The purpose of this study was to investigate the effect of inhalation of chamomile essential oil on nausea in endoscopic candidates patients.
Design
This study is a clinical trial with two group. The population will be grouped by random assignment. Sample size for each group is 80 (160 persons in total), and the sampling is continued until the target population is reached.
Settings and conduct
The aim of this study was to investigate the effect of chamomile essential oil on the anxiety of endoscopic candidate patients in the endoscopic ward of Sabzevar Vasei Hospital. The study is done double-blind. Blindness is that the subjects patients are unaware of being in the intervention or control group. Data is also encoded, and are given to the statistician without any specific intervention or control group.
Participants/Inclusion and exclusion criteria
inclusion: willing to participate in the study;Having a physician's order for doing of endoscopy ; healthy sense of smell and taste;aged between 18-70 years; able to understand and speak persian exclusion: History of taking anti-nausea drugs or with anti-nausea effects; addiction; Having nausea before endoscopy; pregnancy; Having a biopsy when needed during endoscopy; Use of sedative before endoscopy
Intervention groups
This study is done in two groups. In the intervention group, chamomile essential oil was inhaled and in the control group inhaled placebo, which in this study is sesame oil. Then, the effect of inhalation of these two substances on nausea in the two groups will be compared.
Main outcome variables
Nausea ؛ after of endoscopy ؛Visual analogue scale(VAS)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170515033977N2
Registration date:2018-09-06, 1397/06/15
Registration timing:registered_while_recruiting
Last update:2018-09-06, 1397/06/15
Update count:0
Registration date
2018-09-06, 1397/06/15
Registrant information
Name
Akram Gholami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5254 7291
Email address
akram.gh1369@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-05, 1397/06/14
Expected recruitment end date
2018-11-05, 1397/08/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of matricaria chamomile essential oil inhalation on nausea of patients after Esophagogastroduodenoscopy in mashhad
Public title
The effect ofmatricaria chamomile essential oil on nausea of Esophagogastroduodenoscopy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
willing to participate in the study
Having a doctor's order for upper gastrointestinal endoscopy
healthy sense of smell and taste
aged between 18-70 years
able to understand and speak persian
Exclusion criteria:
History of taking anti-nausea drugs or with anti-nausea effects(for example eskazina ,...) or nauseous drugs like Opiates، Ferrous sulfate،...
addiction
Having nausea before endoscopy
Being pregnant
Having a biopsy when needed during endoscopy
Use of sedative before endoscopy
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
The population of the study is randomly selected, so that the day of the sampling from the two groups of intervention and control will be determined by the lottery, and persons will not know which group they are in.
Blinding (investigator's opinion)
Double blinded
Blinding description
Sampling is easy and persons are unaware of being in the intervention or control group. After completion of the data sampling, the data will be collected and coded (code 1 and code 2 ) and then will be available to the statistician. Since the essential oil of Chamomile has a fragrance and a placebo without a fragrance, the sampler is aware of the groups. Therefore, can be said the double-blind trial.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Sabzevar University of Medical Sciences
Street address
the Central University of Medical Sciences- Street Asadabadi- Sabzevar
City
sabzevar
Province
Razavi Khorasan
Postal code
9613873119
Approval date
2018-08-24, 1397/06/02
Ethics committee reference number
IR.MEDSAB.REC.1397.027
Health conditions studied
1
Description of health condition studied
Endoscopic Nausea
ICD-10 code
T88.9
ICD-10 code description
Complication of surgical and medical care, unspecified
Primary outcomes
1
Description
Nausea score based on VAS scale
Timepoint
30 minutes later intervention and endoscopy
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, inhalation of 7 drops of essential oil of 10% chamomile produced by giah esans Gorgan Company. The essential oil is dipped on a sterilized gas and attached to the patient's collar of cloth.
Category
Other
2
Description
Control group: In this group, 7 drops of sesame oil produced by giah esans Gorgan Company will be given as a placebo by inhalation. In this way, the desired amount is poured on a sterilized gas with a dropper and attached to the cloth of the research unit, and 20 minutes inhalation will be performed, and then Patient endoscopy is done.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Vasei Hospital in Sabzevar
Full name of responsible person
Hasan Khalili
Street address
Tawhid shahr, Sabzevar Medical Science Campus
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873119
Phone
+98 51 4401 1000
Fax
+98 51 4401 1000
Email
khalili894@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Fereshte Ghorat
Street address
Research and Technology department, Sabzevar Medical Science Campus,Tawhid shahr
City
Sabzevar
Province
Razavi Khorasan
Postal code
9617913114
Phone
+98 51 4401 8319
Fax
+98 51 4401 8319
Email
Drghorat@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Torbate-Jam University of Medical Sciences
Full name of responsible person
Akram Gholami
Position
Nursing Education teacher
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 12. mirghavamedin Ave
City
Torbat jam
Province
Razavi Khorasan
Postal code
9198654331
Phone
+98 51 5252 4520
Fax
+98 51 5252 2791
Email
akram.gh1369@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Hasan Khalili
Position
Nursing Education teacher
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Sabzevar Medical Science Campus,Tohid shahr,
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873119
Phone
+98 51 4401 1000
Email
khalili894@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Torbate-Jam University of Medical Sciences
Full name of responsible person
Akram Gholami
Position
Nursing Education teacher
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 12, Mirghavamdin avnue
City
Torbat jam
Province
Razavi Khorasan
Postal code
9198654331
Phone
+98 51 5252 4520
Fax
Email
akram.gh1369@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available