The study is a randomized controlled trial to comparison of the effect of cognitive counseling versus routine care on adaptation of women with unplanned pregnancy. Nine health centers from three low, moderate and high social and economic areas in Zanjan will be selected randomly. Then, among the mothers who have inclusion criteria, consists of unplanned pregnancy and gestational age less than 14 weeks, 54 women will be selected with convenience sampling method, and will be divided into intervention (27 person) and control (27 person) groups with blocked randomization method (block 4-person) . In intervention group, nine women in each group will participate in counseling sessions. Counselling with the intervention group in 8 sessions of about 60 to 90 minutes based on their needs will be done by the researcher. The control group will receive only routine care. Counseling sessions will be done at the health center where sampling has taken place. Adaptation with pregnancy, maternal-fetal attachment and quality of life will be measured by the data collection tool. The tool includes prenatal self-evaluation questionnaire, Cranley’s maternal-fetal attachment questionnaire and the quality of life questionnaire; which will be completed at baseline, immediately after the intervention, and one month after the last session in both intervention and control groups by self-report method.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042228352N5
Registration date:2017-10-01, 1396/07/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-10-01, 1396/07/09
Registrant information
Name
Roghieh Kharaghani
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8144
Email address
r.kharaghani@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Zanjan University of Medical Sciences
Expected recruitment start date
2017-08-12, 1396/05/21
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of cognitive counseling versus routine care on adaptation of women with unplanned pregnancy
Public title
Comparison of the effect of cognitive counseling versus routine care on adaptation of women with unplanned pregnancy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Should have unplanned pregnancy; To be interested to participate in the study; Lacking the history of obstetric complications, psychological disease and medicine use; Gestational age less than 14 weeks; Lack of known psychological disease; Be married (and live with her husbands); Pregnant woman has an alive mother; Lack of narcotic substances abuse in women or her husbands; At least have secondary school education.
Exclusion criteria: The unwillingness to continue the cooperation in the study; Non-participation in two or more than two sessions of counseling; Incidence of any pregnancy complications such as abortion and fetal death;The occurrence of any stressor event or accident during the study; The incidence of any clinical conditions in patients, which cause to impossibility of the intervention; Incompleteness of the questionnaires so that more than 20% of questions are unanswered.
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Block randomization method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
Ethics committee of Zanjan University of Medical Sciences, First floor, North side Azadi, Zanjan
City
Zanjan
Postal code
4515613113
Approval date
2017-07-18, 1396/04/27
Ethics committee reference number
ZUMS.REC.1396-66
Health conditions studied
1
Description of health condition studied
Unplanned pregnancy
ICD-10 code
Z64.0
ICD-10 code description
Problems related to unwanted pregnancy
Primary outcomes
1
Description
Adaptation of unplanned pregnancy
Timepoint
At baseline, immediately after the intervention and one month after the Last counseling session
Method of measurement
Prenatal self-evaluation questioner
Secondary outcomes
1
Description
Quality of life
Timepoint
At baseline, immediately after the intervention and one month after the Last counseling session
Method of measurement
World Health Organization quality of lifes questioner-26
2
Description
Maternal-fetal attachment
Timepoint
At baseline, immediately after the intervention and one month after the Last counseling session
Method of measurement
Cranley’s maternal-fetal attachment scale
Intervention groups
1
Description
The intervention group will be 27 people that nine people in each group will participate in counseling sessions.Consultations with the intervention group will be done by the researcher in 8 sessions in each week and a 60 to 90 minute session will be held based on their needs. In order to increase women’s willing to participate in counseling, corroborant and strengthening messages will be sent by researcher’s mobile phone at the end of each session.
Category
Other
2
Description
Control group: in this group no counseling will be received and only the routine pregnancy care will be done.At the end of the study, educational pamphlets and packages, which gave to the intervention group, will give to the control group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Center No. 6
Full name of responsible person
Azadeh Arasteh
Street address
Shaheed Hossein Hasani Street, Islamabad
City
zanjan
2
Recruitment center
Name of recruitment center
Health Center No. 13
Full name of responsible person
Azadeh Arasteh
Street address
Next to the Imam Khomeini Relief Committee, Khayyam Street
City
zanjan
3
Recruitment center
Name of recruitment center
Health Center No. 15
Full name of responsible person
Azadeh Arasteh
Street address
One Yasmine Street, Farhang Blvd
City
Zanjan
4
Recruitment center
Name of recruitment center
Health Center No. 2
Full name of responsible person
Azadeh Arasteh
Street address
Montazery Street, Airport Street
City
Zanjan
5
Recruitment center
Name of recruitment center
Health Center No. 5
Full name of responsible person
Azadeh Arasteh
Street address
Taleghani Street
City
Zanjan
6
Recruitment center
Name of recruitment center
Health Center No. 8
Full name of responsible person
Azadeh Arasteh
Street address
Next to Amjadiyeh, 17th Shahrivar Street
City
Zanjan
7
Recruitment center
Name of recruitment center
Health Center No. 3
Full name of responsible person
Azadeh Arasteh
Street address
The beginning of northern sadi, Sadi Crossing
City
Zanjan
8
Recruitment center
Name of recruitment center
Health Center No. 7
Full name of responsible person
Azadeh Arasteh
Street address
West Ninth Street, Jomhory Islami Blvd
City
Zanjan
9
Recruitment center
Name of recruitment center
Health Center No. 14
Full name of responsible person
Azadeh Arasteh
Street address
Fourth Street, Karmandan Blvd
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Zanjan University of Medical Sciences
Full name of responsible person
Alireza Shoghli
Street address
North side Azadi Boulevard
City
Zanjan
Grant name
پايان نامه
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Zanjan 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
Zanjan University of Medical Science
Full name of responsible person
Azadeh Arasteh
Position
Msc student of midwifery counselling
Other areas of specialty/work
Street address
No.61, Ghaem 6, Ghaem Street
City
Ferdows
Postal code
9771973197
Phone
+98 56 3272 4212
Fax
Email
Azadearaste@yahoo.com
Web page address
www.zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Roghieh Kharaghani
Position
Ph.D of Reproductive Health
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Karmandan town
City
Zanjan
Postal code
4515786339
Phone
+98 24 3315 6344
Fax
+98 42 49553
Email
r.kharaghani@zums.ac.ir
Web page address
www.zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Roghieh Kharaghani
Position
Ph.D of Reproductive Health
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Karmandan town
City
Zanjan
Postal code
4515786339
Phone
+98 24 3315 6344
Fax
+98 42 49553
Email
r.kharaghani@zums.ac.ir
Web page address
www.zums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)