Determining the effect of aromatherapy with rose essential oil on postpartum grief in nulliparous women
Design
A randomized clinical trial with a control group(placebo), with parallel groups,without blinding,
Settings and conduct
Sampling is done in the Department of Obstetrics and Gynecology of Umm al-Binin Hospital in Mashhad. The researcher will attend at the hospital and based on the selection criteria, eligible mothers were selected as available.Through questions from the research unit and her file, Stein's postpartum blues questionnaire and Paswald's olfactory scale (for entry criteria of not having Impaired sense of smell) and Rosenberg's self-esteem scale (for homogenization of confounding variable) and Rotten's visual fatigue intensity scale in 12 to 24 hours after delivery through questions from The research unit is completed. Subjects are randomly divided into two intervention and placebo group, In both, within 12 to 24 hours after delivery, it is recommended for two weeks after delivery, twice a day(one time when waking up and one time before going to bed at night) and each time 7 drops of rose essential oil or placebo(sweet almond oil) ) on the mask and inhale it with deep breathing for 20 minutes each time. Stein's postpartum blues questionnaire on the fourth and fourteenth day after Delivery is completed in person and on the 10th day after delivery by phone.
Participants/Inclusion and exclusion criteria
Inclusion criteria:obtaining informed consent،age range 18-42, postpartum blues score greater than8,having a normal delivery.Exclusion criteria:Allergic to rose essential oil or sweet almond oil
Intervention groups
Intervention group: put 7 drops of rose essential oil on the mask twice a day for 14 days and inhale each time for 20 minutes with deep breathing.
Placebo group: sweet almond oil will be used similar with intervention.
Main outcome variables
Postpartum blues score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220606055089N1
Registration date:2022-08-08, 1401/05/17
Registration timing:registered_while_recruiting
Last update:2022-08-08, 1401/05/17
Update count:0
Registration date
2022-08-08, 1401/05/17
Registrant information
Name
Roya Tabasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4423 2347
Email address
tabasir992@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-16, 1401/04/25
Expected recruitment end date
2022-10-12, 1401/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with Damask rose essential oil on postpartum blues in nulliparous women
Public title
The effect of aromatherapy with Damask rose essential oil on postpartum blues
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent to participate in the study
Being at least literate
Having Iranian nationality
Being a resident of Mashhad
Age ranged 42-18 years
Having a postpartum blues disorder (from the Stein postpartum blues questionnaire) scores higher than 8
Being primiparous
Having a normal vaginal delivery
Not having high-risk pregnancy
Having a singleton pregnancy
Not having hard and prolonged labor
Not having disturbance in the sense of smell
Not having major medical conditions
Not having experience of tragic events in the last six months
Not having known history of mental illness
Not using tobacco, alcohol or drugs
Exclusion criteria:
Allergic to rosemary essential oil or sweet almond oil
The mother or baby being hospitalized
Age
From 18 years old to 42 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
The random assignment of the sample in two groups is determined by the permutation block method by the sealedenvelope site, with the explanation that each block has 4 members and the shape of the blocks, for example, can be as follows: [ABAB], [BBAA], [BABA] Codes A and B are assigned randomly to the intervention group and the placebo group. The aforementioned site randomly selects 16 blocks out of all four possible blocks so that all patients can be included in the study.
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
Ethics Committee of Mashhad University of Medical Sciences
Street address
Qureshi Building University Street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9173595199
Approval date
2022-07-06, 1401/04/15
Ethics committee reference number
IR.MUMS.NURSE.REC.1401.028
Health conditions studied
1
Description of health condition studied
Postpartum Blues
ICD-10 code
O90.6
ICD-10 code description
Postpartum mood disturbance
Primary outcomes
1
Description
Postpartum blues score from Stein's postpartum grief questionnaire
Timepoint
before the start of the intervention and 4،10, 14 days after the start of aromatherapy
Method of measurement
Stein postpartum blues questionnaire
Secondary outcomes
1
Description
Fatigue level
Timepoint
before the intervention and 4, 10 and 14 days after the start of aromatherapy
Method of measurement
visual measure of Roten fatigue intensity
Intervention groups
1
Description
Intervention group: In the intervention group, during the first 12 to 24 hours after delivery, seven drops of Barij rose essential oil, a standardized essential oil based on at least 0.2 mg of nerol per milliliter, prepared by extraction with an organic solvent, will be dripped on a three-layer white disposable surgical mask with drops, and they will breath deeply for twenty minutes each time. It is recommended to repeat this process every morning when you wake up and at night when you go to sleep for 14 days after giving birth.
Category
Treatment - Drugs
2
Description
Control group: Sweet almond oil placebo During the first 12 to 24 hours after delivery, seven drops of sweet almond oil will be dripped on a three-layer white disposable surgical mask with a dropper, and they will breathe deeply for twenty minutes each time. It is recommended to repeat this process every morning when you wake up and at night when you go to sleep for 14 days after giving birth.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Umm al-Binin Hospital
Full name of responsible person
Dr. Farideh Akhlaghi
Street address
Ayatolah Bahjat St
City
Mashhad
Province
Razavi Khorasan
Postal code
9144734756
Phone
+98 51 3223 1061
Email
royatbc@gmail.com
Web page address
http://www.mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayyur Mobarahan
Street address
Qureshi Building University St., Vice Chancellor for Research and Technology, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
917751365
Phone
+98 51 3882 5523
Email
ghayourM@mums.ac.ir
Grant name
Grant code / Reference number
4002143
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Roya Tabasi
Position
Master's degree student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
midwifery
Street address
School of Nursing and Midwifery, Crossroads Doctora, Ibne Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
tabasiR992@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Maryam Moradi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery, Crossroads Doctora, Ibne Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
0098 51 38591511-3
Email
moradim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Roya Tabasi
Position
Master's degree student of midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
School of Nursing and Midwifery, Crossroads Doctora, Ibne Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
tabasiR992@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is 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
Not applicable
Title and more details about the data/document
Publication of research results in the form of scientific article printining
When the data will become available and for how long
data will become available after publication of the article
To whom data/document is available
The general public and all researchers
Under which criteria data/document could be used
To inform the public about the effect of aromatherapy with rose essential oil on postpartum blues in primiparous women and scientific use based on the article.
From where data/document is obtainable
Dr. Maryam Moradi, Assistant Professor, Mashhad School of Midwifery Nursing, e-mail: moradim@mums.ac.ir
What processes are involved for a request to access data/document
Request to access data through email and request will be assessed by the research team.