Post-operative Anxiety, Post-operative Pain
Conditions
Keywords
Cesarean, Pain, Anxiety, Aromatherapy, Lavender
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.
Interventions
OTHERAromatherapy
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)
OTHERPlacebo
women enrolled in the placebo group received ihaled a cotton support soaked in a few drops of distilled water
Sponsors
University Tunis El Manar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Diastolic Blood Pressure (DBP) | two to twelve hours after surgery | Diastolic Blood Pressure (DBP) in millimetres of mercury (mmHg) |
| Heart Rate (HR) | two to twelve hours after surgery | Heart Rate in beat per minute (bpm), |
| Pulsatile Oxygen Saturation | two to twelve hours after surgery | Pulsatile Oxygen Saturation (SPO2) in percentage (%). |
| 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) |
Countries
Tunisia
Outcome results
None listed