Claro Solar 115, Temuco
Temuco, Araucanía (IX), 4780000, Chile
NCT Number: NCT06974071
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.
This study is active but is not currently recruiting participants.
Notify Me20 year–80 year
All sexes
Interventional
Not applicable
Temuco, Araucanía (IX), 4780000, Chile
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)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
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.
Universidad de La Frontera
Other
Effectiveness of Nonpharmacologic Therapies on Pain After Removal of Chest Drains in Postoperative Cardiac Surgery, Study Protocol
Acronym: NPT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02523443
Agnosia, Digestive System Diseases
Basking Ridge, New Jersey, United States
View Trial DetailsNCT07692516
Agnosia, Carpal Tunnel Syndrome
Lleida, Spain
View Trial DetailsNCT07629661
Agnosia, Decision Support Systems, Clinical
Rotterdam, Netherlands
View Trial DetailsNCT07489872
Agnosia, Nervous System Diseases
Istanbul, Turkey (Türkiye)
View Trial Details