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NCT05853744
Effect of Aromatherapy on Preoperative Anxiety Level
Phase 4 trial testing lavender essential oil inhaled using cotton balls in Anxiety in 90 participants. Completed in 30 December 2023.
31 October 2023
Quick facts
| Lead sponsor | Mongi Slim Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 90 |
| Start date | 2 August 2023 |
| Primary completion | 31 October 2023 |
| Estimated completion | 30 December 2023 |
| Sites | 1 location across Tunisia |
Drugs / interventions tested
- lavender essential oil inhaled using cotton balls — full drug profile →
- lavender essential oil inhaled using face mask — full drug profile →
- Distilled water — full drug profile →
Conditions studied
- Anxiety — all drugs for Anxiety →
- Aromatherapy — all drugs for Aromatherapy →
- Anesthesia, Spinal — all drugs for Anesthesia, Spinal →
- Postoperative Period — all drugs for Postoperative Period →
Sponsor
Mongi Slim Hospital
Who can join
18 and older, any sex, with Anxiety or Aromatherapy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of the study was to evaluate the efficacy of lavender aromatherapy in reducing pre-operative anxiety in patients undergoing surgical procedures under spinal anesthesia. This was a prospective double blinded randomized controlled trial. After patient's approval, the anxiety level was assessed preoperativetively with Visual Analogue scale-anxiety and APAIS scale. To rule out any lavender sensitivity, all subjects were given a skin patch test. This was accomplished by applying a drop of lavender oil to the back of the hand and covering it with a Tegaderm dressing to prevent inhalation and spread of the oil. After randomisation and allocation, the investigators prooceeded with the intervention preoperatively. In the operating room, the acte under spinal anethesia was performed. Then we collect data postoperatively.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05853744
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Other Mongi Slim Hospital trials
Trials by the same sponsor.
- NCT06511427 — Difficult Airways Scores Validation Difficult Laryngoscopy and Mask Ventilation: Prospective and Evaluative Study · not yet recruiting
- NCT06676865 — Preoperative Prediction of Difficult Laryngoscopy in Diabetic Patients: Importance of the Palm Print Test · completed
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- NCT06203353 — Evaluation of the Diaphragm Performance During Weaning From Mechanical Ventilation · unknown
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05853744 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mongi Slim Hospital
- Last refreshed: 18 July 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05853744.
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