The aim of this study is to investigate the effect of aromatherapy with lavender on anxiety and pain in colposcopy candidate patients
Design
A controlled, parallel, double-blind, randomized, phase 3 clinical trial on 110 patients who were divided into 2 groups using blocks of 4
Settings and conduct
This study will be conducted in Arash Women Hospital, Tehran, Iran. After dividing colposcopy candidate patients into intervention and control groups using a random block list, the patients will receive the intervention of napkins soaked in lavender scent or a placebo of napkins soaked in water. Only the external observer of the study will be aware of the allocation of subjects.
Participants/Inclusion and exclusion criteria
Patients candidate for colposcopy who aged 18-70, without chronic anxiety disorders, history of allergy to plants and sedative medication usage.
Intervention groups
Patients in the intervention group will smell lavender-scented napkins for 3 minutes.
.Patients in the control group will smell napkins soaked in water for 3 minutes.
Main outcome variables
Pain and anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240724062526N1
Registration date:2024-08-04, 1403/05/14
Registration timing:prospective
Last update:2024-08-04, 1403/05/14
Update count:0
Registration date
2024-08-04, 1403/05/14
Registrant information
Name
Akram Ghahghaei-Nezamabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7771 9922
Email address
aghahghaei@sina.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-09-05, 1403/06/15
Expected recruitment end date
2026-03-19, 1404/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with lavender on anxiety and pain in colposcopy candidate patients: a randomized clinical trial
Public title
The effect of aromatherapy with lavender on colposcopy health and pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients referred for colposcopy
Exclusion criteria:
Acute pain at the time of completing the questionnaire
Having psychiatric disorders including anxiety
Mental retardation
Blindness and deafness
History of eczema and allergies to plants
History of migraine and chronic headaches
Impaired sense of smell
Use of sedatives and narcotics
A history of severe mental stress around the time of colposcopy (such as the death of a loved one)
Age
From 18 years old to 70 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, to make sure that the same number of participants are allocated to both groups (lavender group and placebo group), block randomization with a block size of 4 with a 1:1 ratio will be used. A list of 4-person blocks will be created randomly using Stata 17.0 software. This makes the number of people in each group the same, unlike simple randomization, and the power of the study is maximum.
Blinding (investigator's opinion)
Double blinded
Blinding description
The scented napkins of both groups are the same, and the patient will not be informed of her assigned group, but she will be given the necessary and sufficient explanations regarding the random assignment to one of the groups along with the intervention that is performed in each group. Lavender-scented napkins and water-soaked napkins (placebo) will be prepared by one of the operating room personnel who is not in contact with others and will be provided to the interventionist. The midwife/doctor applying the intervention will not know about the patient group. Also, the midwife/physician who measures the outcomes will not know the patient allocation. The data analyst will also be blinded to the allocation of subjects.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Imam Khomeini Hospital Complex
Street address
Keshavarz Blvd., Intersection of Qods St., Central Building of Tehran University of Medical Sciences, 6th floor, Room 604
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2024-01-23, 1402/11/03
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.422
Health conditions studied
1
Description of health condition studied
Anxiety caused by colposcopy
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition