Effect of Aromatherapy on Postoperative Pain: Randomized Clinical Trial

NCT06294769 | Completed

• 1 other identifier: 022024 Maria Fernanda
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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%.

Conditions

Acute Pain; Perioperative/Postoperative Complications; CAM; Nurse's Role

Keywords

Acute Pain; Perioperative Nursing; Aromatherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Blood pressure (both systolic and diastolic)

  2 hours

• Heart rate

  2 hours

• Respiratory frequency

  2 hours

• Oxygen saturation

  2 hours

• Temperature

  2 hours

Study Arms (2)

Group 1: 2% lavender essential oil.

EXPERIMENTAL

Group will receive application of aromatherapy with 2% lavender essential oil dermal and inhalation via by a nurse, associated with usual care, in the immediate postoperative period.

Other: essencial oil of lavandula angustifolia

Group 2: grape seed vegetable oil.

PLACEBO COMPARATOR

Placebo group will only receive the application of grape seed vegetable oil associated with usual care in the post anesthetic recovery room.

Other: grape seed vegetable oil

Interventions

essencial oil of lavandula angustifolia OTHER

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

Group 1: 2% lavender essential oil.

grape seed vegetable oil OTHER

The placebo group will only receive the application of grape seed vegetable oil associated with usual care in the immediate postoperative period.

Group 2: grape seed vegetable oil.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Universidade de São Paulo

São Paulo, São Paulo, 05508-000, Brazil

Location

MeSH Terms

Conditions

Acute Pain; Postoperative Complications

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigador Maria Fernanda

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: March 6, 2024
• Study Start: March 18, 2024
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)