The Impact of Preoperative Aromatherapy Upon Time to First Analgesia Request After Cesarean Section

The Impact of Preoperative Aromatherapy Upon Time to First Analgesia Request and Consumption After Cesarean Section; Randomized Clinical Trial

one of the main aims of anesthesia is to reduce postoperative pain. However, many drugs that are used for this purpose, especially opioids, have side effects such as respiratory distress, nausea, itching, and gastrointestinal bleeding

. Recent studies have indicated interest in using complementary therapies such as heat and cold therapy, hypnotism.

Study Overview

• Status: Recruiting
• Conditions: Pain
• Intervention / Treatment: Drug: aromatherapy blend containing Lavender

Detailed Description

Pain is amongst the most common problems after surgery

(1). Pain is an unpleasant sensory and emotional experience, which is associated with the real or probably damage of tissue. Unrelieved postoperative pain in addition to creating fears in the surgical patients, it makes adverse psychological impact on them

• The uncontrolled postoperative pain will make a lot of acute and chronic effects, including systemic mediators, hypercoagulability, postoperative immunosuppression, and delayed wound healing
• So, one of the main aims of anesthesia is to reduce postoperative pain. However, many drugs that are used for this purpose, especially opioids, have side effects such as respiratory distress, nausea, itching, and gastrointestinal bleeding. Recent studies have indicated interest in using complementary therapies such as heat and cold therapy, hypnotism.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Recruiting
    • Emad Zarief Kamel Said
    • Contact: Emad Z Kamel, M.D.; Phone Number: +201007046058; Email: emadzarief@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 20 and 40 years
• Body mass index (BMI) of 18-35 kg/m2
• Patients with the American Society of Anesthesiologists (ASA) physical status I/II,
• Patients scheduled for elective cesarean section.

Exclusion Criteria:

• Patient refusal

  • Allergy to local anaesthetics
  • Anosmia
  • Coagulopathy,
  • Chronic pain syndromes
  • Prolonged opioid medication
  • Patients who received any analgesic 24 h before surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A aromatherapy; three drops of aromatherapy blend containing Lavender essence 10% were poured on cotton in cast containers, and the patient was asked to inhale it for 5 minutes from a distance of 10 cm	Drug: aromatherapy blend containing Lavender; hree drops of aromatherapy blend containing Lavender essence 10% were poured on cotton in cast containers, and the patient was asked to inhale it for 5 minutes from a distance of 10 cm
No Intervention: Group B Control; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to first analgesia request	time to first analgesia request in minutes	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total daily consumption of analgesia	intravenous keteloac total consumption in the 1st 24 hours	24 hours

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Gupta A, Kaur K, Sharma S, Goyal S, Arora S, Murthy RS. Clinical aspects of acute post-operative pain management & its assessment. J Adv Pharm Technol Res. 2010 Apr;1(2):97-108.
• McQuay H, Derry S, Wiffen P, Moore A, Eccleston C. Postoperative pain management: number-needed-to-treat approach versus procedure-specific pain management approach. Pain. 2013 Jan;154(1):180. doi: 10.1016/j.pain.2012.10.007. Epub 2012 Oct 22. No abstract available.
• Sheikhan F, Jahdi F, Khoei EM, Shamsalizadeh N, Sheikhan M, Haghani H. Episiotomy pain relief: Use of Lavender oil essence in primiparous Iranian women. Complement Ther Clin Pract. 2012 Feb;18(1):66-70. doi: 10.1016/j.ctcp.2011.02.003. Epub 2011 Mar 16. Erratum In: Complement Ther Clin Pract. 2012 Aug;18(3):195.

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: October 29, 2023
• First Submitted That Met QC Criteria: October 29, 2023
• First Posted (Actual): November 2, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB8888888888

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No