The Effect of Aromatherapy in Laparoscopic Cholecystectomy Patients

September 6, 2023 updated by: Seda Akutay, TC Erciyes University

The Effect of Aromatherapy on Postoperative Pain, Sleep Quality and Physiological Parameters in Laparoscopic Cholecystectomy Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Kayseri, Turkey
        • Erciyes University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group Lavender
Each patient in this group received inhalation aromatherapy of lavender oil.
Other: Intervention group Lavender
This group received inhalation aromatherapy 2 drops of lavender oil from aromastone for a total of 3 days, one day before the operation, the day of the operation and the first day after the operation.
Other Names:
  • Lavender oil
Experimental: Intervention group Geranium
Each patient in this group received inhalation aromatherapy of geranium oil.
Other: Intervention group Geranium
This group received inhalation aromatherapy 2 drops of geranium oil from aromastone for a total of 3 days, one day before the operation, the day of the operation and the first day after the operation.
Other Names:
  • Geranium oil
No Intervention: Control group
Each patient in this group did not receive any additional treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: 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.
change from baseline score at the end of three day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Richards-Campbell Sleep Questionnaire
Time Frame: 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.
change from baseline score at the end of three day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physiological parameter (Blood Pressure)
Time Frame: change from baseline score at the end of three day
The systolic and diastolic blood pressures of the patients were recorded by the researchers the day before, the day of surgery, and the day after surgery.
change from baseline score at the end of three day
Physiological parameter(Heart rate)
Time Frame: change from baseline score at the end of three day
The heart rate of the patients was recorded by the researchers the day before the surgery, the day of the surgery, and the day after the surgery.
change from baseline score at the end of three day
Physiological parameter(Respiratory rate)
Time Frame: change from baseline score at the end of three day
The respiratory rate of the patients was recorded by the researchers the day before the surgery, the day of the surgery, and the day after the surgery.
change from baseline score at the end of three day
Physiological parameter(SPO2)
Time Frame: change from baseline score at the end of three day
The SPO2 of the patients was recorded by the researchers the day before the surgery, the day of the surgery, and the day after the surgery.
change from baseline score at the end of three day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TC Erciyes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2022

Primary Completion (Actual)

May 12, 2022

Study Completion (Actual)

May 12, 2022

Study Registration Dates

First Submitted

June 14, 2022

First Submitted That Met QC Criteria

July 18, 2022

First Posted (Actual)

July 19, 2022

Study Record Updates

Last Update Posted (Actual)

September 7, 2023

Last Update Submitted That Met QC Criteria

September 6, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Erciyessbf

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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