Comparison of effect of crisis counseling on anxiety, Decision-Making Style and Strategies in women with unplanned pregnancy in intervention (receive crisis counseling) with control (do not receive crisis counseling) groups
This is an experimental study with the aim of determining the Impact of crisis counseling on anxiety, decision-making style and strategies of women with unplanned pregnancy. Study setting was family physician centers and obstetricians and midwifery offices of the city of Qaemshahr, North of Iran. The statistical population includes 15-49 year-old women with unplanned pregnancy referred to these centers. The sample size is 70 women (35 women in each group). Blinding is not possible. Random allocation to two groups will be done by using Random Number Generator software. Two series in 35 random number will be taken. Women who come to these centers for a pregnancy test and do not have a planned pregnancy, also, women who refer to the centers for asking pregnancy test and have positive pregnancy tests during the past four weeks will be invited to participate in the project. Women, who did not have a plan for childbearing, requested Pregnancy test or had a positive pregnancy test within 4 weeks ago were recruited. Inclusion criteria was reproductive age; have at least one child; Iranian; married; ability to communicate; having general health and positive βhcg.
After receiving written consent, Spielberger's anxiety inventory and style and decision-making strategies of women in the unplanned pregnancy questionnaires will be complete by the participant. If the level of anxiety are high and women with an inappropriate decision style, the phone number will be obtained. Participants will be randomly allocated to one of the two groups based on sequential referring to the centers. In the intervention group, the first session will be held as soon as possible within 4 weeks of the pregnancy confirmation. A total of 4 individual 120-150 minutes counseling sessions are provided. The first 3 sessions will be held at intervals of 3-4 days and the last session will be held one month after the last session. The control group will not receive crisis counseling. Then, two groups' anxiety and style and decision-making strategies in unplanned pregnancy will be compared.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2017100231117N5
Registration date:2017-11-11, 1396/08/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-11, 1396/08/20
Registrant information
Name
Soghra Khani
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 8918
Email address
s.khani@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
VIce-chancellor for research, Mazandaran University of Medical Sciences
Expected recruitment start date
2017-11-01, 1396/08/10
Expected recruitment end date
2018-04-30, 1397/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of crisis counseling on anxiety, Decision-Making Style and Strategies in women with unplanned pregnancy in intervention (receive crisis counseling) with control (do not receive crisis counseling) groups
Public title
Effect of crisis counseling on anxiety, Decision-Making Style and Strategies in Women with unplanned pregnancy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Reproductive age; have at least one child; Iranian; married and currently living with her legal spouse; ability to communicate; having general health (lack of diseases including diabetes, high blood pressure and any known chronic disease, such as cardiovascular, kidney and liver diseases); have a positive Pregnancy test (βhcg).
Exclusion criteria: Appearing of high risk pregnancy symptoms such as bleeding, leaking of liquid through the vagina, existing of suicidal thoughts; severe and major psychiatric disorders; Having a psychosis; Participation in other psychiatric treatment protocols in the last 6 months; Unwilling to participate in the study.
Age
From 15 years old to 49 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)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Random table numbers will be used for random allocating of two groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Mazandaran University of Medical Sciences
Street address
vice chancellor for research of Mazandaran University of Medical Sciences, Moalem Square.
City
Sari
Postal code
Approval date
2017-06-10, 1396/03/20
Ethics committee reference number
IR.MAZUMS.REC.95. 3181
Health conditions studied
1
Description of health condition studied
unwanted pregnancy
ICD-10 code
F64.0
ICD-10 code description
Problems related to unwanted pregnancy
Primary outcomes
1
Description
Anxiety
Timepoint
before intervention,4 week after intervention
Method of measurement
wendenburg pregnancy related anxiety questionnaire; Spielberger Anxiety; GHQ-28;
Secondary outcomes
1
Description
decision-making style and strategies about unplanned pregnancy
Timepoint
before and one month after intervention
Method of measurement
decision-making style and strategies of women with unplanned pregnancy questionnaire
Intervention groups
1
Description
Intervention group: The first session will conduct as soon as possible within a maximum of 4 weeks after the pregnancy test, and a total of 4 120-120 minutes solitary confinement sessions will done according to the Robert's seven-step model, 3 first sessions with a 3-4 day interval and the last session (follow up) will held one month later.
Category
Behavior
2
Description
Control group: This group will not receive the intervention (crisis counseling).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
The centers of the urban family physician and obstetricians and midwifery offices.
Full name of responsible person
Dr Mohammad Geran
Street address
City
Qaemshahr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mazandaran University of Medical Sciences
Full name of responsible person
Dr M. Saeidi
Street address
vice chansellor for research of Mazandaran University of Medical Sciences, Moalem squre
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Mazandaran 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
Mazandaran University of Medical Sciences, Sexual and Reproductive Health Research Center
Full name of responsible person
Dr Soghra Khani
Position
PhD, Moderator (owner) of project
Other areas of specialty/work
Street address
sexual and reproductive healthresearch center, Vesal street, Amir Mazandarani Boulevard
City
Sari
Postal code
Phone
+98 11 3335 8918
Fax
Email
s.khani@mazums.ac.ir, khanisog343@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr soghra Khani
Position
Modarator (owner) of [project/ PhD]
Other areas of specialty/work
Street address
sexual and reproductive healthresearch center, Vesal street, Amir Mazandarani Boulevard
City
Sari
Postal code
Phone
+98 11 3335 8918
Fax
Email
s.khani@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Soghra Khani
Position
PhD/moderator (owner) of project
Other areas of specialty/work
Street address
sexual and reproductive healthresearch center, Vesal street, Amir Mazandarani Boulevard
City
Sari
Postal code
Phone
+98 11 3335 8918
Fax
Email
s.khani@mazums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)