Aromatherapy Effect on Pain and Anxiety After C-section

Not Applicable

Completed

• Conditions: Post-operative Pain; Post-operative Anxiety

• Registration Number: NCT06387849
• Lead Sponsor: University Tunis El Manar

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-21
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2024-04
• Study First Submitted: 2024-04-20
• Study First Submitted QC: 2024-04-24
• Last Update Submitted: 2024-04-24
• Study First Posted: 2024-04-29
• Last Update Posted: 2024-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Post-operative pain level	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.
Post-operative anxiety level	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 Outcome Measures

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

Trial Locations

Locations (1)

Ben Arous Regional Hospital; 🇹🇳 Ben Arous, Tunisia