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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
Chiayi Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

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

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    September 18, 2023
    Last Updated
    October 7, 2023
    Sponsor
    Chiayi Christian Hospital
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    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

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    Effects of Applying Streaming Media on Reducing Pain in Patient With Second-degree Burn During Changing Dressing

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