Effect of Aromatherapy on Postoperative Pain: Randomized Clinical Trial

Acute Pain Clinical Trial

Official title:

Effect of Aromatherapy on Postoperative Pain in Adult Patients in Post-anesthesics Recovering Room: Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06294769
• Other study ID #: 022024 Maria Fernanda
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2024
• Est. completion date: July 19, 2024

Study information

• Verified date: May 2024
• Source: University of Sao Paulo
• Contact: Maria Faria, Ms
• Phone: 55-11-997575050
• Email: maria.fernanda.faria[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Introduction: Pain is one of the main complications in the immediate postoperative period that can harm the patient and can be managed through pharmacological and non-pharmacological methods. Complementary Integrative Health Practices are non-pharmacological methods that use therapeutic resources based on traditional knowledge to treat symptoms. Among them, aromatherapy stands out, which consists of the use of essential oils through inhalation or topical application for therapeutic purposes and which can be used as a nursing intervention, especially in the context of perioperative care. Objective: To evaluate the effect of aromatherapy on postoperative pain in adult patients in the immediate postoperative period. Method: This is a randomized controlled clinical trial that will be carried out in a teaching hospital. The project was submitted to the Research Ethics Committees of the School of Nursing of the University of Sao Paulo and the University of Sao Paulo Hospital. Adult patients undergoing elective surgical procedures of any surgical specialty under anesthesia of any type will be included. Individuals diagnosed with dementia, cognitive impairment or chronic pain will be excluded; individuals with a history of asthma, allergic bronchitis, chronic obstructive pulmonary disease, contact dermatitis or allergy to cosmetics with lavender fragrance, or hypersensitivity to the compounds used in the intervention; procedure for reoperation for any reason. The intervention will consist of the application of aromatherapy with 2% lavender essential oil through the skin and inhalation by a nurse, associated with usual care, in the immediate postoperative period; the placebo group will only receive the application of grape seed vegetable oil associated with usual care. A numerical verbal scale will be applied to assess pain and vital parameters will be measured upon patient admission, every fifteen minutes in the first hour and every thirty minutes in the second hour or after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after applying the intervention, in the post-anesthesia recovery room. Possible associations between variables will be verified using Pearson's Chi-square or Fisher's exact tests. Comparison between means or medians will be made using the Student's t or Mann-Whitney tests, depending on the normality determined according to the Kolmogorov-Smirnov test. The significance level adopted will be 5%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: July 19, 2024
• Est. primary completion date: June 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• adult patients undergoing elective surgical procedures of any surgical specialty under anesthesia of any type

Exclusion Criteria:

• individuals diagnosed with dementia, cognitive impairment or chronic pain;

• individuals with a history of asthma, allergic bronchitis, chronic obstructive pulmonary disease, contact dermatitis or allergy to cosmetics with lavender fragrance, or hypersensitivity to the compounds used in the intervention;

• procedure for reoperation for any reason

Related Conditions & MeSH terms

• Acute Pain
• CAM
• Nurse's Role
• Pain, Postoperative
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Other:
• essencial oil of lavandula angustifolia
The intervention will consist of the application of aromatherapy with 2% lavender essential oil cutaneously and inhalation via by a nurse, associated with usual care, in the immediate postoperative period
• grape seed vegetable oil
The placebo group will only receive the application of grape seed vegetable oil associated with usual care in the immediate postoperative period.

Locations

Country	Name	City	State
Brazil	Universidade de São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute pain	A numerical verbal scale (1 to 10) for assessing pain upon patient admission, after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after application intervention, in the post-anesthesia recovery room.	2 hours
Secondary	Blood pressure (both systolic and diastolic)	Non-invasive blood pressure measurement (in mmHg) upon patient admission, after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after application intervention, in the post-anesthesia recovery room	2 hours
Secondary	Heart rate	Heart rate measurement with multi parameter monitor(in bpm) upon patient admission, after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after application intervention, in the post-anesthesia recovery room	2 hours
Secondary	Respiratory frequency	Respiratory frequency assessment (breathing rate by counting the number of breaths per minute) upon patient admission, after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after application intervention, in the post-anesthesia recovery room	2 hours
Secondary	Oxygen saturation	Oxygen saturation (SpO2) measurement (in percent (%), with a pulse oximeter non-invasive device) upon patient admission, after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after application intervention, in the post-anesthesia recovery room	2 hours
Secondary	Temperature	Temperature assessment (in Celsius scale ) upon patient admission, after 15, 30, 45, 60 minutes, 1h30 minutes and 2 hours after application intervention, in the post-anesthesia recovery room	2 hours