The Effect of Cold and Arm Sling Elevation Pillow on Postoperative Anxiety and Comfort in Pediatric Upper Extremity Fractures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Comfort
研究概览
简要总结
The purpose of this clinical trial is to learn whether the use of a "cold and arm sling elevation pillow" affects anxiety and comfort levels in children aged 7-12 years undergoing surgery for upper extremity fractures. The main questions it aims to answer are:
- Does the use of a cold and arm sling elevation pillow reduce postoperative anxiety levels in children?
- Does the use of a cold and arm sling elevation pillow increase postoperative comfort levels in children?
Researchers will compare the experimental group (using the specially designed cold and arm sling elevation pillow) with the control group (receiving standard clinical care, including standard pillows and separate ice packs) to see the effects of the integrated pillow on anxiety and comfort.
Participants will:
- Receive education before surgery based on their randomly assigned group (experimental or control),
- Use the assigned elevation and cold application method for the first 24 hours following surgery,
- Complete anxiety and comfort assessment scales at four different time points: before the intervention, just before surgery, 6 hours after surgery, and at the time of discharge.
详细描述
Experimental Arm
- Intervention Name: Cold and Arm Sling Elevation Pillow
- Description: A multi-functional device based on Kolcaba's Comfort Theory that integrates three components:
- Elevation Module: Maintains the limb above heart level to reduce postoperative edema.
- Cold Application Module: Waterproof sleeve with velcro fasteners for intermittent cold gel pack application (15-20 minutes per hour for the first 24 hours).
- Arm Sling Function: Adjustable straps allow the pillow to function as a stabilizer during mobilization. The device features a child-friendly "teddy bear" design to reduce medical anxiety.
Active Comparator Arm
- Intervention Name: Standard Clinical Care
- Description: Routine postoperative care according to hospital protocol, including:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
To ensure the objectivity of the study findings, a single-blind design is employed. While the participants and investigators are aware of the intervention due to its physical nature, the data collector (outcome assessor) is a clinical nurse who is blinded to the group assignments of the children. This assessor performs the observations and administers the scales (STAIC and CCBC) without knowledge of whether the child is in the experimental or control group.
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 7-12 years
- •Scheduled for elective surgery with a diagnosis of upper extremity fracture
- •Planned to receive analgesic treatment every 8 hours (three times daily) for postoperative pain management
- •Fully oriented and without any condition that would impair communication or cooperation
- •Expected to have a hospital stay of at least 24 hours in the orthopedic wards where the study is conducted
- •Children and their parents/legal guardians who provide consent to participate in the study
排除标准
- •Undergoing emergency surgical intervention
- •Presence of an open wound, infection, suspected compartment syndrome, or vascular injury at the fracture site
- •Presence of sensory loss or neurological deficit in the affected extremity
- •Presence of cognitive, hearing, speech, or severe physical disabilities
- •Treated conservatively with cast immobilization
- •Planned postoperative analgesic regimens that are more frequent or less frequent than every 8 hours, or that require high-dose analgesic therapy
- •Requiring revision surgery
- •Presence of metabolic or neuromuscular comorbidities (e.g., osteogenesis imperfecta, recurrent fractures)
- •Children whose mothers are unable to communicate or do not speak Turkish
研究组 & 干预措施
Control Group
Participants in this group will receive standard postoperative nursing care as per the hospital's routine protocol. This includes elevation of the affected extremity using a standard pillow, cold application using ice gel packs wrapped in gauze, and the use of a standard arm sling during mobilization.
干预措施: Standard postoperative care (Other)
Cold and arm sling elevation pillow group
Participants in this group will receive the 'Cold and Arm Sling Elevation Pillow' intervention. This specially designed supportive device integrates three functions: cold application, limb elevation, and arm sling support. The intervention will be applied in the postoperative period to improve patient comfort and reduce anxiety levels
干预措施: Cold and arm sling elevation pillow (Device)
结局指标
主要结局
Comfort
时间窗: Measurements will begin one day before surgery and continue on the morning of surgery in the preoperative period. Postoperative measurements will be conducted at 6 hours after surgery and on the first postoperative day prior to discharge.
Comfort will be assessed using the Child Comfort Behavior Checklist. The scale consists of five sub-dimensions ("Vocalizations," "Motor Symptoms," "Performance," "Facial Expressions," and "Other") with a total of 30 items. Items are scored on a 5-point Likert-type scale, ranging from 0 to 4 (Not applicable=0, None=1, Slightly=2, Moderate=3, Strong=4). During the scoring phase, items scored as "0" (not applicable to the child's age or condition) are excluded from the total score calculation. The child's actual score is determined by dividing the total points by the potential maximum score achievable for that specific child. The maximum possible score for the scale is 100, where higher scores indicate higher levels of comfort (a more positive outcome).
Postoperative anxiety
时间窗: Measurements will begin one day before surgery and continue on the morning of surgery in the preoperative period. Postoperative measurements will be conducted at 6 hours after surgery and on the first postoperative day prior to discharge.
State anxiety will be assessed using the State-Trait Anxiety Inventory for Children (STAI-C). Reverse-scored items will be scored according to standard scoring guidelines, with total scores ranging from 20 to 60, where higher scores indicate higher levels of state anxiety (representing a more negative outcome).
次要结局
未报告次要终点
研究者
İlke Karabıyık Demir
Clinical Nurse Specialist (Phd Stutdent - Doctoral Candidate)
Istanbul University - Cerrahpasa