NCT05464602

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 14, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

4 months

First QC Date

June 14, 2022

Last Update Submit

September 6, 2023

Conditions

CholecystectomyAromatherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The Richards-Campbell Sleep Questionnaire

    change from baseline score at the end of three day

Other Outcomes (4)

  • Physiological parameter (Blood Pressure)

    change from baseline score at the end of three day

  • Physiological parameter(Heart rate)

    change from baseline score at the end of three day

  • Physiological parameter(Respiratory rate)

    change from baseline score at the end of three day

  • +1 more other outcomes

Study Arms (3)

Intervention group Lavender

EXPERIMENTAL

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

Other: Intervention group Lavender

Intervention group Geranium

EXPERIMENTAL

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

Other: Intervention group Geranium

Control group

NO INTERVENTION

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

Interventions

Intervention group LavenderOTHER

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.

Also known as: Lavender oil
Intervention group Lavender
Intervention group GeraniumOTHER

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.

Also known as: Geranium oil
Intervention group Geranium

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erciyes University

Kayseri, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 30057057BACKGROUND

  • 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.

    PMID: 25584799BACKGROUND

  • 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.

    PMID: 31987220BACKGROUND

  • 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.

    PMID: 26133206BACKGROUND

  • 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.

    PMID: 26051567BACKGROUND

  • 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.

    PMID: 40490599DERIVED

MeSH Terms

Interventions

lavender oil

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 14, 2022

First Posted

July 19, 2022

Study Start

January 27, 2022

Primary Completion

May 12, 2022

Study Completion

May 12, 2022

Last Updated

September 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

There is no plan

Locations

TU(1)