AnxietyNCT07067424
Effect of Aromatherapy on Anxiety in Colonoscopy Patients
A study testing Lavender Aromatherapy and Bergamot Aromatherapy in people with Anxiety and Colonoscopy, run by Eastern Mediterranean University at 1 site in Cyprus.
Trial summary
The aim of this study is to investigate the effects of aromatherapy with lavender and bergamot essential oils on anxiety, vital signs, and feelings of embarrassment before colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Colonoscopy, Aromatherapy
- What is being tested?
- Lavender Aromatherapy and Bergamot Aromatherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Jan 2025to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age
- Patients undergoing a colonoscopy
- Patients capable of reading and understanding the study instructions
Who cannot join
- Patients who refused to participate in the study
- Patients who reported an allergy to any of the lavender or bergamot extracts used in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cyprus1 site, 1 recruiting
- Recruiting
Famagusta State Hospital
Famagusta, 99450
Cemal Cevheroglu, Dr., 05488867788, info.gmdh@gov.ct.tr
Şerife Ünal, RN, 05338585829, info.gmdh@gov.ct.tr
About this study
Official title: The Effect of Lavender and Bergamot Aromatherapy Before Colonoscopy on Anxiety, Vital Signs, and Feelings of Embarrassment"
The aim of this study is to investigate the effects of aromatherapy with lavender and bergamot essential oils on anxiety, vital signs, and feelings of embarrassment before colonoscopy. The findings of this study are expected to contribute both to filling a gap in the literature and to the planning of evidence-based nursing interventions aimed at minimizing pre-colonoscopy anxiety and embarrassment in patients.
Read the detailed description
In addition to being a painful and uncomfortable procedure, colonoscopy can cause anxiety and fear in patients due to procedure-related concerns, fear of a cancer diagnosis, and feelings of embarrassment resulting from perceived violations of privacy during the procedure. To alleviate patients' anxiety, fear, or embarrassment before colonoscopy, various non-pharmacological approaches, such as aromatherapy, are utilized. Aromatherapy, also known as essential oil therapy, is defined as "the art and science of using naturally extracted aromatic essences from plants to balance, harmonize, and promote the health of the body, mind, and spirit". Lavender and bergamot essential oils have been reported to have positive effects on anxiety in patients undergoing certain medical procedures, such as surgeries, childbirth, urodynamic testing, and endoscopic interventions. However, no study has yet evaluated the combined effects of aromatherapy with lavender and bergamot oils on anxiety, vital signs, and feelings of embarrassment in patients undergoing colonoscopy. The aim of this study is to investigate the effects of aromatherapy with lavender and bergamot essential oils on anxiety, vital signs, and feelings of embarrassment before colonoscopy. The findings of this study are expected to contribute both to filling a gap in the literature and to the planning of evidence-based nursing interventions aimed at minimizing pre-colonoscopy anxiety and embarrassment in patients.
- Conditions
- Anxiety, Colonoscopy, Aromatherapy
- Being tested
- Lavender Aromatherapy, Bergamot Aromatherapy, Placebo Inhalation
- Keywords
- Lavender, Bergamot, Anxiety, Colonoscopy, Embarrassment
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lavender AromatherapyOther
Participants will inhale lavender essential oil via cotton pads placed near the nose for 20 minutes prior to colonoscopy. The application will take place in a pre-procedure waiting area under nurse supervision.
Bergamot AromatherapyOther
Participants will inhale bergamot essential oil through cotton pads placed near the nose for 20 minutes before the colonoscopy procedure, under the supervision of clinical staff.
Placebo InhalationOther
Participants will inhale an odorless substance (distilled water) using the same method and duration as the intervention groups, to simulate the aromatherapy procedure.
| Study group | Role | What they receive |
|---|---|---|
| Lavender Aromatherapy | Experimental | Inhalation of lavender essential oil for 20 minutes prior to colonoscopy. Receives: Other: Lavender Aromatherapy |
| Bergamot Aromatherapy | Experimental | Inhalation of bergamot essential oil for 20 minutes prior to colonoscopy. Receives: Other: Bergamot Aromatherapy |
| Control Group | Placebo comparator | Participants in this group will inhale an odorless substance (distilled water ) to mimic the aromatherapy procedure without active ingredients. Receives: Other: Placebo Inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety level measured by the State Anxiety Inventory (STAI-State)
Anxiety will be assessed using the State Anxiety Inventory (STAI-State), which consists of 20 items rated on a 4-point Likert scale. The total score ranges from 20 to 80, with higher scores indicating greater anxiety. The scale has been validated in Turkish with a Cronbach's alpha between 0.94 and 0.96.
Measured: Immediately before and 30 minutes after the intervention
Secondary outcomes (1)
Change in embarrassment level measured by the Colonoscopy Embarrassment Scale
Embarrassment related to colonoscopy will be measured using the 15-item Colonoscopy Embarrassment Scale, with scores ranging from 15 to 60. Higher scores indicate greater embarrassment. The Turkish version has a Cronbach's alpha of 0.94.
Measured: Immediately after the colonoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Jan 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ERAY YÜCEDAĞ, Eastern Mediterranean University
- Investigators
- Eray Yucedag, MSc Student, Principal investigator, Eastern Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067424
- Sponsor's protocol ID
- EY-Aroma2025-01
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yue QQ, Feng GH, Peng T, Tang T, Sun YX, Meng XR, Huang LL, Zhao KH, Huang HL, Zeng Y. What is the current state of anxiety and its related factors in Chinese patients undergoing colonoscopy? A cross-sectional study. BMC Psychol. 2025 Feb 27;13(1):169. doi: 10.1186/s40359-025-02463-z.
PubMed 40016795Peng W, McKinnon-Crowley J, Huang Q, Mao B. Assessing Fear, Embarrassment, and Disgust in Colonoscopy: The Development of Measurement Instruments and Psychometric Evidence. Health Educ Behav. 2024 Aug;51(4):601-612. doi: 10.1177/10901981231177075. Epub 2023 Jun 9.
PubMed 37293778Mutlu S, Yilmaz E, Sahin ST. The effect of position change and abdominal massage on anxiety, pain and distension after colonoscopy: A randomized clinical trial. Explore (NY). 2024 Jan-Feb;20(1):89-94. doi: 10.1016/j.explore.2023.06.007. Epub 2023 Jun 20.
PubMed 37391282Dogan Yilmaz E, Unlusoy Dincer N. The Effects of Virtual Reality Glasses on Vital Signs and Anxiety in Patients Undergoing Colonoscopy: A Randomized Controlled Trial. Gastroenterol Nurs. 2023 Jul-Aug 01;46(4):318-328. doi: 10.1097/SGA.0000000000000733. Epub 2023 Jun 5.
PubMed 37278621Honig AJ, Galassi MG, Ogungbe OO, Uranga T, Cuevas DK. Implementation of Aromatherapy, a Nonpharmacological Intervention, to Reduce Anxiety During the Preoperative Period. J Perianesth Nurs. 2023 Apr;38(2):206-212. doi: 10.1016/j.jopan.2022.06.011. Epub 2023 Feb 1.
PubMed 36732122Kettas Dolek E, Altun Ugras G. The effect of aromatherapy during urodynamic testing on patients anxiety and cortisol levels: A randomized controlled trial. Neurourol Urodyn. 2024 Sep;43(7):1591-1599. doi: 10.1002/nau.25491. Epub 2024 May 15.
PubMed 38747020Ni CH, Hou WH, Kao CC, Chang ML, Yu LF, Wu CC, Chen C. The anxiolytic effect of aromatherapy on patients awaiting ambulatory surgery: a randomized controlled trial. Evid Based Complement Alternat Med. 2013;2013:927419. doi: 10.1155/2013/927419. Epub 2013 Dec 17.
PubMed 24454517Keser E, Baglama SS, Sezer C. The Effect of Reiki and Aromatherapy on Vital Signs, Oxygen Saturation, and Anxiety Level in Patients Undergoing Upper Gastrointestinal Endoscopy: A Randomized Controlled Study. Holist Nurs Pract. 2023 Nov-Dec 01;37(6):337-346. doi: 10.1097/HNP.0000000000000611.
PubMed 37851350Pasyar N, Rambod M, Araghi F. The effect of bergamot orange essence on anxiety, salivary cortisol, and alpha amylase in patients prior to laparoscopic cholecystectomy: A controlled trial study. Complement Ther Clin Pract. 2020 May;39:101153. doi: 10.1016/j.ctcp.2020.101153. Epub 2020 Mar 21.
PubMed 32379683Hedigan F, Sheridan H, Sasse A. Benefit of inhalation aromatherapy as a complementary treatment for stress and anxiety in a clinical setting - A systematic review. Complement Ther Clin Pract. 2023 Aug;52:101750. doi: 10.1016/j.ctcp.2023.101750. Epub 2023 Apr 5.
PubMed 37031643Sayilan S, Sayilan AA, Mert S, Oztekin SD, Baydemir C. The Effect of Precolonoscopy Lavender Inhalation on Patient Anxiety and Comfort: A Randomized, Controlled, Double-Blinded, Single-Center Study. Gastroenterol Nurs. 2023 Sep-Oct 01;46(5):376-385. doi: 10.1097/SGA.0000000000000754. Epub 2023 Jun 8.
PubMed 37289849Vora LK, Gholap AD, Hatvate NT, Naren P, Khan S, Chavda VP, Balar PC, Gandhi J, Khatri DK. Essential oils for clinical aromatherapy: A comprehensive review. J Ethnopharmacol. 2024 Aug 10;330:118180. doi: 10.1016/j.jep.2024.118180. Epub 2024 Apr 16.
PubMed 38614262Shirzad M, Nasiri E, Hesamirostami M, Akbari H. The Effect of Lavender on Anxiety and Hemodynamic Status Before Septorhinoplasy and Rhinoplasty. J Perianesth Nurs. 2023 Feb;38(1):45-50. doi: 10.1016/j.jopan.2022.05.067. Epub 2022 Aug 18.
PubMed 35987997
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lavender and Bergamot Aromatherapy Before Colonoscopy on Anxiety, Vital Signs, and Feelings of Embarrassment"
- ClinicalTrials.gov ID
- NCT07067424
- Acronym / sponsor ID
- EY-Aroma2025-01
- Conditions
- Anxiety, Colonoscopy, Aromatherapy
- Keywords
- Lavender, Bergamot, Anxiety, Colonoscopy, Embarrassment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 16 Jul 2025 (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.
The aim of this study is to investigate the effects of aromatherapy with lavender and bergamot essential oils on anxiety, vital signs, and feelings of embarrassment before colonoscopy. The findings of this study are expected to contribute both to filling a gap in the literature and to the planning of evidence-based nursing interventions aimed at minimizing pre-colonoscopy anxiety and embarrassment in patients.
Detailed description
In addition to being a painful and uncomfortable procedure, colonoscopy can cause anxiety and fear in patients due to procedure-related concerns, fear of a cancer diagnosis, and feelings of embarrassment resulting from perceived violations of privacy during the procedure. To alleviate patients' anxiety, fear, or embarrassment before colonoscopy, various non-pharmacological approaches, such as aromatherapy, are utilized. Aromatherapy, also known as essential oil therapy, is defined as "the art and science of using naturally extracted aromatic essences from plants to balance, harmonize, and promote the health of the body, mind, and spirit". Lavender and bergamot essential oils have been reported to have positive effects on anxiety in patients undergoing certain medical procedures, such as surgeries, childbirth, urodynamic testing, and endoscopic interventions. However, no study has yet evaluated the combined effects of aromatherapy with lavender and bergamot oils on anxiety, vital signs, and feelings of embarrassment in patients undergoing colonoscopy. The aim of this study is to investigate the effects of aromatherapy with lavender and bergamot essential oils on anxiety, vital signs, and feelings of embarrassment before colonoscopy. The findings of this study are expected to contribute both to filling a gap in the literature and to the planning of evidence-based nursing interventions aimed at minimizing pre-colonoscopy anxiety and embarrassment in patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lavender Aromatherapy | Experimental | Other: Lavender AromatherapyInhalation of lavender essential oil for 20 minutes prior to colonoscopy. |
| Bergamot Aromatherapy | Experimental | Other: Bergamot AromatherapyInhalation of bergamot essential oil for 20 minutes prior to colonoscopy. |
| Control Group | Placebo comparator | Other: Placebo InhalationParticipants in this group will inhale an odorless substance (distilled water ) to mimic the aromatherapy procedure without active ingredients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients over 18 years of age
- Patients undergoing a colonoscopy
- Patients capable of reading and understanding the study instructions
Key exclusion criteria (2 listed)
- Patients who refused to participate in the study
- Patients who reported an allergy to any of the lavender or bergamot extracts used in the study
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 |
|---|---|---|
| Lavender AromatherapyParticipants will inhale lavender essential oil via cotton pads placed near the nose for 20 minutes prior to colonoscopy. The application will take place in a pre-procedure waiting area under nurse supervision. | Other | Lavender Aromatherapy |
| Bergamot AromatherapyParticipants will inhale bergamot essential oil through cotton pads placed near the nose for 20 minutes before the colonoscopy procedure, under the supervision of clinical staff. | Other | Bergamot Aromatherapy |
| Placebo InhalationParticipants will inhale an odorless substance (distilled water) using the same method and duration as the intervention groups, to simulate the aromatherapy procedure. | Other | Control Group |
Primary outcome
Change in anxiety level measured by the State Anxiety Inventory (STAI-State)
Time frame: Immediately before and 30 minutes after the intervention
Anxiety will be assessed using the State Anxiety Inventory (STAI-State), which consists of 20 items rated on a 4-point Likert scale. The total score ranges from 20 to 80, with higher scores indicating greater anxiety. The scale has been validated in Turkish with a Cronbach's alpha between 0.94 and 0.96.
1 secondary outcome
Change in embarrassment level measured by the Colonoscopy Embarrassment Scale
Time frame: Immediately after the colonoscopy procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Results publication: PubMed 40016795Yue QQ, Feng GH, Peng T, Tang T, Sun YX, Meng XR, Huang LL, Zhao KH, Huang HL, Zeng Y. What is the current state of anxiety and its related factors in Chinese patients undergoing colonoscopy? A cross-sectional study. BMC Psychol. 2025 Feb 27;13(1):169. doi: 10.1186/s40359-025-02463-z.
- Results publication: PubMed 37293778Peng W, McKinnon-Crowley J, Huang Q, Mao B. Assessing Fear, Embarrassment, and Disgust in Colonoscopy: The Development of Measurement Instruments and Psychometric Evidence. Health Educ Behav. 2024 Aug;51(4):601-612. doi: 10.1177/10901981231177075. Epub 2023 Jun 9.
- Results publication: PubMed 37391282Mutlu S, Yilmaz E, Sahin ST. The effect of position change and abdominal massage on anxiety, pain and distension after colonoscopy: A randomized clinical trial. Explore (NY). 2024 Jan-Feb;20(1):89-94. doi: 10.1016/j.explore.2023.06.007. Epub 2023 Jun 20.
- Results publication: PubMed 37278621Dogan Yilmaz E, Unlusoy Dincer N. The Effects of Virtual Reality Glasses on Vital Signs and Anxiety in Patients Undergoing Colonoscopy: A Randomized Controlled Trial. Gastroenterol Nurs. 2023 Jul-Aug 01;46(4):318-328. doi: 10.1097/SGA.0000000000000733. Epub 2023 Jun 5.
- Results publication: PubMed 36732122Honig AJ, Galassi MG, Ogungbe OO, Uranga T, Cuevas DK. Implementation of Aromatherapy, a Nonpharmacological Intervention, to Reduce Anxiety During the Preoperative Period. J Perianesth Nurs. 2023 Apr;38(2):206-212. doi: 10.1016/j.jopan.2022.06.011. Epub 2023 Feb 1.
- Results publication: PubMed 38747020Kettas Dolek E, Altun Ugras G. The effect of aromatherapy during urodynamic testing on patients anxiety and cortisol levels: A randomized controlled trial. Neurourol Urodyn. 2024 Sep;43(7):1591-1599. doi: 10.1002/nau.25491. Epub 2024 May 15.
- Results publication: PubMed 24454517Ni CH, Hou WH, Kao CC, Chang ML, Yu LF, Wu CC, Chen C. The anxiolytic effect of aromatherapy on patients awaiting ambulatory surgery: a randomized controlled trial. Evid Based Complement Alternat Med. 2013;2013:927419. doi: 10.1155/2013/927419. Epub 2013 Dec 17.
- Results publication: PubMed 37851350Keser E, Baglama SS, Sezer C. The Effect of Reiki and Aromatherapy on Vital Signs, Oxygen Saturation, and Anxiety Level in Patients Undergoing Upper Gastrointestinal Endoscopy: A Randomized Controlled Study. Holist Nurs Pract. 2023 Nov-Dec 01;37(6):337-346. doi: 10.1097/HNP.0000000000000611.
- Results publication: PubMed 32379683Pasyar N, Rambod M, Araghi F. The effect of bergamot orange essence on anxiety, salivary cortisol, and alpha amylase in patients prior to laparoscopic cholecystectomy: A controlled trial study. Complement Ther Clin Pract. 2020 May;39:101153. doi: 10.1016/j.ctcp.2020.101153. Epub 2020 Mar 21.
- Results publication: PubMed 37031643Hedigan F, Sheridan H, Sasse A. Benefit of inhalation aromatherapy as a complementary treatment for stress and anxiety in a clinical setting - A systematic review. Complement Ther Clin Pract. 2023 Aug;52:101750. doi: 10.1016/j.ctcp.2023.101750. Epub 2023 Apr 5.
- Results publication: PubMed 37289849Sayilan S, Sayilan AA, Mert S, Oztekin SD, Baydemir C. The Effect of Precolonoscopy Lavender Inhalation on Patient Anxiety and Comfort: A Randomized, Controlled, Double-Blinded, Single-Center Study. Gastroenterol Nurs. 2023 Sep-Oct 01;46(5):376-385. doi: 10.1097/SGA.0000000000000754. Epub 2023 Jun 8.
- Results publication: PubMed 38614262Vora LK, Gholap AD, Hatvate NT, Naren P, Khan S, Chavda VP, Balar PC, Gandhi J, Khatri DK. Essential oils for clinical aromatherapy: A comprehensive review. J Ethnopharmacol. 2024 Aug 10;330:118180. doi: 10.1016/j.jep.2024.118180. Epub 2024 Apr 16.
- Individual participant dataSharing planned: No
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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.
Eray Yucedag, MSc Student principal investigator
Eastern Mediterranean University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lavender Aromatherapy and Bergamot Aromatherapy in people with Anxiety and Colonoscopy, run by Eastern Mediterranean University at 1 site in Cyprus.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 16 Jul 2025. 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 Cyprus. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eray Yucedag, MSc student (05428884948, eray_ycedag@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety level measured by the State Anxiety Inventory (STAI-State) (time frame: Immediately before and 30 minutes after the intervention). 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 NCT07067424, which also lists 13 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 16 Jul 2025.