Effect of Fan-Assisted Local Cooling on Pain During Intravenous Cannulation in Adults: A Prospective, Crossover, Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain intensity during intravenous cannulation
研究概览
简要总结
Inserting an intravenous (IV) cannula is one of the most frequently performed procedures in clinical practice, and it is commonly experienced as painful. Before the needle is inserted, the skin is routinely cleaned with alcohol. As alcohol evaporates it cools the skin, and cooled skin is less sensitive to pain. This study examined whether accelerating that evaporation with a simple portable hand fan reduces the pain of IV cannulation.
One hundred volunteers aged 18 to 65 years who required elective IV cannulation took part in the emergency department of a tertiary care city hospital. Each participant underwent two cannulations, one in each arm, within a single session. On one arm the skin was prepared with 70% isopropyl alcohol in the usual way. On the other arm the same alcohol was applied and the site was then fanned for 15 seconds with a portable hand fan before the needle was inserted. The order of the two arms was assigned randomly, so each participant served as their own comparison.
Within 30 seconds of each cannulation, participants rated their pain on a 0 to 10 numeric scale. The assessor who recorded these scores did not know which arm had received the fan. The researchers also recorded whether the vein was entered on the first attempt, any skin irritation at 5 and 30 minutes, and, after both cannulations were completed, how satisfied participants were with the fan-assisted method.
The purpose of the study was to determine whether this low-cost, drug-free method can make IV cannulation less painful without making it harder to place the cannula.
详细描述
A pre-planned pilot substudy was conducted under the same ethics committee approval in an independent sample of 20 adult volunteers who were not enrolled in the main trial. Antecubital skin temperature was measured with a non-contact infrared thermometer held at a fixed distance of 3 cm, immediately before and immediately after the 15-second fan-assisted alcohol application, to verify that the intervention produces the evaporative cooling proposed as its analgesic mechanism.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding of participants and the operator was not possible owing to the nature of the intervention. The assessor who recorded outcome measures was blinded to which arm was the intervention arm.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 65 years
- •Scheduled peripheral intravenous cannulation at the antecubital region
- •Written informed consent provided
排除标准
- •Severe peripheral vascular disease (chronic venous insufficiency or history of thrombophlebitis)
- •Alcohol intolerance or allergy
- •Active dermatological disease (eczema, psoriasis, contact dermatitis)
- •Neuropathic disease that may alter pain perception
- •Analgesic use within the previous 6 hours
- •Existing pain with NRS score of 4 or higher
- •Refusal to provide consent
研究组 & 干预措施
Sequence B: Standard preparation first
Participants randomised to the BA sequence first underwent intravenous cannulation on the right arm with standard alcohol preparation alone, and then underwent cannulation on the left arm, where the site was prepared with 70% isopropyl alcohol followed by 15 seconds of fan-assisted local cooling. A minimum washout period of 5 minutes separated the two cannulations.
干预措施: Fan-assisted local cooling (Other)
Sequence A: Fan-assisted cooling first
Participants randomised to the AB sequence first underwent intravenous cannulation on the right arm, where the site was prepared with 70% isopropyl alcohol followed by 15 seconds of fan-assisted local cooling, and then underwent cannulation on the left arm with standard alcohol preparation alone. A minimum washout period of 5 minutes separated the two cannulations.
干预措施: Fan-assisted local cooling (Other)
Sequence A: Fan-assisted cooling first
Participants randomised to the AB sequence first underwent intravenous cannulation on the right arm, where the site was prepared with 70% isopropyl alcohol followed by 15 seconds of fan-assisted local cooling, and then underwent cannulation on the left arm with standard alcohol preparation alone. A minimum washout period of 5 minutes separated the two cannulations.
干预措施: Standard alcohol skin preparation (Other)
Sequence B: Standard preparation first
Participants randomised to the BA sequence first underwent intravenous cannulation on the right arm with standard alcohol preparation alone, and then underwent cannulation on the left arm, where the site was prepared with 70% isopropyl alcohol followed by 15 seconds of fan-assisted local cooling. A minimum washout period of 5 minutes separated the two cannulations.
干预措施: Standard alcohol skin preparation (Other)
结局指标
主要结局
Pain intensity during intravenous cannulation
时间窗: Within 30 seconds after completion of each cannulation
Self-reported pain intensity during needle insertion, measured with the Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain. Each participant provided one score for the fan-assisted arm and one score for the standard preparation arm.
Pain intensity during intravenous cannulation
时间窗: Day 1: within 30 seconds after completion of each cannulation
Self-reported pain intensity during needle insertion, measured with the Numeric Rating Scale (NRS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain. Each participant provided one score for the fan-assisted arm and one score for the standard preparation arm.
次要结局
- First-attempt cannulation success(At the time of cannulation)
- Skin irritation at the cannulation site(5 minutes and 30 minutes after cannulation)
- Participant satisfaction with the procedure(Once, after both cannulations had been completed)
- First-attempt cannulation success(Day 1: at the time of each cannulation attempt)
- Skin irritation at the cannulation site(Day 1: 5 minutes and 30 minutes after cannulation)
- Participant satisfaction with the procedure(Day 1: immediately after completion of both cannulations)