BurnsNCT06076031
Effects of Applying Streaming Media on Reducing Pain in Patient With Second-degree Burn During Changing Dressing
A study testing Streaming Media in people with Burns and Pain, Burning, run by Chiayi Christian Hospital.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Burns, Pain, Burning, Anxiety
- What is being tested?
- Streaming Media
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2023to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Mental disease.
- Cognitive impairment.
- Visual and hearing impairment.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Burns, Pain, Burning, Anxiety
- Being tested
- Streaming Media
- Keywords
- second-degree burns, streaming, pain, anxiety, pain medication, dressing change
- Medical subject headings
- Burns, Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Streaming MediaBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine care | No intervention | Analgesic use |
| lntervention | Experimental | streaming media (video and audio) use Receives: Behavioral: Streaming Media |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start30 Sep 2023 (estimated)
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiayi Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun-Man Pan, Study chair, Ditmanson Medical Foundation Chia-Yi Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076031
- Sponsor's protocol ID
- IRB2023051
- Status last verified
- Oct 2023
- First submitted
- 18 Sep 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06076031
- Acronym / sponsor ID
- IRB2023051
- Conditions
- Burns, Pain, Burning, Anxiety
- Keywords
- second-degree burns, streaming, pain, anxiety, pain medication, dressing change
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chiayi Christian HospitalUniversity, hospital or other
- Study start
- 30 Sep 2023 (estimated)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine care | No intervention | –Analgesic use |
| lntervention | Experimental | Behavioral: Streaming Mediastreaming media (video and audio) use |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Mental disease.
- Cognitive impairment.
- Visual and hearing impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Streaming MediaThe 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. | Behavioural | lntervention |
Primary outcome
Numerical Rating Scale (NRS) : 0 means no pain, and 10 means very painful.
Time frame: one year
1. The intensity of pain 30 minutes before the dressing change 2. The intensity of pain when starting the dressing change (remove gauze) 3. The intensity of pain when at the dressing change (washing the wound) 4. The intensity of pain when at the end of the dressing change (the dressing is wrapped) 5. 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
Time frame: one year
1. The intensity of anxiety 30 minutes before the dressing change 2. The intensity of anxiety 30 minutes after the dressing change
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun-Man Pan study chair
Ditmanson Medical Foundation Chia-Yi Christian Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Streaming Media in people with Burns and Pain, Burning, run by Chiayi Christian Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun-Man Pan (05-2765041 ext. 7198, cych06121@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) : 0 means no pain, and 10 means very painful. (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.