- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06060418
Effect of Lavender Aromatherapy on Post-Operative Nausea and Vomiting Among Laparotomy Patients
Effect of Lavender Aromatherapy on Post-Operative Nausea and Vomiting Among Laparotomy Patients at DHQ Sheikhupura Punjab, Pakistan
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Design:
Randomized Control trial( RCT)
Study population:
Patients undergoing laparotomy under general anesthesia
Setting:
This study will be carried out at the Institute of Nursing, University of Health Sciences Lahore in collaboration with DHQ Sheikhupura Punjab, Pakistan. This hospital offers 24/7 services in emergency, medicine, surgery, gynecology and pediatrics etc.
Sample Size:
The sample size for each group is 35 and total is 70.
Sampling Technique and Randomization:
A non-probability convenience sampling approach will be utilized for patient enrollment. patients will be randomly assigned to either the intervention or control group through computer-generated table numbers.
Data Collection Procedure and Method of Intervention; Upon receiving approval from the Institutional Review Board of the University of Health Sciences Lahore, formal authorization will be sought from DHQ. Eligible participants will be identified and selected in accordance with predetermined inclusion and exclusion criteria. After explaining the study purpose, the researcher will obtain informed written consent before their surgical procedure. Upon patients' arrival to the HDU following their laparotomy, those who present complaints of postoperative nausea and vomiting will be subject to randomization into either the intervention or control group. This randomization will be executed using computer-generated table numbers. First, the researcher will gather pertinent demographic information from the enrolled participants.
Adequate guarantees of confidentiality shall be extended to all participants.
Method of Intervention:
After deciding the participant of intervention group the intervention will be started if NRS score is > 1 for nausea and with the 1st episode of vomiting.
The researcher will soak a 4×4 cm sterile gauze pad with 0.2 ml equivalent to 2 drops of 10% Lavender essential oil and will suspended the soaked gauze at a distance of 10cm from the patient's nose with the help of forcep, and he or she will have asked to inhale its scent for 5 min. 15 and 40 minutes after the beginning of the aromatherapy treatment, the researcher will measure the nausea and vomiting scores by using the standardized tool. During this entire 40 minutes the researcher will strictly monitor the participant's condition. If the nausea score will be still higher than 1 or vomiting persists the participants will be noted as failure of treatment and move to standard care and the control group received standard care against the complaint of nausea and vomiting.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nosheen Siddique, MSN
- Phone Number: 03323028885
- Email: nosheensiddique244@gmail.com
Study Contact Backup
- Name: Sidra Muattar, MSN
- Phone Number: 03364014042
- Email: sidrasaeed2112@gmail.com
Study Locations
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Punjab
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Sheikhupura, Punjab, Pakistan, 39350
- Nosheen Siddique
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Those patients: -
- with 18 -65 years
- both Male and Female
- who received general anesthesia for surgery
- who experience nausea and vomiting within 24hr after surgery
- who hemodynamically stable
Exclusion Criteria:
Those patients
• who move to ICU after the Procedure
- with history of substance addiction
- having history of pre-op nausea and vomiting
- with history of motion sickness
- who start Oral or Naso Gastric Feed after surgery
- having history of Lung disease, ant type of allergy or infection
- who need laparotomy reversal short after the procedure
- Who received antiemetic before surgery
- who went to any type of complication during the procedure not included in this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
After deciding on the participant of the intervention group the researcher will start the protocol of intervention The researcher will soak a 4×4 cm sterile gauze pad with 0.2 ml equivalent to 2 drops of 10% Lavender essential oil and will suspend the soaked gauze at a distance of 10cm from the patient's nose with the help of forceps, and he or she will have asked to inhale its scent for 5 min.
15 and 40 minutes after the beginning of the aromatherapy treatment, the researcher will measure the nausea and vomiting scores by using the standardized tool.
During this entire 40 minutes, the researcher will strictly monitor the participant's condition.
If the nausea score is still higher than 1 or the vomiting persists the participants will be noted as failure of treatment and move to standard care.
|
aromatherapy with essential oil is being used as a non-pharmacological nursing intervention within the health care setting.
This approach aims to manage the patient's discomfort and alleviate the symptoms of postoperative nausea and vomiting.
One of the most beneficial oils is Lavender Essential Oil (LEO), which is used to treat a variety of digestive issues.
|
No Intervention: Control group
The control group received standard care against the complain of nausea and vomiting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of postoperative nausea Intensity
Time Frame: with in 24 hour after the surgery
|
When a patient encounters nausea within the initial 24 hours subsequent to the laparotomy, the researcher will adopt the Numeric Rating Scale (NRS) to quantify the intensity of the experienced nausea. The NRS is a one-dimensional quantitative 11-point pain rating scale that has also been validated to detect nausea by using the content validity method, and its score is 1 which is appropriate to measure the nausea intensity. The researcher will operate this scale by using the verbal scale because self-assessed nausea scores from the NRS and the verbal scale correlated well as rSpearman = 0.79. The researcher will ask the patient to select a number from 0 to 10 that best describes the intensity of their nausea at that precise moment. |
with in 24 hour after the surgery
|
Measurement of postoperative Vomiting frequency and severity
Time Frame: with in 24 hour after the surgery
|
in scenarios where a patient reports episodes of vomiting during the initial 24-hour postoperative period, the researcher will utilize the Likert scale to assess both the frequency and severity of these vomiting incidents. Vomiting will be assessed by using a Likert Scale that was also validated on 10% of the sample size. The CVI was 1 and Cronbach alpha was 0.79 which is appropriate to measure the severity of vomiting. The researcher will rate the severity of vomiting as 0 to 4, with 0 representing no vomiting and 4 representing severe vomiting. The number of occurrences indicates the severity (0 = no episode, 1 = 1-2 episodes, 2 = 3-4 episodes, 3 = 5 or more episodes) |
with in 24 hour after the surgery
|
Collaborators and Investigators
Investigators
- Principal Investigator: Nosheen Siddique, MSN, University of Health Sciences Lahore
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Aroma RCT 2023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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