Determining the effect of lavender scent inhalation on fatigue and stress of mothers of premature babies
Design
Clinical trial with control group, with parallel groups, randomized, phase 3 on 72 patients, randomization by simple random method in the form of available sampling.
Settings and conduct
Mothers of premature babies in the intervention group inhaled a neck pendant containing cotton soaked with two drops of lavender essential oil at a distance of 20 cm from the nose for 30 minutes three times a week, every other day for 4 weeks. No aromatherapy is done for the control group. Both groups complete questionnaires measuring fatigue and stress before the start of the intervention, two weeks after the start of the intervention and 4 weeks after the start of the intervention.
Participants/Inclusion and exclusion criteria
Entry criteria: having a baby hospitalized in the neonatal intensive care unit; lack of history of neurological and mental illness; No history of allergy and respiratory disorders; No history of drug use (anti-anxiety, anti-stress and anti-depressant); having a baby age between 30 and 37 weeks; Absence of congenital malformation of the baby
Exclusion criteria: infant death; causing postpartum depression; The smell of lavender is unpleasant for the mother; causing allergic reactions such as headache, nausea and other allergic symptoms for the mother
Intervention groups
Mothers of premature babies in the intervention group use a neck pendant containing lavender essential oil, with a dose of two drops in 30 minutes, three times a week, every other day for 4 weeks. No aromatherapy is done for the control group. Both groups complete multidimensional fatigue questionnaires (MFI) and parents' stress assessment in the neonatal intensive care unit (PSS:NICU) at different stages.
Main outcome variables
Fatigue, stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221026056310N1
Registration date:2022-11-21, 1401/08/30
Registration timing:prospective
Last update:2022-11-21, 1401/08/30
Update count:0
Registration date
2022-11-21, 1401/08/30
Registrant information
Name
Azita آزیتا
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8801 6071
Email address
trasib54@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-22, 1401/09/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of inhaling Lavender scent on fatigue and stress of mothers of premature infants admitted to neonatal intensive care unit
Public title
Investigating the effectiveness of lavender scent inhalation on fatigue and stress of mothers of premature babies
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a baby in the neonatal intensive care unit
No history of neurological and mental illness
No history of allergies and respiratory disorders
No history of drug use (anti-anxiety, anti-stress and anti-depressant)
willingness to participate in the study
Avoid drinking caffeinated beverages one hour before the intervention (due to the close relationship between insomnia and fatigue).
The age of the baby is between 30 and 37 weeks
Absence of congenital malformation of the baby
Exclusion criteria:
Death of a baby
Creating postpartum depression
The smell of lavender is unpleasant for the mother
Causing allergic reactions such as headache, nausea and other allergic symptoms for the mother
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
First, we put the studied hospitals (Medical Center, Bahrami, Shariati, Valiasr, Yas, Baharlo and Arash hospitals) into two intervention and control groups through lottery. Then, in the mentioned hospitals, based on the entry criteria and exit criteria, we consider a number of mothers of premature babies as the statistical population. In the next step, we assign a unique number to each of the mothers and put the numbers in a bag. Based on the lottery, we draw numbers until we reach the desired sample size in each of the intervention and control groups.
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
Working Group/Committee Ethics in Research Faculty of Nursing and Midwifery and Faculty of Rehabilit
Street address
End of Kargar North, in front of Masjid al-Nabi, Koi Complex for Girls of Medical Sciences, Tehran
City
Tehran
Province
Tehran
Postal code
1439957181
Approval date
2022-09-27, 1401/07/05
Ethics committee reference number
IR.TUMS.FNM.REC.1401.078
Health conditions studied
1
Description of health condition studied
Stress and fatigue of mothers of premature babies hospitalized in neonatal intensive care unit
ICD-10 code
F54
ICD-10 code description
Psychological and behavioral factors associated with disorders or diseases classified elsewhere
Primary outcomes
1
Description
Fatigue score in Multidimensional Fatigue Measurement Questionnaire
Timepoint
(before the start of the intervention) and 14 and 28 days after the start of the intervention
Method of measurement
Multidimensional fatigue measurement questionnaire. The Multidimensional Fatigue Measurement Questionnaire is a 20-item self-report tool that provides a deeper and more accurate understanding of a person's fatigue by evaluating 5 dimensions. The multidimensional fatigue measurement questionnaire has 5 areas: general fatigue (4 items), physical fatigue (4 items), mental fatigue (4 items), activity-related fatigue (4 items) and decreased motivation (4 items). In the fatigue questionnaire, people are measured both in the physical dimension and in the mental dimension. The answer range for each question was a 5-point Likert scale ranging from "yes, completely true" to "no, completely false".
2
Description
Stress score in parental stress questionnaire in neonatal special care unit
Timepoint
(before the start of the intervention) and 14 and 28 days after the start of the intervention
Method of measurement
Parental stress questionnaire in neonatal special care unit. The parental stress questionnaire in the neonatal intensive care unit is a 34-item self-report tool that is used to measure parents' perception of stress in the neonatal intensive care unit. In this questionnaire, there are three subscales that include stress related to: 1- the sights and sounds of the neonatal intensive care unit environment (6 items), 2- the appearance and behavior of the baby and the special treatments performed on the baby (17 items). and 3- parents' relationship with the baby and parental roles (11 items). Answers were scored on a 5-point Likert scale with "1" being "no stress" and "5" being "extremely stressful". A higher score in this questionnaire indicates more stress experience.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, lavender essential oil (Lavandula angustifolia) produced by Zardband Yasouj Company - Iran, which is prepared from the flowering branches of the plant and contains 45% linalool, will be used. This substance is inhaled by mothers of premature babies through a neck pendant. This neck pendant is placed at a distance of 20 cm from the nose and inhaled with a dose of two drops for 4 weeks every other day for 30 minutes.
Category
Other
2
Description
Control group: No aromatherapy is performed in the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Batol Pouraboli
Street address
Dr. Gharib Street, at the end of Keshavarz Boulevard, Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Fax
+98 21 6119 0000
Email
Imamhospital@tums.ac.ir
Web page address
https://ikhc.tums.ac.ir/
2
Recruitment center
Name of recruitment center
Arash Women's General Hospital
Full name of responsible person
Batol Pouraboli
Street address
Corner of 162 Alley (Shahid Abdul Majid), Shahid Bagh Darnia St. (Rashid Shamali), after Shahid Bagheri highway, Resalat highway
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
+98 21 7788 3196
Email
hosp_arash@tums.ac.ir
Web page address
https://arash.tums.ac.ir/
3
Recruitment center
Name of recruitment center
Shariati Hospital, Tehran
Full name of responsible person
Batol Pouraboli
Street address
North Kargar St., Jalal Al Ahmad Three Roads
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
shariatihosp@tums.ac.ir
Web page address
http://shariati.tums.ac.ir/
4
Recruitment center
Name of recruitment center
Bharlo Hospital
Full name of responsible person
Batol Pouraboli
Street address
Railway Square, Behadari St
City
Tehran
Province
Tehran
Postal code
1339973111
Phone
+98 21 5565 8500
Fax
+98 21 5564 8189
Email
baharloo@sina.tums.ac.ir
Web page address
https://baharloo.tums.ac.ir/
5
Recruitment center
Name of recruitment center
Yas Hospital
Full name of responsible person
Batol Pouraboli
Street address
North Nejat Elahi St, Mirzai Shirazi St, next to Sarvo St
City
Tehran
Province
Tehran
Postal code
1598718311
Phone
+98 21 4216 0000
Fax
+98 21 8894 8217
Email
yashospital@gmail.com
Web page address
https://yashospital.tums.ac.ir/
6
Recruitment center
Name of recruitment center
Bahrami Children's Hospital
Full name of responsible person
Batol Pouraboli
Street address
Damavand St, not reaching Mian Imam Hossein, Shahid Kiaei St (Qasim Abad)
City
Tehran
Province
Tehran
Postal code
4499116417
Phone
+98 21 7301 3000
Fax
+98 21 7755 1584
Email
hosp_bahrami@tums.ac.ir
Web page address
https://bahrami.tums.ac.ir/
7
Recruitment center
Name of recruitment center
Children's Medical Center
Full name of responsible person
Batol Pouraboli
Street address
No. 62, at the end of Keshavarz Blvd, Dr. Mohammad Gharib St, next to Imam Khomeini Hospital (RA)
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6693 0024
Fax
+98 21 6693 0024
Email
cmcpr@tums.ac.ir
Web page address
https://chmc.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotuhi
Street address
Keshavarz Blvd, Qods Corner, Headquarters of Tehran university of medical sciences
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8889 6696
Fax
+98 21 6405 3242
Email
tumspr@tums.ac.ir
Web page address
https://tums.ac.ir/
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
Azita Ghorbani
Position
Master's student in neonatal special care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
North Kargar St, in front of 16th St, Koi complex Tehran university of medical sciences
City
Tehran
Province
Tehran
Postal code
1439957181
Phone
+98 21 8801 6071
Email
Trasib54@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azita Ghorbani
Position
Master's student in neonatal special care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
North Kargar St, in front of 16th St, Koi complex Tehran university of medical sciences
City
Tehran
Province
Tehran
Postal code
1439957181
Phone
+98 21 8801 6071
Email
Trasib54@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azita Ghorbani
Position
Master's student in neonatal special care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
North Kargar St, in front of 16th St, Koi complex, Tehran university of medical sciences
City
Tehran
Province
Tehran
Postal code
1439957181
Phone
+98 21 8801 6071
Email
Trasib54@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
3 months after printing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers are allowed to use the results of the data for use in future articles.
From where data/document is obtainable
Azita Ghorbani, contact number 0098 9180857399,
E-mail address: Trasib54@gmail.com, North Kargar St., in front of 16th St., Tehran University of Medical Sciences Girls' Dormitory, Postal code 1439957181
What processes are involved for a request to access data/document
The applicant can send his request by e-mail. If you wish, the data will be sent to them after 3 days.