The Effect of Aromatherapy in Laparoscopic Cholecystectomy Patients

Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05464602
• Other study ID #: Erciyessbf
• Status: Completed
• Phase: N/A
• Start date: January 27, 2022
• Est. completion date: May 12, 2022

Study information

• Verified date: September 2023
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 12, 2022
• Est. primary completion date: May 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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,

Related Conditions & MeSH terms

• Aromatherapy
• Cholecystectomy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Erciyes University	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Abdelhakim AM, Hussein AS, Doheim MF, Sayed AK. The effect of inhalation aromatherapy in patients undergoing cardiac surgery: A systematic review and meta-analysis of randomized controlled trials. Complement Ther Med. 2020 Jan;48:102256. doi: 10.1016/j.ctim.2019.102256. Epub 2019 Nov 23. — View Citation

Bikmoradi A, Seifi Z, Poorolajal J, Araghchian M, Safiaryan R, Oshvandi K. Effect of inhalation aromatherapy with lavender essential oil on stress and vital signs in patients undergoing coronary artery bypass surgery: A single-blinded randomized clinical trial. Complement Ther Med. 2015 Jun;23(3):331-8. doi: 10.1016/j.ctim.2014.12.001. Epub 2014 Dec 11. — View Citation

Hwang E, Shin S. The effects of aromatherapy on sleep improvement: a systematic literature review and meta-analysis. J Altern Complement Med. 2015 Feb;21(2):61-8. doi: 10.1089/acm.2014.0113. Epub 2015 Jan 13. — View Citation

Lillehei AS, Halcon LL, Savik K, Reis R. Effect of Inhaled Lavender and Sleep Hygiene on Self-Reported Sleep Issues: A Randomized Controlled Trial. J Altern Complement Med. 2015 Jul;21(7):430-8. doi: 10.1089/acm.2014.0327. Epub 2015 Jun 2. — View Citation

Saritas S, Kavak F, Savas B. The effect of lavender oil on anxiety levels of patients before laparoscopic cholecystectomy. Complement Ther Clin Pract. 2018 Aug;32:51-54. doi: 10.1016/j.ctcp.2018.05.003. Epub 2018 May 5. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Physiological parameter (Blood Pressure)	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
Other	Physiological parameter(Heart rate)	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
Other	Physiological parameter(Respiratory rate)	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
Other	Physiological parameter(SPO2)	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
Primary	Visual Analog Scale	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	The Richards-Campbell Sleep Questionnaire	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