Evaluation effects of aromatherapy with Rosa Damascena on anxiety of mothers with premature infants admitted to the neonatal intensive care unit (NICU)
Determining effects of aromatherapy with Rosa Damascena on anxiety of mothers with premature infants admitted to the neonatal intensive care unit
Design
A clinical trial with a control group, with factorial groups, non-randomized and without blinding (open-label), phase 3
on 80 mothers who have premature babies
Settings and conduct
After obtaining informed consent from mothers with premature infants, Mahdieh Hospital is randomly divided into two groups of intervention and control. The methodology will be a parallel clinical trial. The subjects in the intervention group received aromatherapy with 10% rosemary essential oil for 10 nights 20 minutes before bedtime as it was poured on 2 * 2 cotton, while the control group did not receive any intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria
• Mothers aged 18-45 years
• Being able and willing to respond
• Satisfaction to participate in the study
• Has a premature baby admitted to the neonatal intensive care unit of the hospital
• Having anxiety
Exclusion criteria
• Whenever a mother gives up from participating in the study after entering the study
• Whenever a baby dies for any reason during the study
• Headache, infection, and bleeding after the start of the study that requires medical intervention History of any allergies to Rosa Damascena
• History of any drug allergies
• Have a history of allergies to herbal medicines
• A mother takes medicine to relieve anxiety
• A mother uses non-pharmacological methods such as meditation, yoga, acupuncture to relieve anxiety
Intervention groups
Intervention group: Aromatherapy with 10% essential oil of Damask rose, 5 drops, 10 nights + routine recommendations
Control group: Only routine recommendations
Main outcome variables
anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201012049007N1
Registration date:2021-07-11, 1400/04/20
Registration timing:prospective
Last update:2021-07-11, 1400/04/20
Update count:0
Registration date
2021-07-11, 1400/04/20
Registrant information
Name
Fatemeh Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5366
Email address
fatemehashemi2075@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation effects of aromatherapy with Rosa Damascena on anxiety of mothers with premature infants admitted to the neonatal intensive care unit (NICU)
Public title
Effects of aromatherapy with Rosa Damascena on anxiety of mothers with premature infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers aged 18-45 years
Ability and willingness to participate in the study
Satisfaction to participate in the study
Has a premature baby admitted to the neonatal intensive care unit of Mahdieh Hospital in Tehran
Having anxiety (with any score)
Exclusion criteria:
Whenever a mother gives up from participating in the study after entering the study
Whenever a baby dies for any reason during the study
Headache, infection and bleeding after the start of the study that requires medical intervention
History of any allergies to Rosa Damascena
History of any drug allergies (according to the mother statement)
Have a history of allergies to herbal medicines (according to the mother statement)
A mother takes medicine to relieve anxiety (according to the mother statement)
A mother uses non-pharmacological methods such as meditation, yoga, acupuncture to relieve anxiety (according to the mother statement)
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Ethics Committee in Research, Vice Chancellor for Research and Technology, Shahid Beheshti Universit
Street address
Tehran, Vali Asr St., Niayesh intersection, in front of Shahid Rajaei Heart Hospital, School of Nursing and Midwifery
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2021-06-13, 1400/03/23
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.115
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Anxiety score in Spielberger questionnaire
Timepoint
Before the intervention, after 10 days
Method of measurement
Spielberger Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For 10 nights, aromatherapy with 10% Damasak rose essence, 20 minutes before going to bed, 5 drops of it is poured on a piece of 2 * 2 pieces of cotton and inhale for 5-10 minutes. Also, routine recommendations (such as not using electronic devices and cyberspace from 2 hours before bedtime, taking deep breaths, not eating heavy food, ...) will be explained.
Category
Treatment - Drugs
2
Description
Control group: Only routine recommendations (such as not using electronic devices and cyberspace from 2 hours before bedtime, taking deep breaths, not eating heavy food, ...) will be explained and there is no drug intervention.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Mahdiye Hospital
Full name of responsible person
Fares Najari
Street address
Rajabnia Ave, Fadayian Eslam St, Shoosh Sq
City
Tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
mahdiyeh_hospital@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Rasool Choopani
Street address
No. 19, Shahid Abbaspour Bridge (Tavanir), Vali Asr Ave. Tehran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3523
Fax
Email
rasoolchoopani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Hashemi
Position
Msc Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Tehran, Vali Asr St., Niayesh intersection, in front of Shahid Rajaei Heart Hospital, School of Nursing and Midwifery
City
TEHRAN
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
fatemehashemi2075@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Ghazaleh Heydarirad
Position
MD.PHD
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No.8 Shams Alley, Opposite Sttree Tavanir, Vali Asr Street, Tehran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3523
Email
dr.ghazalrad@sbmu.ac.ir
Web page address
http://traditional.sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fatemeh Hashemi
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Niyayesh blv shahid beheshti univercity Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
Email
fatemehashemi2075@sbmu.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
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