Post-operative Pain Clinical Trial
Official title:
Effect of Aromatherapy Using Lavender Essential Oil on Pain and Anxiety After C-section: a Randomized Controlled Trial
NCT number | NCT06387849 |
Other study ID # | 03/2023 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 21, 2023 |
Est. completion date | August 31, 2023 |
Verified date | April 2024 |
Source | University Tunis El Manar |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | August 31, 2023 |
Est. primary completion date | August 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Tunisia | Ben Arous Regional Hospital | Ben Arous |
Lead Sponsor | Collaborator |
---|---|
University Tunis El Manar |
Tunisia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Secondary | Heart Rate (HR) | Heart Rate in beat per minute (bpm), | two to twelve hours after surgery | |
Secondary | Systolic Blood Pressure (SBP) | Systolic Blood Pressure (SBP) in millimetres of mercury (mmHg) | two to twelve hours after surgery | |
Secondary | Diastolic Blood Pressure (DBP) | Diastolic Blood Pressure (DBP) in millimetres of mercury (mmHg) | two to twelve hours after surgery | |
Secondary | Respiratory Rate (RR) | Respiratory Rate (RR) in cycle per minute (cpm) | two to twelve hours after surgery | |
Secondary | Pulsatile Oxygen Saturation | Pulsatile Oxygen Saturation (SPO2) in percentage (%). | two to twelve hours after surgery |
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