跳至主要内容
临床试验/NCT06060418
NCT06060418尚未招募不适用

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

University of Health Sciences Lahore2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年8月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
试验地点
2
主要终点
Measurement of postoperative nausea Intensity

研究概览

简要总结

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.

详细描述

Study Design:

Randomized Control trial( RCT)

Study population:

Patients undergoing laparotomy under general anesthesia

Setting:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

The ward Manager/Head Nurse will act as an outcome assessor and blind to the intervention group and control group

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Measurement of postoperative nausea Intensity

时间窗: 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.

Measurement of postoperative Vomiting frequency and severity

时间窗: 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)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nosheen Siddique

MS Nursing Scholar

University of Health Sciences Lahore

研究点 (2)

Loading locations...

相似试验

Effect of Lavender Aromatherapy on Post-Operative... | 临床试验