The effect of Inhalation of Melissa officinalis (lemon balm) essential oil on fatigue and sleep quality of mothers of premature infants in the neonatal intensive care unit
This clinical trial study will be conducted to evaluate the effect of inhalation of Melissa officinalis essential oil on fatigue and sleep quality of mothers with premature infants in the neonatal intensive care unit. From mothers with premature infants from 28 to 32 weeks admitted in the Ommolbanin and Imam Reza Hospitals of Mashhad as research community will be invited. The sample size is 25 people in each group who are divided randomly With a draw of packets number one to two into test and control groups. Inclusion criteria are mother's presence within 48 hours after delivery in the department; fetal age of 28-32 weeks; no physical and mental illness; lack of olfactory disorder; no addiction mother to all drugs and psychosis; mothers do not use sedative medications, relaxation and sleep medicine and Sleep disturbances (Pittsburgh Sleep Quality Index 5 or more) and the exclusion criteria are mother's unwillingness in trial for any reason; have an allergic history of herbal medicines; depression; Infant death. This intervention involves inhaled mask dipped in 5 to 7 drops of Melissa officinalis essential oil 1.5% for 20-30 minutes twice daily for two weeks. The main variables of fatigue and maternal sleep quality are evaluated by two Visual Scale of Fatigue Measurement and Pittsburgh Sleep Quality Scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012532190N1
Registration date:2017-11-19, 1396/08/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
Masoume Sinaei
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
sinaeim2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2017-07-06, 1396/04/15
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Inhalation of Melissa officinalis (lemon balm) essential oil on fatigue and sleep quality of mothers of premature infants in the neonatal intensive care unit
Public title
The effect of Inhalation of Melissa officinalis (lemon balm) essential oil on fatigue and sleep quality of mothers of premature infants in the neonatal intensive care unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Mother's informed consent to participate in the intervention; Mother's presence within 48 hours after delivery in the department; Fetal age of 28-32 weeks; No physical and mental illness; Lack of olfactory disorder; no addiction to all drugs and psychosis; Mothers do not use sedative medications, Relaxation and sleep medicine; Sleep disturbances (Pittsburgh Sleep Quality Index 5 or more).
Exclusion criteria: Mother's unwillingness in the trial for any reason; Have an allergic history of herbal medicines; Depression (Depression Scale of Edinburgh 13 or more); Infant death.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
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
Mashhad University of Medical Sciences
Street address
Qaryashi Building, Central Organization of the University, Daneshgah Street
City
Mashhad
Postal code
13944-91388
Approval date
2017-07-02, 1396/04/11
Ethics committee reference number
IR.MUMS.REC.1396.99
Health conditions studied
1
Description of health condition studied
sleep
ICD-10 code
G47
ICD-10 code description
Sleep disorders
2
Description of health condition studied
fatigue
ICD-10 code
R53
ICD-10 code description
Malaise and fatigue
Primary outcomes
1
Description
fatigue
Timepoint
Before the intervention, one week after the intervention and two weeks after the intervention
Method of measurement
Visual Scale of Fatigue Measurement
2
Description
sleep quality
Timepoint
Before the intervention, one week after the intervention and two weeks after the intervention
Method of measurement
Pittsburgh Sleep Quality Scale
Secondary outcomes
empty
Intervention groups
1
Description
Group 1: Control group: There is no intervention for mothers in this group.
Category
Other
2
Description
Group2: Intervention group: Inhaled mask dipped in 5 to 7 drops of lemon balm essential oil 1.5% for 20-30 minutes twice daily for two weeks.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Masoume Sinaei
Street address
Imam Reza Hospital, Ebne Sina Street
City
Mashhad
2
Recruitment center
Name of recruitment center
Ommol Banin Hospital
Full name of responsible person
Masoume Sinaei
Street address
Ommol Banin Hospital, Ayatullah Behjat Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Qaryashi Building, Central Organization of the University, Daneshgah Street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoume Sinaei
Position
Master's student of Neonatal Care Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Ebnesina Street, Daneshgah Street
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
sinaeim2@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University Of Medical Sciences
Full name of responsible person
Tahere Sadeghi
Position
Ph.D. in Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Ebnesina Street, Daneshgah Street
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
SadeghiT@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Masoume Sinaei
Position
Master's student of Neonatal Care Nursing
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Ebnesina Street, Daneshgah Street
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
sinaeim2@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)