The Effect of Laughie Exercise on Pain Anxiety and Pain Level in Second-Degree Burn Patients: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- 1. Burn Specific Pain Anxiety
研究概览
简要总结
Burn injuries are traumatic conditions that seriously affect individuals' quality of life, both physically and psychologically. Second-degree burns, in particular, affect the superficial and/or deep layers of the dermis, causing intense pain and extensive tissue damage. Pain in burn patients is not only physical; it combines with emotional stress, fear, and uncertainty to increase anxiety levels.
This study is a parallel group-randomised controlled trial designed to evaluate the effects of the Laughie exercise, administered prior to dressing changes in individuals diagnosed with second-degree burns, on post-dressing pain anxiety levels and pain intensity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age and over
- •Having a second degree burn
- •Arriving for the second dressing change on the unit
- •To agree to participate in the research
排除标准
- •In multiple burns, a burn degree other than the second degree on any part of the body
- •A maximum of 96 hours have elapsed since the burn injury
- •To have come to the dressing in repetitions other than the second dressing
- •Inability to tolerate the Laughie exercise
研究组 & 干预措施
Intervention Group
Laughie
干预措施: Laughie (Other)
Control Group
Control:
Second-degree burn patients. For patients presenting for their second dressing change, standard dressing change prosedures will be applied. The study procedure will include the following steps: (1) collection of descriptive characteristics; (2) assessment of pain severity and pain anxiety levels 5-10 minutes before the dressing change; (3) application of the dressing; (4) reassessment of pain severity and pain anxiety levels five minutes after the procedure.
结局指标
主要结局
1. Burn Specific Pain Anxiety
时间窗: Change from baseline scores at the end of 15 minutes.
The Burn Specific Pain Anxiety Scale (BSPAS) consists of nine items. The scale was designed to assess pain-related anxiety in patients with burn injuries. The Turkish version includes eight items, each rated on a two-ended visual analog scale ranging from 0 to 10, with anchor points defined as "none at all" (0) and "in the worst possible way" (10). Total scores are calculated by summing the item scores, yielding a possible range from 0 to 80. Higher total scores reflect greater levels of pain-related anxiety experienced by patients during painful hospital procedures. The internal consistency of the Turkish version was excellent, with a Cronbach's α coefficient of 0.95.
次要结局
- The Visual Analog Scale (VAS)(Change from baseline scores at the end of 15 minutes.)
研究者
Burcu Duluklu
Asst. Prof.
Hacettepe University