The Effect of Aromatherapy in Laparoscopic Cholecystectomy Patients

NCT ID: NCT05464602

Last Updated: 2023-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-27

Study Completion Date

2022-05-12

Brief Summary

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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

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Conditions

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Cholecystectomy Aromatherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention group Lavender

Each patient in this group received inhalation aromatherapy of lavender oil.

Group Type EXPERIMENTAL

Intervention group Lavender

Intervention Type OTHER

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

Each patient in this group received inhalation aromatherapy of geranium oil.

Group Type EXPERIMENTAL

Intervention group Geranium

Intervention Type OTHER

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.

Control group

Each patient in this group did not receive any additional treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 Type 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.

Intervention Type OTHER

Other Intervention Names

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Lavender oil Geranium oil

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Seda Akutay

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Erciyes University

Kayseri, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 30057057 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25584799 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31987220 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26133206 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26051567 (View on PubMed)

Akutay S, Doner A, Ceyhan O, Baykan M, Saz A. Aromatherapy Improves Pain, Sleep and Physiological Parameters in Laparoscopic Cholecystectomy Patients: A Single-Blind, Parallel Group, and Randomized Controlled Trial. Chin J Integr Med. 2025 Jun 10. doi: 10.1007/s11655-025-3823-z. Online ahead of print.

Reference Type DERIVED
PMID: 40490599 (View on PubMed)

Other Identifiers

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Erciyessbf

Identifier Type: -

Identifier Source: org_study_id

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