Effects of Applying Streaming Media on Reducing Pain in Patient With Second-degree Burn During Changing Dressing
Primary Purpose
Burns, Pain, Burning, Anxiety
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Streaming Media
Sponsored by
About this trial
This is an interventional supportive care trial for Burns focused on measuring second-degree burns, streaming, pain, anxiety, pain medication, dressing change
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Routine care
lntervention
Arm Description
Analgesic use
streaming media (video and audio) use
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT06076031
First Posted
September 18, 2023
Last Updated
October 7, 2023
Sponsor
Chiayi Christian Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06076031
Brief Title
Effects of Applying Streaming Media on Reducing Pain in Patient With Second-degree Burn During Changing Dressing
Official Title
To Investigate the Effects of Applying Streaming Media on Reducing Pain Medication, Anxiety, and Pain and Related Factors in Patient With Second-degree Burn During Changing Dressing:A Cross-over Randomization Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiayi Christian Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Pain, Burning, Anxiety
Keywords
second-degree burns, streaming, pain, anxiety, pain medication, dressing change
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Routine care
Arm Type
No Intervention
Arm Description
Analgesic use
Arm Title
lntervention
Arm Type
Experimental
Arm Description
streaming media (video and audio) use
Intervention Type
Behavioral
Intervention Name(s)
Streaming Media
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numerical Rating Scale (NRS) : 0 means no pain, and 10 means very painful.
Description
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
Time Frame
one year
Title
Burns Specific Pain Anxiety Scale (BSPAS) : 0 represents not anxious, and 10 represents very anxious
Description
The intensity of anxiety 30 minutes before the dressing change
The intensity of anxiety 30 minutes after the dressing change
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chun-Man Pan
Phone
05-2765041
Ext
7198
Email
cych06121@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jun-Yu Fan
Phone
03-2118999
Ext
5501
Email
jyfan@mail.cgust.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-Man Pan
Organizational Affiliation
Ditmanson Medical Foundation Chia-Yi Christian Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Effects of Applying Streaming Media on Reducing Pain in Patient With Second-degree Burn During Changing Dressing
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