Effect of Lavender Aromatherapy on Post-Operative Nausea and Vomiting Among Laparotomy Patients

Study Overview
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Brief Summary
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Post-operative nausea and vomiting are critical problems that occur commonly after the administration of general anesthesia, which can lead to serious health complications such as hemorrhage, electrolyte imbalance and ultimate shock. To prevent these complications, antiemetic drugs are often administered, but they can cause side effects as well as increased healthcare costs. As concerns regarding the side effects of antiemetic drugs have grown, there has been an increased interest in using non-pharmacologic interventions, such as aromatherapy, as an alternative approach to preventing post-operative nausea and vomiting. It involves the therapeutic use of essential oils, and lavender essential oil, in particular, is commonly used for various digestive problems including nausea, and vomiting. Therefore, a key question for a health care professional is how to prevent post-operative nausea and vomiting in best possible manner? To address this question, a study will be conducted in District Head Quarter Sheikhupura, aiming to evaluate the effectiveness of lavender essential oil aromatherapy in reducing post-operative nausea and vomiting among patients admitted for laparotomy under general anesthesia. This study will be a Randomized control trial with the study population consisting of admitted patients after laparotomy under general anesthesia. The sample size will be 70, who will be divided into two groups, each consisting of 35 participants. A convenience sampling technique will be employed for the recruitment of participants. After that, the participants will be randomized into control and intervention groups by computer-generated table numbers in accordance with the inclusion criteria that is, 18-65 age, both genders, laparotomy under general anesthesia, clinically stable, and susceptive to post-op nausea and vomiting within 24hrs following the surgery. whereas, the patients with respiratory diseases, allergies, infections, reversal laparotomy within short duration, having any kind of addiction, those who move to the intensive care unit, those with a history of motion sickness, history of pre-op nausea and vomiting and those who start oral or NG feed before 24hrs will not be part of this study. The data will be analyzed by using Statistical Package for Social Sciences version 22.

Detailed Description
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Study Design: This will be a Randomized Control trial. Study population: The population of this study will be the admitted patients undergoing laparotomy under general anesthesia and meeting the specified inclusion criteria. Setting: This study will be carried out at the Institute of Nursing, University of Health Sciences Lahore in collaboration with District Head Quarter 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 calculated by WHO calculator 2.0 by using two proportion formula with 80% power of study,95% confidence level. Sampling Technique and Randomization: A non-probability convenience sampling approach will be utilized for patient enrollment. Subsequently, patients will be randomly assigned to either the intervention or control group through the utilization of computer-generated table numbers, facilitated by Random Allocation Software. Data Collection Procedure and Method of Intervention; Ethical Protocol and Participant Recruitment Strategy: Upon receiving approval from the Institutional Review Board of the University of Health Sciences Lahore, formal authorization will be sought from Services Hospital Lahore. Eligible participants will be identified and selected in accordance with predetermined inclusion and exclusion criteria, as well as the established sample size. Employing the convenience sampling technique, the individuals meeting the criteria will be invited to participate. Following an introduction to the study's objectives and methodologies, the researcher will provide a comprehensive outline of the research's aims and procedures. Informed written consent will subsequently be obtained from the patients prior to their surgical procedure, capitalizing on their optimum cognitive state with a Glasgow Coma Scale score of 15/15, thus enabling them to comprehend the impending intervention thoroughly. Participant Randomization and Data Collection Protocol in the High Dependency Unit (HDU): 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. Primarily, the researcher will gather pertinent demographic information from the enrolled participants. This task will be facilitated by employing a demographic questionnaire. The questionnaire, proven in its utility, comprehensively captures various facets of the participants' demographic profiles. Moreover, substantial components of the participants' medical history will be sourced from their respective hospital files, ensuring a comprehensive and accurate compilation of relevant information. Ensuring Participant Privacy and Autonomy; Utilizing established clinical assessment instruments, the investigator endeavors to proficiently measure and record the severity of nausea and vomiting among post-operative patients. Adequate guarantees of confidentiality shall be extended to all participants, emphasizing that data elicited from them will be handled with the utmost discretion. It shall be explicitly communicated that the confidentiality of their identities and individual particulars will be diligently upheld throughout the duration of the study. Moreover, participants shall be firmly assured of their right to discontinue their participation in the study at any stage, exempt from the obligation to provide an explanation. 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.

Official Title
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Effect of Lavender Aromatherapy on Post-Operative Nausea and Vomiting Among Laparotomy Patients at DHQ Sheikhupura Punjab, Pakistan

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Other: aromtherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients from the age of 18 -65 years according to the ethical principles of world medical association (WMA) declaration of Helsinki Patients with both gender Male and Female Patients who will be administered general anesthesia for laparotomy Those who experience nausea and vomiting within 24hr following the laparotomy Patients who will be clinically stable Exclusion Criteria: • Patients who move to intensive care unit after surgery Patients with history of any type of addiction Patients with history of pre-op nausea and vomiting due to hospital environment Patients with history of motion sickness Patients who start Oral /NG Feed after laparotomy Patients with respiratory diseases, allergies, infections Reversal laparotomy within short duration Who received pre or intra-op antiemetic Those who experience any complication during laparotomy will be excluded from this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: After deciding the participant of intervention group the researcher will start the protocol of intervention The intervention will start 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 complain of nausea and vomiting.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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. | Other: aromtherapy<br>* 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.<br>|
| No Intervention: Control group<br>The control group received standard care against the complain of nausea and vomiting. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of postoperative nausea Intensity | 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 | 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 |