Pain ManagementNPTNCT06974071
Effectiveness of Nonpharmacologic Therapies on Pain After Removal of Chest Drains in Postoperative Cardiac Surgery
A study testing Local cold therapy. and Lavender oil. in people with Pain Management, run by Universidad de La Frontera at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Pain Management
- What is being tested?
- Local cold therapy. and Lavender oil.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChile
- Study dates
- 20 Apr 2025to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Nonpharmacologic Therapies on Pain After Removal of Chest Drains in Postoperative Cardiac Surgery, Study Protocol
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?
Read more
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.
Read the detailed description
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)
- Conditions
- Pain Management
- Being tested
- Local cold therapy., Lavender oil.
- Keywords
- cardiac surgery, pain management, chest drain, non-pharmacological therapy
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local cold therapy.Other
It will be applied by means of a refrigerated unit based on gel pack, these units will be stored in the refrigerator of the Unit, which is kept between 2 - 6 degrees, the application protocol is described in Annex B, this was reviewed in conjunction with quality nurses of the Cardiovascular Unit, to avoid biases.
Lavender oil.Other
Lavender essential oil will be used by applying 5 drops in a sterile dressing 15x15 which will be placed on the side of the patient's bedside at 10 cm from the patient.
To maintain the safety of the patients and ensure the quality of the products, two essential oils will be chosen, certified by the Institute of Public Health (ISP), the first one "Lavender essential oil, body and aromatherapy use" of the Weleda brand, with sanitary authorization N° 154C-15 and the essential oil Doterra, sanitary authorization N° 2832C-6/21, with authorization by the Food and Drugs Administration (FDA), in charge of ensuring the quality of substances that are marketed from the United States to the rest of the world.
These oils will be subjected to a characterization process, choosing the one with the highest quality and purity, through the protocol sent by the Scientific and Technological Nucleus in Bioresources (BioRen), which are specified in section 5.10.
| Study group | Role | What they receive |
|---|---|---|
| Local cold application group | Experimental | 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. Receives: Other: Local cold therapy. |
| Aromatherapy group | Experimental | 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. Receives: Other: Lavender oil. |
| Control group. | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of patient-reported pain using the visual numerical pain scale.
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.
Measured: Pain measurement at 5, 10 and 20 minutes after drain removal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start20 Apr 2025
- Primary completion20 Sep 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Specific treatment protocol for each group. The procedures will be performed by two nurses who are part of the research, as co-investigators and project assistants, being clinical nurses of the Unit, the procedures to be performed will be assisted by Senior Nursing Technicians (TENS) on duty. This will be performed between 11:00 - 13:00, at a time to be agreed upon by the nurses, this time is preferred because of the time difference with the administration of usual analgesic treatment. The nurses do not need separate training in drain removal due to experience in the area, and the recent refresher course in the management of chest drains, and the drain removal protocol in which they participated as authors. * Usual treatment: Patients with indication for drainage removal after cardiac surgery, with analgesia according to the protocol indicated by the resident physician, the routine technique will be performed. * Experimental treatment with
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de La Frontera
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Greys Kasandra Kasandra González González, Universidad de La Frontera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06974071
- Sponsor's protocol ID
- DIM24-0009
- Other IDs
- DIM24-0009
- Acronym
- NPT
- Status last verified
- May 2025
- First submitted
- 7 May 2025
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Under no circumstances will personal information of the enrolled subjects be shared, data such as: * Ages. * Pain assessment. * Gender. * Type of surgery. * Number of drains.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Nonpharmacologic Therapies on Pain After Removal of Chest Drains in Postoperative Cardiac Surgery, Study Protocol
- ClinicalTrials.gov ID
- NCT06974071
- Acronym / sponsor ID
- NPT / DIM24-0009
- Conditions
- Pain Management
- Keywords
- cardiac surgery, pain management, chest drain, non-pharmacological therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad de La FronteraUniversity, hospital or other
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 15 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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)
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- * Specific treatment protocol for each group. The procedures will be performed by two nurses who are part of the research, as co-investigators and project assistants, being clinical nurses of the Unit, the procedures to be performed will be assisted by Senior Nursing Technicians (TENS) on duty. This will be performed between 11:00 - 13:00, at a time to be agreed upon by the nurses, this time is preferred because of the time difference with the administration of usual analgesic treatment. The nurses do not need separate training in drain removal due to experience in the area, and the recent refresher course in the management of chest drains, and the drain removal protocol in which they participated as authors. * Usual treatment: Patients with indication for drainage removal after cardiac surgery, with analgesia according to the protocol indicated by the resident physician, the routine technique will be performed. * Experimental treatment with
| Arm | Type | Receives |
|---|---|---|
| Local cold application group | Experimental | Other: Local cold therapy.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. |
| Aromatherapy group | Experimental | Other: Lavender oil.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. |
| Control group. | No intervention | –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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Local cold therapy.It will be applied by means of a refrigerated unit based on gel pack, these units will be stored in the refrigerator of the Unit, which is kept between 2 - 6 degrees, the application protocol is described in Annex B, this was reviewed in conjunction with quality nurses of the Cardiovascular Unit, to avoid biases. | Other | Local cold application group |
| Lavender oil.Lavender essential oil will be used by applying 5 drops in a sterile dressing 15x15 which will be placed on the side of the patient's bedside at 10 cm from the patient. To maintain the safety of the patients and ensure the quality of the products, two essential oils will be chosen, certified by the Institute of Public Health (ISP), the first one "Lavender essential oil, body and aromatherapy use" of the Weleda brand, with sanitary authorization N° 154C-15 and the essential oil Doterra, sanitary authorization N° 2832C-6/21, with authorization by the Food and Drugs Administration (FDA), in charge of ensuring the quality of substances that are marketed from the United States to the rest of the world. These oils will be subjected to a characterization process, choosing the one with the highest quality and purity, through the protocol sent by the Scientific and Technological Nucleus in Bioresources (BioRen), which are specified in section 5.10. | Other | Aromatherapy group |
Primary outcome
Measurement of patient-reported pain using the visual numerical pain scale.
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: Yes. Under no circumstances will personal information of the enrolled subjects be shared, data such as: * Ages. * Pain assessment. * Gender. * Type of surgery. * Number of drains.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Local cold therapy. and Lavender oil. in people with Pain Management, run by Universidad de La Frontera at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of patient-reported pain using the visual numerical pain scale. (time frame: Pain measurement at 5, 10 and 20 minutes after drain removal.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.