Protocol summary

Summary
The main purpose:Effects of counselling on progressive muscle relaxation on anxiety among primigravida women refered to health care centers in Hamadan, 2015 Secondary objectives 1- Comparison of anxiety (explicit and implicit) before and after the intervention in the experimental group 2-Compare anxiety (explicit and implicit) in both experimental and control groups before the intervention, progressive muscle relaxation 3-Compare anxiety (explicit and implicit) in both experimental and control groups after the intervention of progressive muscle relaxation Practical purposes: the results of this study can provide counseling program of muscle relaxation to reduce anxiety in pregnant women.This study is a semi experimental with two groups (experimental and control) with pre-test and post-test.Eligible women were referred to health centers in Hamedan city who experience their first pregnancy consecutively enrolled in the study, after obtaining informed consent .They were randomly assigned to intervention and control groups with regard to Allocation concealment.In this research, consulting in the counseling process (GATHER) during the 60-45 minute sessions will be held in two weeks.Both group will completed anxiety questionnaire in weeks 21-22.The control group only will receive routine prenatal care But experimental group in addition to routine pregnancy care will be trained muscle relaxation exercises.The experimental group was asked to do exercises at home from 21-22 weeks with the help of CD and booklets for 10 weeks, twice a day for 20 minutes each time (morning and evening)And complete the visual analog scale form to determine the relaxation.Performance of both groups at weeks 24-23 and 32-31 were evaluated again using the checklist. Inclusion criteria: The age range 18-35 years ؛first pregnancy and wanted pregnancy ؛single fetus and gestational age 22-21weak ؛not having mental disorders, according to a psychiatrist ؛not having gestational diabetes, preeclampsia, bleeding, premature rupture of membran...؛ ability to participate in educational classes؛Minimum ability to Reading and writing؛not having difficulty of hearing and vision؛Not taking antidepressants ؛Having mild, moderate, or high anxiety exclusion criteria:Any problems in pregnancy during the study period (abruption, fetal abnormal situation, cord prolapse, bleeding, diabetes, hypertension, preterm labor and ...) Abnormal fetal heart rate patterns and decreased fetal movements in a way that may require medical intervention؛ unwillingness to continue cooperation؛ major mental and emotional changes (such as death or serious disputes)

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201412066888N6
Registration date: 2015-04-19, 1394/01/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-04-19, 1394/01/30
Registrant information
Name
Fatemeh Shobeiri
Name of organization / entity
Hamadan Universiy of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1827 6051
Email address
shobeiri@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamadan University of Medical Sciences, Department of Research and Technology
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of counselling on progressive muscle relaxation on anxiety among primigravida women refered to health care centers in Hamadan, 2015
Public title
Effects of counselling on progressive muscle relaxation on anxiety among primigravida women refered to health care centers in Hamadan, 2015
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The age range 18-35 years ؛first pregnancy and wanted pregnancy ؛single fetus and gestational age 22-21weak ؛not having mental disorders, according to a psychiatrist ؛not having gestational diabetes, preeclampsia, bleeding, premature rupture of membran...؛ ability to participate in educational classes؛Minimum ability to Reading and writing؛not having difficulty of hearing and vision؛Not taking antidepressants ؛Having mild, moderate, or high anxiety exclusion criteria:Any problems in pregnancy during the study period (abruption, fetal abnormal situation, cord prolapse, bleeding, diabetes, hypertension, preterm labor and ...) Abnormal fetal heart rate patterns and decreased fetal movements in a way that may require medical intervention؛ unwillingness to continue cooperation؛ major mental and emotional changes (such as death or serious disputes)
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: 120
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
Research Ethics Committee of Hamadan University of Medical Sciences
Street address
Fahmiheh Street, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Postal code
65178
Approval date
2015-01-21, 1393/11/01
Ethics committee reference number
5351/9/35/16/پ

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Anxiety that is generalized and persistent but not restricted to, or even strongly predominating in, any particular environmental circumstances (i.e. it is

Primary outcomes

1

Description
Anxiety
Timepoint
weeks 21-22 and 31-32
Method of measurement
Spielberger Anxiety Inventory (STAI)

Secondary outcomes

1

Description
progressive muscle relaxation
Timepoint
week 23-24 and 31 -32
Method of measurement
Checklist

Intervention groups

1

Description
doing exercises at home from 21-22 weeks with the for 10 weeks, twice a day for 20 minutes each time (morning and evening)
Category
Other

2

Description
The control group will receive regular prenatal care
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Healthcare center Samii 9
Full name of responsible person
masoome taravati
Street address
Madani settlements
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamadan University of Medical Sciences, Department of Research and Technology
Full name of responsible person
fateme asgari
Street address
Fahmiheh Street, Hamadan University of Medical Sciences, Department of Research and Technology
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan University of Medical Sciences, Department of Research and Technology
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
Hamadan University of Medical sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Maternal and Child Health
Other areas of specialty/work
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences
City
Hamadan
Postal code
65178/518
Phone
+98 81 3827 6051
Fax
Email
shobeiri@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Maternal and Child Health
Other areas of specialty/work
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences
City
Hamadan
Postal code
65178/518
Phone
+98 81 3827 6051
Fax
Email
shobeiri@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical sciences
Full name of responsible person
Fatemeh Shobeiri
Position
Ph.D. in Maternal and Child Health
Other areas of specialty/work
Street address
No. 307, Fahmideh Street, Hamadan University of Medical sciences
City
Hamadan
Postal code
65178/518
Phone
+98 818276051
Fax
Email
shobeiri@umsha.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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