Effectiveness of Nonpharmacologic Therapies on Pain After Removal of Chest Drains in Postoperativ… (NCT06974071) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effectiveness of Nonpharmacologic Therapies on Pain After Removal of Chest Drains in Postoperative Cardiac Surgery
Chile100 participantsStarted 2025-04-20
Plain-language summary
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.
Who can participate
Age range
20 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measurement of patient-reported pain using the visual numerical pain scale.
Timeframe: Pain measurement at 5, 10 and 20 minutes after drain removal.