Itching Clinical Trial
Official title:
Comparison of the Effects of Liquid Vaseline and Olive Oil on Itching and Scarring in Scald Burns
Pain, itching, hypertrophic scar formation after wound healing in burn patients complications, sleep disturbances in patients, anxiety, depression, and daily life It may disrupt activities and deterioration in quality of life. Liquid petroleum jelly and olive oil have no side effects, moisturizing properties, or wound-healing treatment of burns due to their positive effects on symptoms such as itching. can be used to alleviate burns. The project found the use of liquid petroleum jelly and olive oil to determine the effect on itching and scarring in burn patients. After burns reduction of symptoms such as itching, dryness, hypertrophic scarring, and patient comfort. Provision of care is a part of nursing care. In studies, itching and scarring there is insufficient evidence regarding the treatment methods applied for its treatment is observed. In addition, the effect of olive oil and liquid petroleum jelly on itching and scarring no scientific study was found. The results of the project were found to be significant in terms of post-burn itching providing evidence of hypertrophic scar management and contributing to ongoing studies is expected to be found. Since there are no similar studies in the literature, a preliminary study with 24 patient applications will be made. In line with the data obtained from the pre-application, the sample calculation will be made and the application will continue by making the necessary arrangements. Patients will be divided into experimental and control groups by simple randomization. All patient groups individual data collection forms on the first day; 12 individual data collection forms on the first day, 15th day, first, second, and third months Itemized Itch Severity Scale, Patient and Observer Scar Scale to be applied in Burn Patients and the wound area will be photographed. Patients in the control group will be given no application will be made. Liquid petroleum jelly and olive oil group before the study training will be given and they will massage the recommended product twice a day for 3 months and will be asked to record them. The data obtained at the end of the project will be statistically analyzed and results will be presented.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Between the ages of 18-65, - With a total body burn area of less than 15% 2nd degree scald burn, - Wwhose treatment has been completed and who do not need dressing and do not have open wounds, - Who do not have any allergies, - Who can read and write, - Who do not have cognitive problems, - Who do not have communication problems, - Who live in Ankara and who volunteer to participate in the study. Exclusion Criteria: - Patients with burns on the face and neck, - Ppatients with dermatologic diseases and patients using antihistamines will not be included. - Patients who do not want to continue the study, - Who develop an allergic reaction during the follow-up period, - Who start treatment during the follow-up period due to itching, - Wwho have not applied more than 20% liquid vaseline/olive oil during the 3-month follow-up period (60 applications/30 days; more than 36 applications out of 180 applications) will be excluded from the study. |
Country | Name | City | State |
---|---|---|---|
Turkey | Ankara Bilkent City Hospital | Ankara |
Lead Sponsor | Collaborator |
---|---|
Ankara Yildirim Beyazit University |
Turkey,
Carrougher GJ, Martinez EM, McMullen KS, Fauerbach JA, Holavanahalli RK, Herndon DN, Wiechman SA, Engrav LH, Gibran NS. Pruritus in adult burn survivors: postburn prevalence and risk factors associated with increased intensity. J Burn Care Res. 2013 Jan-Feb;34(1):94-101. doi: 10.1097/BCR.0b013e3182644c25. — View Citation
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Reich A, Bozek A, Janiszewska K, Szepietowski JC. 12-Item Pruritus Severity Scale: Development and Validation of New Itch Severity Questionnaire. Biomed Res Int. 2017;2017:3896423. doi: 10.1155/2017/3896423. Epub 2017 Oct 2. — View Citation
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Xiao Y, Sun Y, Zhu B, Wang K, Liang P, Liu W, Fu J, Zheng S, Xiao S, Xia Z. Risk factors for hypertrophic burn scar pain, pruritus, and paresthesia development. Wound Repair Regen. 2018 Mar;26(2):172-181. doi: 10.1111/wrr.12637. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 12-item itch scale scores | assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases. |
One month after starting liquid vaseline application | |
Other | Patient scar assessment scale score | assessment of hypertrophic scar. Patient Scar Assessment Scale, 1 being "normal skin", 10 being "worst scar". shows the evaluation. The lowest score a patient can get on the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. The general opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated. | One month after starting liquid vaseline application | |
Other | Observer scar assessment scale score | assessment of hypertrophic scar. Observer Scar Assessment Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60. It represents the worst scar imaginable. |
One month after starting liquid vaseline application | |
Other | 12-item itch scale scores | assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases. |
One month after starting extra virgin olive oil application | |
Other | Patient scar assesment scale score | assessment of hypertrophic scar. Patient scar assessment scale,1 being "normal skin", 10 being "worst scar".
shows the evaluation. The lowest score a patient can get from the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. General opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated. |
One month after starting extra virgin olive oil application | |
Other | Observer scar assesment scale score | assessment of hypertrophic scar. Observer Scar Assessment Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60. It represents the worst scar imaginable. |
One month after starting extra virgin olive oil | |
Other | 12-item itch scale scores | assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases. |
control group will be applied in the first month | |
Other | Patient scar assesment scale score | assessment of hypertrophic scar. Patient Scar Assessment Scale, 1 being "normal skin", 10 being "worst scar". shows the evaluation. The lowest score a patient can get on the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. The general opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated. | control group will be applied in the first month | |
Other | Observer scar assesment scale score | assessment of hypertrophic scar. Observer Scar Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60. It represents the worst scar imaginable. |
control group will be applied in the first month | |
Other | 12-item itch scale scores | assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases. |
Two month after starting liquid vaseline application | |
Other | Patient scar assesment scale score | assessment of hypertrophic scar. Patient scar assessment scale,1 being "normal skin", and 10 being "worst scar".
shows the evaluation. The lowest score a patient can get on the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. The general opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated. |
Two month after starting liquid vaseline application | |
Other | Observer scar assesment scale score | assessment of hypertrophic scar. Observer Scar Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60. It represents the worst scar imaginable. |
Two month after starting liquid vaseline application | |
Other | 12-item itch scale scores | assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases. |
Two month after starting extra virgin olive oil application | |
Other | Patient scar assesment scale score | assessment of hypertrophic scar. Patient Scar Assessment Scale, 1 being "normal skin", 10 being "worst scar". shows the evaluation. The lowest score a patient can get on the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. The general opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated. | Two month after starting extra virgin olive oil application | |
Other | Observer scar assesment scale score | assessment of hypertrophic scar. Observer Scar Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60. It represents the worst scar imaginable. |
Two month after starting extra virgin olive oil application | |
Other | 12-item itch scale scores | assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases. |
The control group will be applied in the second month | |
Other | Patient scar assesment scale score | assessment of hypertrophic scar. Patient scar assessment scale, 1 being "normal skin", and 10 being "worst scar".
shows the evaluation. The lowest score a patient can get on the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. The general opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated. |
The control group will be applied in the second month | |
Other | Observer scar assesment scale score | assessment of hypertrophic scar. Observer Scar Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60. It represents the worst scar imaginable. |
The control group will be applied in the second month | |
Other | 12-item itch scale scores | assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases. |
Three month after starting liquid vaseline application | |
Other | Patient scar assesment scale score | assessment of hypertrophic scar. Patient Scar Assessment Scale, 1 being "normal skin", 10 being "worst scar". shows the evaluation. The lowest score a patient can get from the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. General opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated. | Three month after starting liquid vaseline application | |
Other | Oobserver scar assesment scale score | assessment of hypertrophic scar. Observer Scar Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60. It represents the worst scar imaginable. |
Three month after starting liquid vaseline application | |
Other | 12-item itch scale scores | assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases. |
Three month after starting extra virgin olive oil application | |
Other | Patient scar assesment scale score | assessment of hypertrophic scar. Patient Scar Assessment Scale, 1 being "normal skin", 10 being "worst scar". shows the evaluation. The lowest score a patient can get from the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. General opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated. | Three month after starting extra virgin olive oil application | |
Other | Observer scar assesment scale score | assessment of hypertrophic scar. Observer Scar Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60. It represents the worst scar imaginable. |
Three month after starting extra virgin olive oil application | |
Other | 12-item itch scale scores | assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases. |
The control group will be applied in the third month | |
Other | Patient scar assesment scale score | assessment of hypertrophic scar. Patient Scar Assessment Scale, 1 being "normal skin", 10 being "worst scar". shows the evaluation. The lowest score a patient can get on the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. The general opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated. | The control group will be applied in the third month | |
Other | Observer scar assesment scale score | assessment of hypertrophic scar. Observer Scar Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60. It represents the worst scar imaginable. |
The control group will be applied in the third month | |
Primary | 12-item itch scale scores | assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases. |
Before you start applying liquid vaseline | |
Primary | Observer scar assesment scale score | assessment of hypertrophic scar.Observer Scar Assessment Scale, Each item is scored on a Likert-type scale between 1 and 10. has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60.
It represents the worst scar imaginable. |
Before you start applying liquid vaseline | |
Primary | 12-item itch scale scores | assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases. |
Before you start applying extra virgin olive oil | |
Primary | Patient scar assesment scale score | assessment of hypertrophic scar. Patient Scar Assessment Scale, 1 being "normal skin", 10 being "worst scar".
shows the evaluation. The lowest score a patient can get on the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. The general opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated. |
Before you start applying extra virgin olive oil | |
Primary | Observer scar assesment scale score | assessment of hypertrophic scar. Observer Scar Assessment Scale, Each item is scored on a Likert-type scale between 1 and 10. has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60.
It represents the worst scar imaginable. |
Before you start applying extra virgin olive oil | |
Primary | 12-item itch scale scores | assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases. Assessment Scale, scar evaluation (vascularization, pigmentation, thickness, irregularity, elasticity, surface area) and scar A total of 7 articles, including 1 article evaluating the general opinion about is formed. Each item is scored on a Likert-type scale between 1 and 10. has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin, and the highest score is 60. It represents the worst scar imaginable, and the scale score is based on the first 6 items. was being calculated |
will be applied to the control group on the first day | |
Primary | Patient scar assessment scale score | assessment of hypertrophic scar. Patient Scar Assessment Scale, 1 being "normal skin", 10 being "worst scar". shows the evaluation. The lowest score a patient can get on the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. The general opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated. | will be applied to the control group on the first day | |
Primary | Observer scar assesment scale score | assessment of hypertrophic scar. Observer Scar Assessment Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin, and the highest score is 60. It represents the worst scar imaginable. |
will be applied to the control group on the first day | |
Primary | Patient scar assesment scale score | assessment of hypertrophic scar. Patient Scar Assessment Scale, 1 being "normal skin", 10 being "worst scar".
shows the evaluation. The lowest score a patient can get on the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. The general opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated. |
Before you start applying liquid vaseline | |
Secondary | 12-item itch scale scores | assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases. |
15 days after starting liquid vaseline application | |
Secondary | Patient scar assesment scale score | assessment of hypertrophic scar. Patient Scar Assessment Scale, 1 being "normal skin", 10 being "worst scar". shows the evaluation. The lowest score a patient can get on the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. The general opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated. | 15 days after starting liquid vaseline application | |
Secondary | Observer scar assesment scale score | assessment of hypertrophic scar. Observer Scar Assessment Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60. It represents the worst scar imaginable. |
15 days after starting liquid vaseline application | |
Secondary | 12-item itch scale scores | assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases. |
15 days after starting extra virgin olive oil | |
Secondary | Patient scar assesment scale score | assessment of hypertrophic scar. Patient Scar Assessment Scale, 1 being "normal skin", 10 being "worst scar". shows the evaluation. The lowest score a patient can get on the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. The general opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated. | 15 days after starting extra virgin olive oil | |
Secondary | Observer scar assessment scale score | assessment of hypertrophic scar. Observer Scar Assessment Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60. It represents the worst scar imaginable. |
15 days after starting extra virgin olive oil | |
Secondary | 12-item itch scale scores | assessment of itching severity. The lowest score on the scale is 3, indicating minimum itching, while the lowest score on the scale is 3.
The high score of 22 points indicates severe itching. Scale scores It is assumed that as the score increases, the patient's level of exposure to itching increases |
control group will be applied on the 15th day | |
Secondary | Patient scar assessment scale score | assessment of hypertrophic scar. Patient Scar Assessment Scale, 1 being "normal skin", 10 being "worst scar". shows the evaluation. The lowest score a patient can get on the scale is 6, Normal skin, the highest score of 60, the worst imaginable scar, The scale score is calculated based on the first 6 items. The general opinion about scar The 7th item, which questions questions, has only scoring criteria and is evaluated. | control group will be applied on the 15th day | |
Secondary | Observer scar assessment scale score | assessment of hypertrophic scar. Observer Scar Assessment Scale, each item is scored on a Likert-type scale between 1 and 10.
has. 1 indicates "normal skin" and 10 indicates "worst scar evaluation". The lowest score a patient can get on the scale is 6, indicating normal skin and the highest score is 60. It represents the worst scar imaginable. |
control group will be applied on the 15th day |
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