CholecystectomyNCT05464602
The Effect of Aromatherapy in Laparoscopic Cholecystectomy Patients
A study testing Intervention group Lavender and Intervention group Geranium in people with Cholecystectomy and Aromatherapy, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholecystectomy, Aromatherapy
- What is being tested?
- Intervention group Lavender and Intervention group Geranium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jan 2022to 12 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Having any respiratory system disease (COPD, Asthma, etc.),
- Disturbed by the smell of essential oils,
- Any allergic diagnosis and history,
- Using anxiolytic, antidepressant,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cholecystectomy, Aromatherapy
- Being tested
- Intervention group Lavender, Intervention group Geranium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group LavenderOther
Also called Lavender oil
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 GeraniumOther
Also called Geranium oil
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group Lavender | Experimental | Each patient in this group received inhalation aromatherapy of lavender oil. Receives: Other: Intervention group Lavender |
| Intervention group Geranium | Experimental | Each patient in this group received inhalation aromatherapy of geranium oil. Receives: Other: Intervention group Geranium |
| Control group | No intervention | Each patient in this group did not receive any additional treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline score at the end of three day
Secondary outcomes (1)
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.
Measured: change from baseline score at the end of three day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start27 Jan 2022
- Primary completion12 May 2022
- Study completion12 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for CholecystectomyStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seda Akutay, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05464602
- Sponsor's protocol ID
- Erciyessbf
- Status last verified
- Sep 2023
- First submitted
- 14 Jun 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan
Publications
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.
PubMed 30057057Hwang 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.
PubMed 25584799Abdelhakim 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.
PubMed 31987220Lillehei 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.
PubMed 26133206Bikmoradi 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.
PubMed 26051567Akutay 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. 2026 Aug;32(8):685-692. doi: 10.1007/s11655-025-3823-z. Epub 2025 Jun 10.
PubMed 40490599
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aromatherapy on Postoperative Pain, Sleep Quality and Physiological Parameters in Laparoscopic Cholecystectomy Patients
- ClinicalTrials.gov ID
- NCT05464602
- Acronym / sponsor ID
- Erciyessbf
- Conditions
- Cholecystectomy, Aromatherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 27 Jan 2022 (actual)
- Primary completion
- 12 May 2022 (actual)
- Study completion
- 12 May 2022 (actual)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group Lavender | Experimental | Other: Intervention group LavenderEach patient in this group received inhalation aromatherapy of lavender oil. |
| Intervention group Geranium | Experimental | Other: Intervention group GeraniumEach patient in this group received inhalation aromatherapy of geranium oil. |
| Control group | No intervention | –Each patient in this group did not receive any additional treatment. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- Having any respiratory system disease (COPD, Asthma, etc.),
- Disturbed by the smell of essential oils,
- Any allergic diagnosis and history,
- Using anxiolytic, antidepressant,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention group LavenderAlso: Lavender oilThis 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 | Intervention group Lavender |
| Intervention group GeraniumAlso: Geranium oilThis 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 | Intervention group Geranium |
Primary outcome
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.
1 secondary outcome
The Richards-Campbell Sleep Questionnaire
Time frame: change from baseline score at the end of three day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Background: PubMed 30057057Saritas 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.
- Background: PubMed 25584799Hwang 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.
- Background: PubMed 31987220Abdelhakim 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.
- Background: PubMed 26133206Lillehei 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.
- Background: PubMed 26051567Bikmoradi 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.
- Derived from this study: PubMed 40490599Akutay 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. 2026 Aug;32(8):685-692. doi: 10.1007/s11655-025-3823-z. Epub 2025 Jun 10.
- Individual participant dataSharing planned: No. There is no plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group Lavender and Intervention group Geranium in people with Cholecystectomy and Aromatherapy, run by TC Erciyes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: change from baseline score at the end of three day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05464602, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.