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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06114472
• Other study ID #: IRB8888888888
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: November 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

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

Locations

Country	Name	City	State
Egypt	Emad Zarief Kamel Said	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to first analgesia request	time to first analgesia request in minutes	24 hours
Secondary	Total daily consumption of analgesia	intravenous keteloac total consumption in the 1st 24 hours	24 hours