Clinical trial NCT05464602: The Effect of Aromatherapy in Laparoscopic Cholecystectomy Patients
Official title: The Effect of Aromatherapy on Postoperative Pain, Sleep Quality and Physiological Parameters in Laparoscopic Cholecystectomy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystectomy
Aromatherapy
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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,

Primary outcomes:
measure: Visual Analog Scale
timeFrame: change from baseline score at the end of three day
Secondary outcomes:
measure: The Richards-Campbell Sleep Questionnaire
timeFrame: change from baseline score at the end of three day
Other outcomes:
measure: Physiological parameter (Blood Pressure)
timeFrame: change from baseline score at the end of three day
measure: Physiological parameter(Heart rate)
timeFrame: change from baseline score at the end of three day
measure: Physiological parameter(Respiratory rate)
timeFrame: change from baseline score at the end of three day
measure: Physiological parameter(SPO2)
timeFrame: change from baseline score at the end of three day
Locations:
city: Kayseri
country: Turkey
facility: Erciyes University
Study officials:
References:
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.
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.
citation: 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.
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.
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.