NCT06076031

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

September 30, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

October 10, 2023

Status Verified

October 1, 2023

Enrollment Period

3 months

First QC Date

September 18, 2023

Last Update Submit

October 7, 2023

Conditions

Keywords

second-degree burnsstreamingpainanxietypain medicationdressing change

Outcome Measures

Primary Outcomes (2)

  • Numerical Rating Scale (NRS) : 0 means no pain, and 10 means very painful.

    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

    one year

  • Burns Specific Pain Anxiety Scale (BSPAS) : 0 represents not anxious, and 10 represents very anxious

    1. The intensity of anxiety 30 minutes before the dressing change 2. The intensity of anxiety 30 minutes after the dressing change

    one year

Study Arms (2)

Routine care

NO INTERVENTION

Analgesic use

lntervention

EXPERIMENTAL

streaming media (video and audio) use

Behavioral: Streaming Media

Interventions

Streaming MediaBEHAVIORAL

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.

lntervention

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Mental disease.
  • Cognitive impairment.
  • Visual and hearing impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

BurnsPainAnxiety Disorders

Condition Hierarchy (Ancestors)

Wounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Chun-Man Pan

    Ditmanson Medical Foundation Chia-Yi Christian Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2023

First Posted

October 10, 2023

Study Start

September 30, 2023

Primary Completion

January 1, 2024

Study Completion

September 1, 2024

Last Updated

October 10, 2023

Record last verified: 2023-10