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The effect of counselling on anxiety,acute stress reactions and posttraumatic stress reactions of women with miscarriage

Protocol summary

Summary
Main objective of the study is The impact of counselling on anxiety,acute stress reactions and posttraumatic stress reactions of women suffer from miscarriage. This study is a randomized control trial. Inclusion criteria include nulligravides with definite symptoms of miscarriage, literate, no addiction, no history of using antidepressant and relaxant agents, no stressful events since 6 month ago, no known mental disease and refractory chronic diseases, no history of infertility. Exclution criterias are: taking antidepressant and relaxant agents during 2 first weeks of intervention;accurance of stressful events during study.100 patients using randomized form are divided into intervention and control groups. Intervention includes 3 counselling sessions in 3 weeks. Every session lasts 40-60 minutes. control group will receive routines care. Just after third session, 1,2 and 3 months later,questionnaires will filled again by patients. In this study we use 4 questionnaires: demographic, Hospital anxiety and depression scale,Stanford acute stress reaction and Impact of events scale.At the end, anxiety, acute stress reactions and posttraumatic stress reactions will compared between control group and intensive group.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201401042248N13
Registration date: 2014-03-04, 1392/12/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-03-04, 1392/12/13
Registrant information
Name
Fereshteh Jahdi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00982188773073,00982182471404
Email address
f.jahdi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counselling on anxiety,acute stress reactions and posttraumatic stress reactions of women with miscarriage
Public title
The effect of counselling on anxiety,acute stress reactions and posttraumatic stress reactions of women with miscarriage
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criterias: nulligravides with definite symptoms of miscarriage; literate; no addiction; no history of using antidepressant and relaxant agents; no stressful events since 6 month ago; no known mental disease and refractory chronic diseases; no history of infertility. Exclution criterias:taking antidepressant and relaxant agents during 2 first weeks of intervention;accurance of stressful events during study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
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
Tehran university of medical sciences
Street address
Sixth floor,Central building of university, Next to Ghods street,Keshavarz bulivard,Tehran,Iran
City
Tehran
Postal code
Approval date
2013-11-23, 1392/09/02
Ethics committee reference number
130/1909/د/92

Health conditions studied

1

Description of health condition studied
Miscarriage
ICD-10 code
o03
ICD-10 code description
Pregnancy with abortive outcome(o00-o08)

Primary outcomes

1

Description
Post traumatic stress reactions
Timepoint
Before intervention,after intervention,1 month,2 months and 3 months after
Method of measurement
Impact of events scale

2

Description
Anxiety
Timepoint
Before intervention,after intervention,1 month,2 months and 3 months after
Method of measurement
Hospital anxiety and depression scale

3

Description
Acute stress reactions
Timepoint
Before intervention,after intervention,1 month and 2 months after
Method of measurement
Stanford acute stress reactions questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Interventional group: three individual counseling session for 40-60 min during first 24 hours after miscarriage,1 and 2 weeks later
Category
Behavior

2

Description
Control group: Post abortion routine care
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Akbar Abadi Hospital
Full name of responsible person
Mahnaz Mosayeb Moradi
Street address
Tehran, Molavi crossroads, Bagh Ferdos station
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Fereshteh Jahdi
Street address
School of nursing and midwifery, Nosrat east avenue , Tohid square ,Tehran,Iran
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 sciences, school of midwifery and nursing
Full name of responsible person
Fereshteh Jahdi
Position
Master of Science, Faculty of nursing and midwifery
Other areas of specialty/work
Street address
Nosrat east avenue,Tohid square,Tehran,Iran
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6690 4252
Email
fnm@tums.ac.irf_jahdi@yahoo.com
Web page address
fnmsite@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran university of medical sciences, school of midwifery and nursing
Full name of responsible person
Fereshteh Jahdi
Position
Master of Science, Faculty of nursing and midwifery
Other areas of specialty/work
Street address
Nosrat east avenue,Tohid square,Tehran,Iran
City
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6690 4252
Email
fnm@tums.ac.irf_jahdi@yahoo.com
Web page address
fnmsite@tums.ac.ir

Person responsible for updating data

Contact

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
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