Investigating the Use of Music During Wound Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 11
- 主要终点
- Presence of wound pain during dressing change
研究概览
简要总结
Pressure injuries (also known as pressure wounds or bed sores) are increasingly common among older adults living in care homes. These wounds often require regular dressing changes, which can be uncomfortable for some.
The researchers believe that listening to music during wound care may have an effect on pain, wound healing, and the overall wound care experience, compared with wound care without music.
The goal of this clinical study is to test this idea by examining whether listening to music before and during wound care is linked to differences in pain, wound healing, and the overall wound care experience in older adults with pressure injuries.
The main questions this study aims to answer are:
Does listening to music before and during pressure injury care affect pain during wound care? Does listening to music before and during pressure injury care affect how pressure injuries heal over time? Does listening to music affect the overall experience of pressure injury care? Researchers will compare wound care with music to wound care without music to better understand whether music makes a difference.
The study will take place in eleven long-term care homes in Ontario. Participants will be residents aged 60 years and older who have a stage II, III, or IV pressure injury and who are already receiving regular wound care as part of their usual care. This study will not include residents who have infected or necrotic wounds, or who are at the end of life.
Participants will continue to receive the same wound care they would normally receive. Some homes will include music during wound care, and some homes will not.
Participants in homes using music will:
Listen to a playlist of music they personally enjoy for about 15 minutes before wound care begins Continue listening to the music during the wound care procedure Be able to change the volume or stop the music at any time Participants in homes not using music will receive the same standard pressure injury care without music.
Information for the study will come from clinical records that nurses already complete during routine wound care, such as notes about pain and wound healing. Staff involved in playing the music will also complete a short questionnaire about their observations of the wound care experience. Photos of wounds that are already taken as part of usual care may be reviewed to look at healing over time.
Participants may take part in the study for up to six months or until their wound has healed. Taking part is voluntary, and participants or their decision-makers can choose to stop at any time. The study does not change the medical care participants receive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
For one of the outcomes, the photo-based analysis, the outcomes assessors will be blinded. The study is otherwise not blinded.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 years or older
- •Has a stage II, III, or IV pressure injury
排除标准
- •Designated as end of life and/or has a Kennedy terminal pressure injury
- •Has an unstageable pressure injury
- •The pressure injury has necrotic tissue or necrotic bone present
- •The pressure injury is infected
- •The pressure injury is caused by a medical device in that area
- •Severe to profound hearing loss that is not corrected by a hearing aid or other assistive hearing device.
研究组 & 干预措施
Music intervention arm
Participants in this group will have their personalized playlists (i.e., based on their musical preferences) played for them ~15 minutes before and during their standard wound care. The participants can adjust the volume and/or pause the music at any time.
干预措施: Music listening (Other)
Control arm
Participants in this group will receive standard wound care.
结局指标
主要结局
Presence of wound pain during dressing change
时间窗: At each dressing change (weekly or every 2-3 days, depending on the participant), up to 6 months.
Measured as yes/no.
Frequency of wound pain during dressing changes
时间窗: At each dressing change, up to 6 months.
Measured categorically as none/intermittent/at dressing/ continuous.
次要结局
- Wound area(Measured weekly for up to 6 months.)
- Time to complete healing(Measured for up to 6 months.)
- Caregivers' perceptions(Measured weekly for up to 6 months.)
研究者
Chelsea Mackinnon
Sessional Instructor
McMaster University