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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aromatherapy group | Experimental | 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. |
|
| Placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate (HR) | Heart Rate in beat per minute (bpm), | two to twelve hours after surgery |
| Systolic Blood Pressure (SBP) | Systolic Blood Pressure (SBP) in millimetres of mercury (mmHg) |
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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:
Exclusion Criteria:
The investigators excluded patients in our study:
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| Name | Affiliation | Role |
|---|---|---|
| Hajer Bettaieb, Professor | University of Tunis el Manar, Faculty of medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ben Arous Regional Hospital | Ben Arous | Tunisia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39400653 | Derived | Nouira M, Souayeh N, Kanzari SA, Rouis H, Lika A, Mbarki C, Rahali FZ, Bettaieb H. Aromatherapy Using Lavender Oil Effectiveness on Pain and Anxiety After C-Section: A Randomized Controlled Trial. J Epidemiol Glob Health. 2024 Dec;14(4):1536-1544. doi: 10.1007/s44197-024-00305-6. Epub 2024 Oct 14. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D019341 | Aromatherapy |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D008517 | Phytotherapy |
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| Placebo | Other | women enrolled in the placebo group received ihaled a cotton support soaked in a few drops of distilled water |
|
| two to twelve hours after surgery |
| Diastolic Blood Pressure (DBP) | Diastolic Blood Pressure (DBP) in millimetres of mercury (mmHg) | two to twelve hours after surgery |
| Respiratory Rate (RR) | Respiratory Rate (RR) in cycle per minute (cpm) | two to twelve hours after surgery |
| Pulsatile Oxygen Saturation | Pulsatile Oxygen Saturation (SPO2) in percentage (%). | two to twelve hours after surgery |
| D012816 | Signs and Symptoms |
| D001523 | Mental Disorders |
| D026421 |
| Sensory Art Therapies |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |