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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06076031
Other study ID # IRB2023051
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 30, 2023
Est. completion date September 1, 2024

Study information

Verified date October 2023
Source Chiayi Christian Hospital
Contact Chun-Man Pan
Phone 05-2765041
Email cych06121@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

During the acute phase of burn injuries, the focus for patients is primarily on wound pain and infection care. Patients often describe the pain during dressing changes as a sharp, stabbing sensation. Pain is a distressing experience for burn injury patients, affecting both their physical and mental well-being, as well as influencing wound healing. The pain caused by dressing changes is a significant issue that leads to physical and emotional suffering for patients.


Description:

Background: During the acute phase of burn injuries, the focus for patients is primarily on wound pain and infection care. In this stage of treatment, frequent dressing changes are necessary, with some wounds requiring daily cleansing to promote healing and prevent infection. Patients often describe the pain during dressing changes as a sharp, stabbing sensation. Pain is a distressing experience for burn injury patients, affecting both their physical and mental well-being, as well as influencing wound healing. The pain caused by dressing changes is a significant issue that leads to physical and emotional suffering for patients. Objective: The aim of this study is to conduct a cross-over randomized clinical trial to compare the effects of with using streaming media (video and audio) on reducing pain medication use, anxiety, pain intensity, and factors related to pain during dressing changes for second-degree burn patients. Methods: This study plans to utilize a cross-over randomized clinical trial design with patients from the burn injury ward of a regional teaching hospital in Chiayi. Research instruments include demographic characteristics, disease information, Burn Pain Anxiety Scale, Numerical Pain Scale, and vital signs. Statistical methods will encompass descriptive statistics, independent samples t-test, chi-square test, generalized estimating equations, and multiple linear regression to identify the effectiveness of streaming media usage during dressing changes for second-degree burn patients in reducing pain medication use and anxiety, as well as related factors. Expected outcomes: It is anticipated that the use of streaming media during dressing changes for second-degree burn patients will lead to reduced pain medication use, anxiety, and related factors. The results of this study can provide evidence for the intervention of using streaming media to alleviate dressing change pain effectively during the care of second-degree burn patients, thereby enhancing the quality of pain care.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date September 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: - Must stay in the burn ward for 2 days - Have clear consciousness - Aged 20 years old (inclusive) and above superior - Patients with superficial 2 degree burns accounting for 10% of the body surface area or deep 2 degree burns accounting for 5% of the body surface area were diagnosed by physicians - Can communicate in Chinese and Taiwanese and agree to participate in this study Exclusion Criteria: - Mental disease. - Cognitive impairment. - Visual and hearing impairment.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Streaming Media
The aim of this study is to conduct a cross-over randomized clinical trial to compare the effects of with using streaming media (video and audio) on reducing pain medication use, anxiety, pain intensity, and factors related to pain during dressing changes for second-degree burn patients.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chiayi Christian Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Numerical Rating Scale (NRS) : 0 means no pain, and 10 means very painful. The intensity of pain 30 minutes before the dressing change
The intensity of pain when starting the dressing change (remove gauze)
The intensity of pain when at the dressing change (washing the wound)
The intensity of pain when at the end of the dressing change (the dressing is wrapped)
The intensity of pain 30 minutes after the dressing change
one year
Primary Burns Specific Pain Anxiety Scale (BSPAS) : 0 represents not anxious, and 10 represents very anxious The intensity of anxiety 30 minutes before the dressing change
The intensity of anxiety 30 minutes after the dressing change
one year
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