Comparative investigation between the effectiveness of Mindfulness-Based Stress¬ Reduction (MBSR) and aromatherapy with rosa damascena flower during pregnancy on the distresses caused by breastfeeding and mother-infant attachment style in women referring to Pasargad, fars health centers, 2022
A comparative study of the effect of mindfulness-based stress reduction counseling (MBSR) and aromatherapy with jasmine flowers during pregnancy on breastfeeding distress and mother-infant attachment style
Design
A clinical trial with two intervention groups and one control group, with parallel, blinded, simple randomized groups, on 75 patients, rand function of Excel software was used for randomization.
Settings and conduct
The statistical population includes 75 qualified pregnant women who have referred to health centers in Pasargad city to receive routine pregnancy services and are divided into two intervention groups and one control group using a simple random method.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Minimum reading and writing literacy; Iranian nationality; Informed consent to participate in the project; Prime pregnant mothers; 29-33 weeks. Exclusion criteria: Having a history of asthma and allergies; Having an allergy to the rose flower; Having symptoms of mental illness; Mother's addiction to drugs; Having a congenital abnormality based on ultrasounds and screening tests in the first and second trimesters; Taking sedative or anti-anxiety drugs.
Intervention groups
Intervention group 1: is treated with aromatherapy, which is the intervention with 40% rosemary essential oil by inhalation twice a day for 4 weeks. Intervention group 2: is treated with mindfulness-based stress reduction counseling, which is done in 8 sessions of 90 minutes twice a week. Group 3: is the control group that does not receive any intervention.
Main outcome variables
Distress caused by breastfeeding, mother-infant attachment style
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230714058772N1
Registration date:2023-07-31, 1402/05/09
Registration timing:prospective
Last update:2023-07-31, 1402/05/09
Update count:0
Registration date
2023-07-31, 1402/05/09
Registrant information
Name
Masoumeh Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4356 2628
Email address
yashashemi2628@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative investigation between the effectiveness of Mindfulness-Based Stress¬ Reduction (MBSR) and aromatherapy with rosa damascena flower during pregnancy on the distresses caused by breastfeeding and mother-infant attachment style in women referring to Pasargad, fars health centers, 2022
Public title
Comparative investigation between the effectiveness of Mindfulness-Based Stress¬ Reduction (MBSR) and aromatherapy with rosa damascena flower during pregnancy on the distresses caused by breastfeeding and mother-infant attachment style
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum reading and writing literacy
Iranian nationality
Informed consent to participate in the project
Prime pregnant mothers, 29-33 weeks
Exclusion criteria:
Having a history of asthma and allergies
Having an allergy to the rose flower
Having symptoms of mental illness
Mother's addiction to drugs
Having a congenital abnormality based on ultrasounds and screening tests in the first and second trimesters
Taking sedative or anti-anxiety drugs
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done according to the numbered list by a computer system. Therefore, a number will be assigned to each sample, and after choosing the starting point in the table, read the table numbers from right to left and from top to bottom. It will be low. The first 25 selected numbers in the table will be the control group, the second 25 will be the mindfulness intervention group, and the third 25 will be the aromatherapy intervention group.
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 of Kermam University of Medical Sciences
Street address
Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-07-15, 1402/04/24
Ethics committee reference number
IR.KMU.REC.1402.086
Health conditions studied
1
Description of health condition studied
Distress caused by breastfeeding
ICD-10 code
ICD-10 code description
2
Description of health condition studied
mother-infant attachment style
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Distress caused by breastfeeding
Timepoint
before the intervention and immediately after the intervention
Method of measurement
Breastfeeding distress questionnaire
Secondary outcomes
1
Description
Mother-infant attachment
Timepoint
One month after giving birth
Method of measurement
Condon and Corkindle infant attachment questionnaire; Cranley Fetal Attachment Questionnaire
Intervention groups
1
Description
Intervention group: first-The group treated with rosemary aromatherapy, which is treated with 40% rosemary essential oil from Barich Essential Oil Company, by inhalation twice a day for 4 weeks.
Category
N/A
2
Description
Intervention group: 2nd- Undergoing stress reduction counseling based on mindfulness, which is given in 8 face-to-face 90-minute sessions and as a group twice a week.
Category
N/A
3
Description
Control group: does not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Pasargad city
Full name of responsible person
Fatemeh Hosseinpour
Street address
Saadat Shahr, Imam Blvd., facing Imam Jafar Sadiq Hospital
City
Pasargad
Province
Fars
Postal code
7374163196
Phone
+98 71 4356 7777
Email
pasargad@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mr. Dr. Abbas Pashti
Street address
Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
yashashemi2628@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
2
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mr. Dr. Abbas Pashti
Street address
Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
yashashemi2628@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
40
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
Kerman University of Medical Sciences
Full name of responsible person
Masoume Ghazanfarpour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
masoumeh.ghazanfarpour@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Masoume Ghazanfarpour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
0098 31325700
Email
masoumeh.ghazanfarpour@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Masoumeh Hashemi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Kerman, the beginning of Haft Bagh Alavi axis, University of Medical Sciences campus
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
yashashemi2628@gmail.com
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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only part of the information related to the main outcome is shared.
When the data will become available and for how long
Access starts 6 months after the announcement of the results
To whom data/document is available
Academic and scientific institutions
Under which criteria data/document could be used
It is allowed to use in order to expand the science of mindfulness. The conditions for submitting an application are also to have a university affiliation
From where data/document is obtainable
Email to the corresponding author, Masoumeh Ghazanfarpour, address: Midwifery Research Center, Razi Midwifery Nursing School, Kerman University of Medical Sciences, Iran, email: masoumeh.ghazanfarpour@yahoo.com, contact number: 098 34 31325700
What processes are involved for a request to access data/document
The data request email to Ms. Masoumeh Ghazanfarpour, the responsible author, will be answered after two weeks after going through the administrative process and verifying the identity of the email author.