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

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06114472
Collaborator
(none)
60
1
2
7
8.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: aromatherapy blend containing Lavender
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Impact of Preoperative Aromatherapy Upon Time to First Analgesia Request and Consumption After Cesarean Section; Randomized Clinical Trial
Actual Study Start Date :
Oct 31, 2023
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
May 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. time to first analgesia request [24 hours]

    time to first analgesia request in minutes

Secondary Outcome Measures

  1. Total daily consumption of analgesia [24 hours]

    intravenous keteloac total consumption in the 1st 24 hours

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Emad Zarief Kamel Said Assiut Egypt 71111

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Emad Zarief , MD, professor, Assiut University
ClinicalTrials.gov Identifier:
NCT06114472
Other Study ID Numbers:
  • IRB8888888888
First Posted:
Nov 2, 2023
Last Update Posted:
Nov 7, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 7, 2023