Aromatherapy Effect on Pain and Anxiety After C-section

Effect of Aromatherapy Using Lavender Essential Oil on Pain and Anxiety After C-section: a Randomized Controlled Trial

A prospective randomized triple blinded study conducted in the obstetrics gynecology department of Ben Arous hospital over a period of four months and 10 days between April 2023 and August 2023.

The aim of this study was to evaluate the effectiveness of lavender aromatherapy on postoperative pain and anxiety after cesarean section under spinal anesthesia in Tunisian women.

Study Overview

• Status: Completed
• Conditions: Post-operative Pain; Post-operative Anxiety
• Intervention / Treatment: Other: Aromatherapy; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tunisia
  • Ben Arous, Tunisia
    • Ben Arous Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• All women who gave birth by cesarean section under spinal anesthesia in the obstetrics and gynecology department at the Ben Arous regional hospital who met the following criteria were included in this study:

  • Age between 18 and 45 years old
  • Term of pregnancy at the time of delivery ≥ 37 weeks of Gestation.
  • A minimum level of primary education as a prerequisite to answer the questions (in particular the STAI items).
  • Classified ASA 1 or 2 of the American Society of Anesthesiology (ASA) classification.
  • Having no history of cancer or chronic pain.
  • Free from any psychiatric pathology.
  • And having not presented any intra- or post-operative complications.

Exclusion Criteria:

The investigators excluded patients in our study:

• Having given birth to a stillborn or a suffering newborn requiring transfer to neonatal intensive care.
• Having received painkillers in the post-operative period.
• Having olfactory disorders.
• Having a substance abuse problem.
• Having a known allergy to lavender or other aromatic plants.
• who did not agree to participate in the study or who did not continue all stages of the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aromatherapy group; Two to twelve hours after undergoing C-section, the women enrolled in the experimental arm benefited from aromatherapy with lavender essential oil (EO): The patients were invited to inhale cotton balls, soaked separately with three drops of the EO at a distance of 10 centimeters for 30 minutes.	Other: Aromatherapy; women enrolled in the experimental group received aromatherapy with lavender essential oil (EO) through dry inhalation (inhalation via a cotton support soaked in a few drops of EO)
Placebo Comparator: Placebo; Two to twelve hours after undergoing C-section, the women enrolled in the placebo arm were invited to inhale cotton balls, soaked separately with three drops of the distilled water at a distance of 10 centimeters for 30 minutes.	Other: Placebo; women enrolled in the placebo group received ihaled a cotton support soaked in a few drops of distilled water

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative pain level	the investigator evaluated the Post-operative pain level using Visual analogue scale( patient at rest and after ambulation). The score ranges from 0 (no pain at all) to 10 (the worst imaginable pain). the higher the score is, the worst the outcome is.	two to twelve hours after surgery
Post-operative anxiety level	the investigator evaluated the Post-operative anxiety level using the " State Trait Anxiety Inventory (STAI)forme Y ". The score ranges from 20 to 80. Higher scores are associated with higher levels of anxiety (worse outcome)	two to twelve hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate (HR)	Heart Rate in beat per minute (bpm),	two to twelve hours after surgery
Systolic Blood Pressure (SBP)	Systolic Blood Pressure (SBP) in millimetres of mercury (mmHg)	two to twelve hours after surgery
Diastolic Blood Pressure (DBP)	Diastolic Blood Pressure (DBP) in millimetres of mercury (mmHg)	two to twelve hours after surgery
Respiratory Rate (RR)	Respiratory Rate (RR) in cycle per minute (cpm)	two to twelve hours after surgery
Pulsatile Oxygen Saturation	Pulsatile Oxygen Saturation (SPO2) in percentage (%).	two to twelve hours after surgery

Collaborators and Investigators

• Sponsor: University Tunis El Manar
• Investigators: Study Director: Hajer Bettaieb, Professor, University of Tunis el Manar, Faculty of medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2023
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: April 20, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Cesarean; Aromatherapy; Lavender
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Anxiety Disorders
• Other Study ID Numbers: 03/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No