31945604
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06462690
- Acronym / sponsor ID
- 2022-TS-53
- Conditions
- Elderly Person, Comfort, Quality of Life, Skin Moisture, Skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Duygu AKÇAUniversity, hospital or other
- Study start
- 13 May 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental Group Control Group
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: pre-mid-post testAfter 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. |
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pre-mid-post test(PIF) (DLQI) (GCS) Data Collection Forms Humidity measurement with DMM device | Other | Experimental Group |
Primary outcome
Patient Information Form (PIF)
Time frame: one week
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).
General Comfort Scale (GCS):
Time frame: one week
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.
Dermatological Quality of Life index (DLQI)
Time frame: one week
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.
Elderly Patient's Skin Evaluation Subjective Data Form(EPSESDF)
Time frame: one week
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
Elderly Patient's Skin Evaluation Objective Data Form (EPSEODF)
Time frame: one week
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).
Elderly Patient's Pressure Injury Evaluation Form (EPPIEF)
Time frame: one week
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).
Elderly Patient's Skin Care and Hygiene Evaluation Forms (EPSCHEF)
Time frame: one week
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).
Skin Moisture Measurement (DMM)
Time frame: one week
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Background: PubMed 28078772Brooks 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.
- Background: PubMed 34583237Konya 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.
- Background: PubMed 28947467Hahnel 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.
- Background: PubMed 28366230Shishido 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.
- Background: PubMed 29045078Serra 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.
- Background: PubMed 32006460Cowdell 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.
- Background: PubMed 30639096Matsumoto 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.
- Background: PubMed 31945604Lichterfeld-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.
- Individual participant dataSharing planned: No
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A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
Not yet recruiting
Pilates vs. Core Stabilization for Balance and Mobility in Elderly Type 2 Diabetics
Mellitus Balance Deficits Postural Balance Mobility Limitation, Type 2 Diabetes Mellitus
Not yet recruitingPhase 2
Proton Moderately Hypofractionated Radiotherapy in NSCLC Patients Unable to Tolerate Standard Concurrent Chemoradiotherapy
Non-Small Cell Lung Cancer
Recruiting
Lumbar Paravertebral Block vs Erector Spinae Plane Block in Elderly Patients Undergoing Lumbar Spine Surgery
Spine Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duygu AKÇA principal investigator
Kafkas University, Faculty of Health Sciences
Arzu KARABAĞ AYDIN study director
Kafkas University, Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pre-mid-post test in people with Elderly Person and Comfort, run by Duygu AKÇA at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Information Form (PIF) (time frame: one week). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06462690, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.