Effectiveness of Nonpharmacologic Therapies on Pain After Removal of Chest Drains in Postoperative Cardiac Surgery, Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Measurement of patient-reported pain using the visual numerical pain scale.
研究概览
简要总结
The objective of this clinical trial is to determine the effectiveness of pain reduction between an experimental treatment and the usual one when removing thoracic drains in post cardiac surgery patients, in a Cardiovascular Critical Patient Unit, in Temuco, between the years 2024- 2026. Its safety will also be analyzed. The main questions to be answered are:
- What is the effectiveness of non-pharmacological therapies in reducing pain in the removal of chest drains in post-operated patient of cardiac surgery, in Cardiovascular Critical Patient Unit, Temuco, between the years 2024- 2026?
Participants:
- Two non-pharmacological therapies will be applied, to one group aromatherapy with lavender essential oils, which were previously submitted to oil property analysis. And another group with local cold therapy, there will also be a control group with the usual pharmacological therapy.
- All the groups will receive the usual pharmacological treatment, the non pharmacological therapies will only be of support, in no case they will replace the usual medical therapy.
详细描述
Controlled clinical trial, randomized, single-blind, with a sample of 100 postoperative cardiac surgery patients who meet inclusion and exclusion criteria. The sample will be obtained by two nurses with more than 8 years of experience in cardiac intensive care and specializations, of these patients all will receive the usual pharmacological therapy, will be divided into three groups: 25 patients (local cold); 25 patients (aromatherapy); 50 patients (with usual pharmacological therapy, indicated by medical team, without adding TNF). Data will be collected through a form. The database will be exported to STATA CORP18 software, where they will be analyzed. The ethical requirements of Ezequiel Emanuel will be considered.
Translated with DeepL.com (free version)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Postoperative cardiac surgery patient with indication of the cardiac surgeon to remove chest drains within the first 24 hours postoperatively.
- •Patient who follows orders and with vigil state of consciousness, temporally and spatially oriented.
- •Usual analgesic treatment indicated by physician: paracetamol 1 g every 8 hours; or Metamizole 1 g every 8 hours; Ketoprofen every 8 hours, or pregabalin 75 mg every 24 hours, last administration at 07:00 am.
- •INR < 2.5; Platelets > 50,000.
排除标准
- •Patient with psychomotor agitation
- •Dependence on psychotropic drugs, alcohol, or with abstinence syndrome.
- •Patient in postoperative course with cardiogenic shock, with need for 2 or more vasoactive drugs (VAD).
- •Older than 80 years old.
- •Maintained with continuous infusion pump (CIB) of analgesia.
- •Refractory pain, with second line management: Lidocaine patches, Buprenorphine patches, Patient controlled analgesia pump.
- •Administration of anticoagulant at 07:00 am.
研究组 & 干预措施
Local cold application group
patients with indication for removal of drains after cardiac surgery, with analgesia according to the protocol indicated by the resident physician, to whom local cold will be applied . If after the removal of drains there is pain that does not subside with complementary therapy, extra analgesia may be requested.
干预措施: Local cold therapy. (Other)
Aromatherapy group
Patients with indication for removal of drains after cardiac surgery, with analgesia according to protocol indicated by resident physician, who at the time of removal of drains will be applied aromatherapy with lavender oil. If after the removal of drains has a pain that does not subside, with complementary therapy, you can request extra analgesia.
干预措施: Lavender oil. (Other)
Control group.
Patients with indication for removal of drains after cardiac surgery, with analgesia according to the protocol indicated by the resident physician, the routine technique will be performed.
结局指标
主要结局
Measurement of patient-reported pain using the visual numerical pain scale.
时间窗: Pain measurement at 5, 10 and 20 minutes after drain removal.
Pain measurement at 5, 10 and 20 minutes after drain removal. For quantification of pain using the visual numerical pain scale. it was divided into mild 1 -3 , moderate 4-6 and severe 7-10. It is necessary for the patient to understand the meaning and content of the scale, for which reason the patient must be in adequate cognitive condition to guarantee his or her ability to collaborate.
次要结局
未报告次要终点
研究者
Greys Kasandra Kasandra González González
Msc.
Universidad de La Frontera