1. Home
  2. Approved trials
  3. » فارسی

Compare the effect of aromatherapy with Citrus aurantium and music on the level of anxiety and physiological indexes in patients undergoing colonoscopy

Protocol summary

Study aim
Compare the effect of aromatherapy with Citrus aurantium( neroli oil) and music on the level of anxiety and physiological indexes in patients undergoing colonoscopy
Design
A randomized clinical trial study was conducted in three groups (control and two test groups), with parallel, randomized groups
Settings and conduct
The sample size will be 90 patients whom randomly assigned to three groups ( two intervention groups and one control group).
Participants/Inclusion and exclusion criteria
Inclusion criteria: age of 18-65 years old; without history of mental illnesses, headacheas, migraines, asthma, heart disease,respiratory disease and olfactory dysfunction, allergy to the odor of plants specially plants of Citrus aurantium, the first experience of colonoscopy;willingness to participant in the study, ability to speak and comprehend Persian; being conscious,Do not take anti-anxiety drugs. Exclusion criteria: refuse to continue corporation in this study, cancellation of colonoscopy procedure on the scheduled day, outbreak of problems such as headaches that cause interruption of the intervention.
Intervention groups
There is no intervention for patients and they will receive routine nursing care. In the experimental group (1): At once, by using a dropper two drops of Citrus aurantium were poured on the 2 * 2 gases and attached to the collar of patients Then, asked them to inhald for 30 min. In the experimental group (2): Music is being played out using headphones for 30 min.
Main outcome variables
Anxiety Level and Physiological Indexes(Blood pressure, Heart rate, Respiration rate)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170124032147N5
Registration date: 2018-07-25, 1397/05/03
Registration timing: retrospective

Last update: 2018-07-25, 1397/05/03
Update count: 0
Registration date
2018-07-25, 1397/05/03
Registrant information
Name
Bahareh Ghafourzadeh Toomatari
Name of organization / entity
Tehran university of medical scienc, School of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
b-ghafourzadeh@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
2018-01-10, 1396/10/20
Actual recruitment end date
2018-06-20, 1397/03/30
Trial completion date
empty
Scientific title
Compare the effect of aromatherapy with Citrus aurantium and music on the level of anxiety and physiological indexes in patients undergoing colonoscopy
Public title
Assessing the effect of aromatherapy with Citrus aurantium(neroli oil) and music on the level of anxiety and physiological indexes in patients undergoing colonoscopy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: age of 18-65 years old; without history of mental illnesses, headacheas, migraines, asthma, heart disease,respiratory disease and olfactory dysfunction, allergy to the odor of plants specially plants of Citrus aurantium, the first experience of colonoscopy; willingness to participant in the study, ability to speak and comprehend Persian; being conscious, Do not take anti-anxiety drugs
Exclusion criteria:
Exclusion criteria: refuse to continue corporation in this study, cancellation of colonoscopy procedure on the scheduled day, outbreak of problems such as headaches that cause interruption of the intervention.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 120
Actual sample size reached: 120
Randomization (investigator's opinion)
Randomized
Randomization description
The research samples were randomly assigned to the six-block questionnaire, which were performed by the software. Sixth permutations were determined using the three letters A for the control group, the letter B for the intervention group with music and the letter C for the intervention group with Citrus aurantium, and using the randomized method, six permutations in the triple groups were chosen
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Commitee of Tehran Factulty of Nursing and Midwifery and Rehabilitation
Street address
Tehran, Factulty of Nursing and Midwifery, Nosrat Sharghi, Tohid Square,
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2017-06-20, 1396/03/30
Ethics committee reference number
IR.TUMS.FNM.REC.1396.2699

Health conditions studied

1

Description of health condition studied
colon disease
ICD-10 code
K52.9
ICD-10 code description
Noninfective gastroenteritis and colitis, unspecified

Primary outcomes

1

Description
Anxiety
Timepoint
in the morning of the day of colonoscopy prior to the intervention, immediately after the intervention, and immediately before colonoscopy
Method of measurement
Visual Analog Scale questionnaire

2

Description
Heart rate
Timepoint
in the morning of the day of colonoscopy prior to the intervention, immediately after the intervention, and immediately before colonoscopy( after theintervention)
Method of measurement
Radial puls count through touch

3

Description
Respiration rate
Timepoint
in the morning of the day of colonoscopy prior to the intervention, immediately after the intervention, and immediately before colonoscopy( after theintervention)
Method of measurement
Enumeration

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: The method of intervention were done as: On the morning of the procedure, before the intervention, the level of anxiety and physiological indices are measured. Then, 2 drops of essential oil are stained with 2 * 2 gases and attached to the collar of the patients and continue for half an hour, and then the level of anxiety and physiological indicators immediately after the end of aromatherapy and again immediately before colonoscopy and before Sedative infusion is measured.
Category
Other

2

Description
Second intervention group: The method of intervention were done as: On the morning of the procedure, before the intervention, the level of anxiety and physiological indices are measured. Then the indomitable music (called relaxing music by Dr. Arendestein called Relaxation in Dream) is broadcast to the patient for half an hour using the headphones, after the intervention, also immediately before the procedure, the level of anxiety and physiological parameters of the size Is measured.
Category
Other

3

Description
Control group: In the control group, no interventions are performed on patients and they will receive routine nursing care.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rohani Hospital
Full name of responsible person
Saeede Rostami Daronkola
Street address
Rohani Hospital, Keshavarz Boulevard, University Square, Babol
City
Babol
Province
Mazandaran
Postal code
4713965365
Phone
+98 11 3231 6406
Email
rostamisaeede@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Massoud Younesian
Street address
Beginning of Ghods Ave., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 11 3231 6406
Email
rostamisaeede@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Saeede Rostami Daronkola
Position
Master's degree in Internal Surgery Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
(Nusrat East) Dr. Mirmohani Ave., Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 11 3231 6406
Email
rostamisaeede@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saeede Rostami Daronkola
Position
Master's degree in Internal Surgery Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nusrat East Ave., Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 11 3231 6406
Email
rostamisaeede@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Saeede Rostami Daronkola
Position
Master's degree in Internal Surgery Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nusrat East Ave., Tohid Square
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 11 3231 6406
Email
rostamisaeede@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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...