Aromatherapy Effect on Pain and Anxiety After C-section

Post-operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06387849
• Other study ID #: 03/2023
• Status: Completed
• Phase: N/A
• Start date: April 21, 2023
• Est. completion date: August 31, 2023

Study information

• Verified date: April 2024
• Source: University Tunis El Manar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Pain, Postoperative
• Post-operative Pain

Intervention

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
women enrolled in the placebo group received ihaled a cotton support soaked in a few drops of distilled water

Locations

Country	Name	City	State
Tunisia	Ben Arous Regional Hospital	Ben Arous

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

Outcome

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