Clinical trial NCT06060418: Effect of Lavender Aromatherapy on Post-Operative Nausea and Vomiting Among Laparotomy Patients
Official title: Effect of Lavender Aromatherapy on Post-Operative Nausea and Vomiting Among Laparotomy Patients At DHQ Sheikhupura Punjab, Pakistan
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: University of Health Sciences Lahore
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measurement of postoperative nausea Intensity
timeFrame: with in 24 hour after the surgery
measure: Measurement of postoperative Vomiting frequency and severity
timeFrame: with in 24 hour after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Sheikhupura
country: Pakistan
facility: Nosheen Siddique
state: Punjab
Study officials:
affiliation: University of Health Sciences Lahore
name: Nosheen Siddique, MSN
role: PRINCIPAL_INVESTIGATOR
References: