because relaxation is an essential interventions for removal stress, anxiety and depression based on psychoneuroimmunology science and haven't any research about effect of Benson relaxation on stress, anxiety and depression in pregnant women until now, we want to assess this very Inexpensive, effective,efficient and convenient method on stress, anxiety and depression in pregnant women. this research is randomized clinical trial with case and control groups that assess effect of Benson relaxation on foregoing cases,
participants division is randomized using Table of random numbers. research area is health centers of varamin-pishva.in this research pregnant women that are in third trimester are assessed. in two groups all women that have mild stress, anxiety and depression are assessed. in case group in one month 2 times daily, morning & evening became relaxed and in next month & 2 month later is assessed with using of DASS-21 questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201306069463N14
Registration date:2017-08-16, 1396/05/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-08-16, 1396/05/25
Registrant information
Name
Zahra Behboodi Moghadam
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
behboodi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Benson Relaxation method on stress, anxiety and depression in pregnant women
Public title
Effect of Benson Relaxation method on stress, anxiety and depression in pregnant women
Purpose
Supportive
Inclusion/Exclusion criteria
INCLUSION criteria:nuli parity, without history of abortion or infertility, women in third trimester of pregnancy, be literacy, ability to use CD of Benson Relaxation and didn't pass similar relaxation course, not using alcohol & opioid, without history of chronic disease, without history of psychologic disorders,without history of using psychoactive drugs,
EXCLUSION criteria: without tendency of participants to follow research, pregnancy disorders (e.g: placenta abruption, abnormal presentation and so on), decrease of fetal movement that needs intervention
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran 16 Azar Street
City
Tehran
Postal code
Approval date
2017-04-15, 1396/01/26
Ethics committee reference number
IR.TUMS.FNM.REC.1396.2078
Health conditions studied
1
Description of health condition studied
stress
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction
2
Description of health condition studied
anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
3
Description of health condition studied
depression
ICD-10 code
F32.0
ICD-10 code description
Mild depressive episode
Primary outcomes
1
Description
depression
Timepoint
befor & after intervention
Method of measurement
DASS-21 questionnaire
2
Description
stress
Timepoint
befor & after intervention
Method of measurement
DASS-21 questionnaire
3
Description
anxiety
Timepoint
befor & after intervention
Method of measurement
DASS-21 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
CD of Benson relaxation is gave to case group. after training, case group in one month 2 times daily, morning & evening became relaxed and is assessed in next month & 2 month later with using of DASS-21 questionnaire and compared with control group.
Category
Behavior
2
Description
CD of Benson relaxation isn't gave to control group. anxiety, stress and depression is assessed in first visit and in next month & 2 month later with using of DASS-21 questionnaire and compared with case group.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Varamin Health Care Centers
Full name of responsible person
Azade Zenouzi
Street address
Varamin, Bahonar Bulvar
City
Varamin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ziba Taghizade
Street address
Tehran, keshavarz, 16 Azar Street
City
Tehran
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
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
Tehran University Of Medical Science,Faculty of Nursing & Midvifery
Full name of responsible person
Azade Zenouzi
Position
MS of Midvifery
Other areas of specialty/work
Street address
Varamin Bahonar Bulvar
City
Varamin
Postal code
Phone
+98 21 3624 8122
Fax
Email
zenozi.az@gmail.com
Web page address
www.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University Of Medical Science,Faculty of Nursing & Midvifery
Full name of responsible person
Zahra Behboodi Moghadam
Position
Reproductive Health phd
Other areas of specialty/work
Street address
Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
bahar_behboodi@yahoo.com
Web page address
www.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University Of Medical Science,Faculty of Nursing & Midvifery
Full name of responsible person
Azade Zenouzi
Position
MS of Midvifery
Other areas of specialty/work
Street address
Varamin
City
Varamin
Postal code
Phone
+98 21 3624 8122
Fax
Email
zenozi.az@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)