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Comparative investigation between the effect of aromatherapy with Rosa damascena Mill. and Mindfulness-Based Stress Reduction (MBSR) on gestational hypertension in pregnant women

Protocol summary

Study aim
Comparative investigation between the effect of aromatherapy with Rosa damascena Mill. and Mindfulness-Based Stress Reduction (MBSR) on gestational hypertension in pregnant women
Design
The clinical trial has two intervention groups and one control group, with parallel, not blinded, simple randomized , on 75 patients, a computer system with sampling software has been used for randomization.
Settings and conduct
The statistical population includes 75 pregnant women who have referred to Yazd health centers to receive routine pregnancy services, and after taking the mother's blood pressure, the diagnosis of pregnancy blood pressure has been considered for them. Then the selected patients are divided into two intervention groups and one control group using simple random method.
Participants/Inclusion and exclusion criteria
Entry conditions: Iranian race, age 18 to 40 years, literacy, singleton pregnancy, systolic blood pressure more than 14 and diastolic blood pressure more than 9, number of pregnancies 4 and less Conditions for not entering: history of high blood pressure before the current pregnancy or in the first 20 weeks (80/130 or more), suffering from pre-eclampsia and eclampsia in previous pregnancies, taking psychiatric drugs, suffering from anxiety and depression, allergy to rose essential oil or a history of allergies and respiratory diseases
Intervention groups
Intervention group 1: "under aromatherapy treatment" which is treated with 40% Rosa damascena essence by inhalation twice a day for 8 weeks. Intervention group 2: "Treated with mindfulness-based stress reduction counseling" in which 8 sessions of 90 minutes twice a week, mindfulness-based stress reduction counseling are given. Group 3: is the control group that does not receive any intervention.
Main outcome variables
Systolic blood pressure, diastolic blood pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230313057700N1
Registration date: 2023-05-13, 1402/02/23
Registration timing: prospective

Last update: 2023-05-13, 1402/02/23
Update count: 0
Registration date
2023-05-13, 1402/02/23
Registrant information
Name
Mohadese Daneshpajooh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3625 9747
Email address
mmmohadese2016@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2023-09-22, 1402/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative investigation between the effect of aromatherapy with Rosa damascena Mill. and Mindfulness-Based Stress Reduction (MBSR) on gestational hypertension in pregnant women
Public title
Comparative investigation between the effect of aromatherapy with Rosa damascena Mill. and Mindfulness-Based Stress Reduction (MBSR) on gestational hypertension in pregnant women
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian race Age 18 to 40 Being literate Singleton pregnancy The first visit before the 16th week of pregnancy Systolic blood pressure more than 14 and diastolic blood pressure more than 9 The number of pregnancies is 4 or less Healthy sense of smell
Exclusion criteria:
History of high blood pressure before the current pregnancy or in the first 20 weeks (80/130 or more) Suffering from pre-eclampsia and eclampsia in previous pregnancies Taking psychiatric drugs Suffering from anxiety and depression Allergy to Rosa damascena essential oil or history of allergies and respiratory diseases
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization according to the numbered list by the computer system, they are divided into two intervention groups and one control 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 Kerman University of Medical Sciences
Street address
Campus of University of Medical Sciences, first axis of the Haft Bagh Alavi, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-02-28, 1401/12/09
Ethics committee reference number
IR.KMU.REC.1401.541

Health conditions studied

1

Description of health condition studied
Gestational hypertension
ICD-10 code
O13
ICD-10 code description
Gestational [pregnancy-induced] hypertension without significant proteinuria

Primary outcomes

1

Description
Systolic blood pressure
Timepoint
At the beginning of the intervention - twice a week during the intervention - immediately after the end of the intervention
Method of measurement
Mercury sphygmomanometer model ALPK2 made in Japan

2

Description
Diastolic blood pressure
Timepoint
At the beginning of the intervention - twice a week during the intervention - immediately after the end of the intervention
Method of measurement
Mercury sphygmomanometer model ALPK2 made in Japan

Secondary outcomes

1

Description
Anxiety
Timepoint
Before the start of the intervention - immediately after the end of the intervention
Method of measurement
Questionnaire DASS-21

2

Description
depression
Timepoint
Before the start of the intervention - immediately after the end of the intervention
Method of measurement
Questionnaire 21-DASS

3

Description
Stress
Timepoint
Before the start of the intervention - immediately after the end of the intervention
Method of measurement
Questionnaire 21-DASS

Intervention groups

1

Description
Intervention group: First- the group treated with Rosa damascena aromatherapy - which is treated with 40% Rosa damascena essential oil from Barich Essential Oil Company, inhaled twice a day for 8 weeks.
Category
N/A

2

Description
Intervention group: Second - undergoing treatment with mindfulness-based stress reduction counseling -In 8 sessions of 90 minutes face-to-face and group sessions twice a week, mindfulness-based stress reduction counseling is given.
Category
N/A

3

Description
Control group: It does not receive any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd City Health Center
Full name of responsible person
Seyyed Ali Akbar Mousavi Nadushan
Street address
Kashani Street next to Bahman Hospital
City
Yazd
Province
Yazd
Postal code
8913783343
Phone
+98 35 3624 8021
Fax
+98 35 3628 7198
Email
info@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mr. Dr. Abbas Pardakhti
Street address
Campus of University of Medical Sciences, first axis of the Haft Bagh Alavi, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3231 0057
Email
mmmohadase2016@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
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Campus of University of Medical Sciences, first axis of the Haft Bagh Alavi, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3231 0057
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
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Campus of University of Medical Sciences, first axis of the Haft Bagh Alavi, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3231 0057
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
Mohadese Sadat Daneshpajooh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Campus of University of Medical Sciences, first axis of the Haft Bagh Alavi, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3231 0057
Email
mmmohadese2016@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 results are published
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 condition of sending the application is to have a university affiliation.
From where data/document is obtainable
Email to the corresponding author, Masoumeh Ghazanfarpour, Address: Midwifery Research Center, Razi School of Midwifery Nursing, Kerman University of Medical Sciences, Iran. Email: masoumeh.ghazanfarpour@yahoo.com Contact number: 00989136330656
What processes are involved for a request to access data/document
The email requesting data to Mrs. Masoumeh Ghazanfarpour, the responsible author, will be answered after two weeks after going through the administrative process and confirming the identity of the author of the email.
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