The Effect of Cold Gel Pack Application on Itching in Burn Patients in the Maturation Stage

Burns Clinical Trial

Official title:

The Effect of Cold Gel Pack Application on Itching in Burn Patients in the Maturation Stage: A Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06334679
• Other study ID #: zeynepersoz
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: December 15, 2024

Study information

• Verified date: March 2024
• Source: Marmara University
• Contact: Zeynep Ersoz
• Phone: 05553496718
• Email: zeynepersoz08[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Burn is a serious trauma that causes acute damage to the skin and subcutaneous tissues due to the effect of heat, electricity, radiation, physical, and chemical substances. It has been reported that the incidence of itching is high in burn patients during the maturation stage of wound healing. The literature suggests that in managing the symptom of itching, skin hydration support along with cold application methods can also be used. The integrity of the skin, the duration, frequency, characteristics, areas of itching, and identifying conditions that increase or decrease itching are important for managing itching. This study is planned to be conducted with a randomized controlled design to examine the effect of applying cold gel packs to burn areas of burn patients during the maturation stage on itching. This researcher's hypothesis is that burn patients who applied cold gel packs to burn areas during the maturation phase had lower itching severity (frequency, duration, intensity) than those who did not.

Description:

Patients will be assigned to one of two groups according to the block randomization list, given a sequence number according to the date and time of admission. In addition to the clinical routine application, cold gel pack application will be applied to the patients in Group 1, and the clinical routine application will continue for those in Group 2. To collect data, the Patient Diagnosis Form developed by the researcher in line with literature information, the Visual Analog Scale for Itching, the Bates-Jensen Wound Assessment Tool and the 12-Item Itching Severity Scale, whose validity and reliability analysis has been conducted, will be used. Calculation of the sample size of the study was made with the G.Power (v3.1.7) computer program. In the study of Joo et al., a total of 26 patient samples were used to represent the universe, assuming that the difference in two independent groups was considered statistically significant according to the itching degree averages of burn patients (α = 0.05 significance level and 95% power). During the research process, it was decided to include a total of 60 individuals in the sample, with 30 patients in Group-1 (Experiment) and 30 patients in Group-2 (Control), taking into account possible losses.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 15, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Burn percentage is between 15-25% and 1st or 2nd degree burn areas are in the maturation phase (BatesJensen Wound Assessment Tool Scale score=1-13),
• Describing itching in burn wounds in the last 24 hours,
• Over 18 years of age,
• Literate,
• Oriented to person, place and time,
• Having no vision, speech or communication problems,
• Do not have any skin disease other than burns,
• Patients whose vital signs are within physiological limits (Pulse: 60-100/min, Temperature: average 37 degrees Celsius, respiration 12-16/min, Blood Pressure: average 120/80).

Exclusion Criteria:

• Cold sensitivity/allergy,
• Perineum, neck and inner wrist burn areas
• Hypertrophic scar area,
• Burn infection
• Raynaud's disease,
• Use of aspirin, anticoagulants, non-steriod anti-inflammatory drugs,
• Evitamin and vasoactive agent use,
• Peripheral vascular disease,
• Connective tissue disease,
• Diabetic neuropathy,
• Use of a medication that will cause itching,
• Patients participating in another study conducted at the clinic
• Applying medical treatment in addition to the clinical routine due to itching,
• Due to the fact that he was discharged in a shorter period of time than the average hospitalization day, the research process failure to complete,
• Failure to comply with the monitoring process and conditions of the research,
• It was determined as the person wanting to leave the study voluntarily.

Related Conditions & MeSH terms

• Burns
• Pruritus

Intervention

Other:
• Cold Gel Packet Application
Cold gel packs will be placed on the burn areas of the patients in the maturation phase and applied for 20 minutes.

Locations

Country	Name	City	State
Turkey	Kartal Dr.Lütfi Kirdar City Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Joo SY, Kim JB, Cho YS, Cho YS, Seo CH. Effect of cold pack therapy for management of burn scar pruritus: A pilot study. Burns. 2018 Jun;44(4):1005-1010. doi: 10.1016/j.burns.2018.01.011. Epub 2018 Feb 13. — View Citation

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

Stander S, Augustin M, Reich A, Blome C, Ebata T, Phan NQ, Szepietowski JC; International Forum for the Study of Itch Special Interest Group Scoring Itch in Clinical Trials. Pruritus assessment in clinical trials: consensus recommendations from the Intern — View Citation

Stepien K, Reich A. The 12-Item Pruritus Severity Scale - Determining the Severity Bands. Front Med (Lausanne). 2020 Dec 17;7:614005. doi: 10.3389/fmed.2020.614005. eCollection 2020. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Itching severity	The scale consists of 12 questions. Questions 2, 3, 4, 5, 6, 7, 8 and 12 in the scale have two options, "yes" and "no", and the scoring changes as 1 or 0. The frequency of itching in the first question and itchy areas in the 11th question are marked and scored between 1 and 3. The 9th question, which evaluates the frequency of waking up from sleep due to itching, has 4 items and is scored between 0-3. The 10th question, which evaluates the severity of itching, has 5 items and is scored between 1-5. The score obtained from the scale is at least 3 and at most 22, and as the score increases, the level of being affected by itching also increases. Scores obtained as a result of the scale indicate mild itching between "3-6", moderate itching between "7-11" and severe itching between "12-22".	The itching severity of the patients was measured with the "12-Item Itching Severity Scale"; Before the first application, it will be evaluated a total of 5 times over 4 days, on the morning of the next day of application.
Primary	Itching grade	Visual Analog Scale (VAS).It is stated that Visual Analogue Scale (VAS) can be used to measure the severity of itching. VAS is a numerical and one-dimensional scale and is mostly used to obtain an objective result by evaluating the intensity and severity of itching. The scale is scored between 1-10. VAS is a scale that initially ranges from 0 "I have no itching" to 10 "I have very severe itching", with each interval corresponding to one centimeter and given a numerical value. On the scale, 0 points indicate no itching, 1-3 points indicate mild itching, 4-6 points indicate moderate itching, 7-8 points indicate severe itching, and 9 and above points indicate very severe itching.	itching grade will be evaluated instantly with the Visual Analog Scale (VAS) 0 minutes before each application and 20 minutes immediately after the application.The scale will be evaluated for 4 days with repeated measurements twice a day before and after