The Effect of Aromatherapy in Laparoscopic Cholecystectomy Patients

Not Applicable

Completed

• Conditions: Aromatherapy; Cholecystectomy
• Interventions: Other: Intervention group Lavender; Other: Intervention group Geranium

• Registration Number: NCT05464602
• Lead Sponsor: TC Erciyes University

Brief Summary

Pain experienced before and after surgery in patients undergoing laparoscopic cholecystectomy adversely affects physiological parameters and sleep quality. This randomized controlled study was conducted to examine the effects of preoperative and postoperative inhalation lavender and geranium essential oil on patients undergoing laparoscopic cholecystectomy on pain, sleep, and physiological parameters. The study was completed with 3 groups and 150 people, namely the geranium oil group (n=50), lavender oil group (n=50) and control group (n=50). The ethics committee approval, informed consent of the individuals and the institutional permission were obtained. In the study, data were collected using the patient identification form, Richard-Campbell Sleep Scale and visual analog scale. Chi-square test,repeated measures one-way analysis of variance, and Spearman correlation analysis tests were used to assess the data. In the comparisons, the value of p\<0.05 was accepted as significant.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-27
• Primary Completion: 2022-05-12
• Study Completion: 2022-05-12
• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-07-18
• Study First Posted: 2022-07-19
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients aged ≥18 years
• Hospitalized for laparoscopic cholecystectomy surgery,
• Alzheimer's, dementia etc. no disease,
• Having no perception problems (sense of smell, vision, hearing loss),
• Hospitalized the day before the operation,
• Patients who continue to stay in the hospital for at least one night after the operation will be included in the study.

Exclusion Criteria

• Having any respiratory system disease (COPD, Asthma, etc.),
• Disturbed by the smell of essential oils,
• Any allergic diagnosis and history,
• Using anxiolytic, antidepressant,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group Lavender	Intervention group Lavender	Each patient in this group received inhalation aromatherapy of lavender oil.
Intervention group Geranium	Intervention group Geranium	Each patient in this group received inhalation aromatherapy of geranium oil.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale	change from baseline score at the end of three day	The range of 0 (zero) and 10cm is determined on a ruler. 0 (zero) means "no pain" and 10 means "worst possible pain". The patient is asked to mark the place that expresses the pain on the line. The distance marked by the patient is measured by taking the initial distance of zero.

Secondary Outcome Measures

Name	Time	Method
The Richards-Campbell Sleep Questionnaire	change from baseline score at the end of three day	The Richard Campbell Sleep Questionnaire is a 6-item scale that evaluates the depth of sleep, the time to fall asleep, the frequency of awakening, the time to stay awake, the quality of sleep, and the noise level in the environment. Each item is evaluated on a chart with scores between 0 and 100. If the total mean score obtained from the scale is between "0-25", it indicates very bad sleep, between "26-75" indicates moderate sleep, and between "76-100" indicates very good sleep. The higher the score obtained from the scale, the higher the sleep quality of the patient is considered.

Trial Locations

Locations (1)

Erciyes University; 🇹🇷 Kayseri, Turkey