Brief 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. 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.

Trial Health

Monitor

Trial Health Score

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

Trial has exceeded expected completion date

Enrollment

102

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline

Completed

Started Jan 2025

Geographic Reach

1 country

1 active site

Status

recruiting

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

11 months study duration

Study Start

First participant enrolled

January 1, 2025

Completed

6 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2025

Completed

2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed

Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

10 months

First QC Date

July 14, 2025

Last Update Submit

July 15, 2025

Conditions

Anxiety Colonoscopy Aromatherapy

Keywords

LavenderBergamotAnxietyColonoscopyEmbarrassment

Outcome Measures

Primary Outcomes (1)

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.
Immediately before and 30 minutes after the intervention

Secondary Outcomes (1)

Change in embarrassment level measured by the Colonoscopy Embarrassment Scale
Immediately after the colonoscopy procedure

Other Outcomes (4)

Change in heart rate
Immediately before and 30 minutes after the intervention
Change in respiratory rate
Immediately before and 30 minutes after the intervention
Change in systolic and diastolic blood pressure
Immediately before and 30 minutes after the intervention
+1 more other outcomes

Study Arms (3)

Lavender Aromatherapy

EXPERIMENTAL

Inhalation of lavender essential oil for 20 minutes prior to colonoscopy.

Other: Lavender Aromatherapy

Bergamot Aromatherapy

EXPERIMENTAL

Inhalation of bergamot essential oil for 20 minutes prior to colonoscopy.

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.

Other: Placebo Inhalation

Interventions

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.

Lavender Aromatherapy

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.

Bergamot Aromatherapy

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.

Control Group

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients over 18 years of age
Patients undergoing a colonoscopy
Patients capable of reading and understanding the study instructions

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Eastern Mediterranean Universitylead

Study Sites (1)

Famagusta State Hospital

Famagusta, 99450, Cyprus

RECRUITING

Related Publications (13)

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.
PMID: 40016795RESULT
Peng 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.
PMID: 37293778RESULT
Mutlu 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.
PMID: 37391282RESULT
Dogan 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.
PMID: 37278621RESULT
Honig 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.
PMID: 36732122RESULT
Kettas 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.
PMID: 38747020RESULT
Ni 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.
PMID: 24454517RESULT
Keser 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.
PMID: 37851350RESULT
Pasyar 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.
PMID: 32379683RESULT
Hedigan 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.
PMID: 37031643RESULT
Sayilan 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.
PMID: 37289849RESULT
Vora 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.
PMID: 38614262RESULT
Shirzad 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.
PMID: 35987997RESULT

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

Eray Yucedag, MSc Student
Eastern Mediterranean University
PRINCIPAL INVESTIGATOR

Central Study Contacts

Eray Yucedag, MSc student

CONTACT

05428884948 eray_ycedag@icloud.com

Sevinc Tastan, Prof.

CONTACT

05488785465 sevinc.tastan@emu.edu.tr

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: OTHER
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Clinical Nurse

Study Record Dates

First Submitted

July 14, 2025

First Posted

July 16, 2025

Study Start

January 1, 2025

Primary Completion

October 31, 2025

Study Completion

November 30, 2025

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing: Will not share

Locations

CY(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Other Outcomes (4)

Study Arms (3)

Lavender Aromatherapy

Bergamot Aromatherapy

Control Group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (13)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Data Sharing

Locations