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Comparison of the effect of aromatherapy with Narcissus flower and Lavender on anxiety and some vital signs of mothers of hospitalized children with burn

Protocol summary

Study aim
Determining and comparison of the effect of aromatherapy with Narcissus flower and Lavender on anxiety and some vital signs of mothers of hospitalized children with burn
Design
Parallel group randomized clinical trial in which participants will be divided in to 3 groups by permuted block randomization . Sample size was calculated 45.
Settings and conduct
All interested mothers of hospitalized children in Amiralmomenin burning hospital will be invited to participate in the study. Eligible participants enter the study. Participants are then randomly assigned to 3 groups. First, their anxiety level and vital signs will be measured and recorded.Then the intervention will be done. At the end, vital signs and anxiety will be measured again and compared with previous data.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Mothers of hospitalized burned children, able to read and write, negative history of allergy to aromatic substances, not using other methods for reducing anxiety, being able to talk and understand Persian 6-Not having olfactory disorders, negative history of migraine, cardiopulmonary disease or chronic mental disorder, not having severe activity, exercise, smoking or any factor effecting vital signs 30 minutes before checking vital signs, not taking drugs that affect vital signs Exclusion criteria: Sudden allergic reactions, Worsening the child condition or child death, Note having desire to continue, Incomplete completion of the questionnaire
Intervention groups
Intervention groups will inhale 5 drops of Narcissus or Lavender essential oil poured on the gas at a distance of 10 cm from the nose for 15 minutes and the control group with the same condition will inhale odorless biter almonds .
Main outcome variables
Vital signs(pulse, respiration, blood pressure), anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190727044347N4
Registration date: 2021-08-04, 1400/05/13
Registration timing: prospective

Last update: 2021-08-04, 1400/05/13
Update count: 0
Registration date
2021-08-04, 1400/05/13
Registrant information
Name
Fatemeh Shirazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
shirazifa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of aromatherapy with Narcissus flower and Lavender on anxiety and some vital signs of mothers of hospitalized children with burn
Public title
Comparison of the effect of aromatherapy with Narcissus flower and Lavender on anxiety and some vital signs of mothers of children with burn
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers of burned hospitalized children Being able to read and write Not having allergy to aromatic substances Not using the other ways for reducing anxiety Being able to talk and understand Persian Not having olfactory disorder Negative history of migraine, cardiopulmonary disease or chronic mental disorder Not having severe activity, exercise, smoking or any factor affecting vital signs 30 minutes before checking vital signs Not taking drugs that affect pulse, respiration and blood pressure
Exclusion criteria:
sudden allergic reactions worsening the child condition or child death Not having desire to continue Incomplete completion of the questionnaire
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting eligible individuals to participate in the study, based on inclusion criteria, these individuals will be assigned to two study groups based on double randomized permutation block. The random list will be generated by a statistician using "Random Allocation" software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Shiraz University of Medical Sciences
Street address
Vice-Chancellor for Research, Shiraz university of medical sciences, Zand Blvd
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2021-07-07, 1400/04/16
Ethics committee reference number
IR.SUMS.REC.1400.355

Health conditions studied

1

Description of health condition studied
Mothers of hospitalized children with burn
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Anxiety
Timepoint
Before and after intervention
Method of measurement
Spielberger Anxiety Scale

2

Description
Pulse
Timepoint
Before and after intervention
Method of measurement
Using digital blood pressure monitor

3

Description
Blood pressure
Timepoint
Before and after intervention
Method of measurement
Using digital blood pressure monitor

4

Description
Respiratory rate
Timepoint
Before and after intervention
Method of measurement
Counting by researcher

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: Half to one hour before change dressing of burned children, the researcher will pour 5 drops of of Angostifolia lavender essential oil (100% concentration) on a piece of gas and the mothers of the children will hold that gas at a distance of about 10 cm from their nose and smell it for 15 minutes.
Category
Treatment - Other

2

Description
Half to one hour before change dressing of burned children, the researcher will pour 5 drops of of Narcissus essential oil (100% concentration) on a piece of gas and the mothers of the children will hold that gas at a distance of about 10 cm from their nose and smell it for 15 minutes.
Category
Treatment - Other

3

Description
Half to one hour before change dressing of burned children, the researcher will pour 5 drops of odorless bitter almond oil on a piece of gas and the mothers of the children will hold that gas at a distance of about 10 cm from their nose and smell it for 15 minutes.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralmomenin(AS) burn hospital
Full name of responsible person
Dr . Mohammad Mehdi Aslani
Street address
Sadra town
City
Shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3614 6101
Fax
+98 71 3622 0437
Email
amiralmomeninbh@sums.ac.ir
Web page address
https://amiralmomeninbh.sums.ac.ir/?sub=32

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Abbas Rezaianzade
Street address
Vice-Chancellor for research, Shiraz University of Medical Science, Zand Blvd
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Shirazi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Namazi Square, Namazi Hospital
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
shirazi_1393@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Shirazi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of nursing and midwifery, Namazi hospital, Namazi square
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
shirazi_1393@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Shirazi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and midwifery,Namazi hospital, Namazi square
City
Shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
Shirazi_1393@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Not applicable
Data Dictionary
Not applicable
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