Effectiveness of Nonpharmacologic Therapies on Pain After Removal of Chest Drains in Postoperative Cardiac Surgery

NCT06974071 | Active Not Recruiting

• 1 other identifier: DIM24-0009
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain Management

Keywords

cardiac surgery; pain management; chest drain; non-pharmacological therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Pain measurement at 5, 10 and 20 minutes after drain removal.

Study Arms (3)

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.

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.

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.

Interventions

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.

Local cold application group

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.

Aromatherapy group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de La Frontera: lead

Study Sites (1)

Claro Solar 115, Temuco

Temuco, Araucanía (IX), 4780000, Chile

Location

MeSH Terms

Conditions

Agnosia

Interventions

lavender oil

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc.

Model Details: * 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

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 15, 2025
• Study Start: April 20, 2025
• Primary Completion: September 20, 2025
• Study Completion: December 20, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 3 years after the publication of results

Locations

CL (1)