Aromatherapy Effect on Pain and Anxiety After C-section

NCT ID: NCT06387849

Last Updated: 2024-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-21

Study Completion Date

2023-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Post-operative Pain Post-operative Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Aromatherapy group

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.

Group Type EXPERIMENTAL

Aromatherapy

Intervention Type 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)

Placebo

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

women enrolled in the placebo group received ihaled a cotton support soaked in a few drops of distilled water

Interventions

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Aromatherapy

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)

Intervention Type OTHER

Placebo

women enrolled in the placebo group received ihaled a cotton support soaked in a few drops of distilled water

Intervention Type OTHER

Eligibility Criteria

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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:

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Tunis El Manar

OTHER

Sponsor Role lead

Responsible Party

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Nesrine Souayeh

Associated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hajer Bettaieb, Professor

Role: STUDY_DIRECTOR

University of Tunis el Manar, Faculty of medicine

Locations

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Ben Arous Regional Hospital

Ben Arous, , Tunisia

Site Status

Countries

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Tunisia

References

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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.

Reference Type DERIVED
PMID: 39400653 (View on PubMed)

Other Identifiers

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03/2023

Identifier Type: -

Identifier Source: org_study_id

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