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Completed

NCT Number: NCT06387849

Aromatherapy Effect on Pain and Anxiety After C-section

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ben Arous Regional Hospital

Ben Arous, Tunisia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aromatherapy

Other

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

Other

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

Primary outcomes

  1. Post-operative pain level

    Time frame: two to twelve hours after surgery

    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.

  2. Post-operative anxiety level

    Time frame: two to twelve hours after surgery

    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)

Secondary outcomes

  1. Heart Rate (HR)

    Time frame: two to twelve hours after surgery

    Heart Rate in beat per minute (bpm),

  2. Systolic Blood Pressure (SBP)

    Time frame: two to twelve hours after surgery

    Systolic Blood Pressure (SBP) in millimetres of mercury (mmHg)

  3. Diastolic Blood Pressure (DBP)

    Time frame: two to twelve hours after surgery

    Diastolic Blood Pressure (DBP) in millimetres of mercury (mmHg)

  4. Respiratory Rate (RR)

    Time frame: two to twelve hours after surgery

    Respiratory Rate (RR) in cycle per minute (cpm)

  5. Pulsatile Oxygen Saturation

    Time frame: two to twelve hours after surgery

    Pulsatile Oxygen Saturation (SPO2) in percentage (%).

Sponsors and collaborators

Lead sponsor

University Tunis El Manar

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 29, 2024
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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