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

NCT06114472 | Unknown

• 1 other identifier: IRB8888888888
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• time to first analgesia request

  time to first analgesia request in minutes

  24 hours

Secondary Outcomes (1)

• Total daily consumption of analgesia

  24 hours

Study Arms (2)

Group A aromatherapy

ACTIVE COMPARATOR

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

Group B Control

NO INTERVENTION

No intervention

Interventions

aromatherapy blend containing Lavender DRUG

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

Group A aromatherapy

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Emad Zarief Kamel Said

Asyut, 71111, Egypt

RECRUITING

Related Publications (3)

• 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.

  PMID: 23200259 BACKGROUND

• 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.

  PMID: 22247838 BACKGROUND

• 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.

  PMID: 22196577 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 29, 2023
• First Posted: November 2, 2023
• Study Start: October 31, 2023
• Primary Completion: April 30, 2024
• Study Completion: May 30, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)