Aromatherapy Effect on Pain and Anxiety After C-section

NCT06387849 | Completed

• 1 other identifier: 03/2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Pain; Post-operative Anxiety

Keywords

Cesarean; Pain; Anxiety; Aromatherapy; Lavender

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• Heart Rate (HR)

  two to twelve hours after surgery

• Systolic Blood Pressure (SBP)

  two to twelve hours after surgery

• Diastolic Blood Pressure (DBP)

  two to twelve hours after surgery

• Respiratory Rate (RR)

  two to twelve hours after surgery

• Pulsatile Oxygen Saturation

  two to twelve hours after surgery

Study Arms (2)

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.

Other: Aromatherapy

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.

Other: Placebo

Interventions

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)

Aromatherapy group

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Tunis El Manar: lead

Study Sites (1)

Ben Arous Regional Hospital

Ben Arous, Tunisia

Location

Related Publications (1)

• 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.

  PMID: 39400653 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pain; Anxiety Disorders

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Hajer Bettaieb, Professor

  University of Tunis el Manar, Faculty of medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: April 20, 2024
• First Posted: April 29, 2024
• Study Start: April 21, 2023
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)