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Aromatherapy Effect on Pain and Anxiety After C-section

U

University Tunis El Manar

Status

Completed

Conditions

Post-operative Pain
Post-operative Anxiety

Treatments

Other: Placebo
Other: Aromatherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT06387849
03/2023

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 2 patient groups, including a placebo group

Aromatherapy group
Experimental group
Description:
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.
Treatment:
Other: Aromatherapy
Placebo
Placebo Comparator group
Description:
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.
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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