Determining the effect of counseling based on acceptance and commitment on coping self-efficacy of mothers with unplanned pregnancy
Design
The clinical trial has an intervention group and a control group, with parallel groups, randomized by randomized block method in 27 blocks of 4 from the table of random numbers, on 108 people.
Settings and conduct
The research environment will be health care centers in Ardabil city and the research population will include all women with unplanned pregnancy referring to health and treatment centers in Ardabil city. Eligible people will be randomly assigned to one of the intervention and control groups. According to the protocol, the intervention group will participate in 8 counseling sessions and the control group will receive routine care. After the intervention, coping self-efficacy will be measured immediately after the end of the intervention and 2 months after the intervention.
Participants/Inclusion and exclusion criteria
Entry requirements: pregnant (pregnant age less than 18 weeks)
Obtaining a score of less than 3 based on the London Unplanned Pregnancy Assessment Questionnaire
Conditions of non-entry: drug abuse and addiction (file and self-report)
Psychological problems (file and self-report)
Absence of more than two sessions in counseling sessions
Intervention groups
For the intervention group, counseling sessions based on acceptance and commitment will be held in 8 sessions, twice a week in groups of 8 people. The time of each session will be 90 minutes. Routine pregnancy care will be considered for the control group.
Main outcome variables
coping self-efficacy score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151211025477N7
Registration date:2023-08-28, 1402/06/06
Registration timing:prospective
Last update:2023-08-28, 1402/06/06
Update count:0
Registration date
2023-08-28, 1402/06/06
Registrant information
Name
Elahe Ahmadnia
Name of organization / entity
Social determinants of health center
Country
Iran (Islamic Republic of)
Phone
+98 24 3344 9192
Email address
ahmad@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-01, 1402/06/10
Expected recruitment end date
2023-12-01, 1402/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling based on acceptance and commitment on the coping self-efficacy of mothers with unplanned pregnancy
Public title
The effect of counseling based on acceptance and commitment on the coping self-efficacy of mothers with unplanned pregnancy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Pregnant (pregnant age less than 18 weeks)
Having minimum middle school literacy
Satisfaction and willingness to participate in the study
Getting a score of less than 3 based on the London Unplanned Pregnancy Assessment Questionnaire
Exclusion criteria:
Drug abuse and addiction (file and self-report)
Psychological problems (file and self-report)
Chronic debilitating disease (file and self-report)
Incomplete completion of questionnaires
Reluctance to continue cooperation and withdraw from the research
Absence of more than two sessions in counseling sessions
Simultaneous participation in similar training classes or receiving counseling regarding unwanted pregnancy
Stressful experience during the study
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Ardabil city is divided into four regions and two centers are randomly selected from each region according to the resident population, and then those who had unplanned pregnancy will be included in the study according to the available method, and in the next step, people will be allocated in the group. intervention and control will be done by random block method. For this purpose, blocks of 4 will be selected using a table of random numbers in the size of 27 blocks so that the sample size reaches 108 people. Blocking will be done by a person not involved in sampling. Each of the generated random sequences will be recorded on a card and the cards will be placed in the envelopes in order. Finally, the lids of the envelopes will be glued and placed inside a box. At the start of the intervention to identify the order of the participants, one of the envelopes will be opened in order and the assigned group of that participant will be revealed.
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
Ethics committee of zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences، Azadi Blvd, Zanjan
City
zanjan
Province
Zanjan
Postal code
4515613191
Approval date
2023-08-17, 1402/05/26
Ethics committee reference number
IR.ZUMS.REC.1402.121
Health conditions studied
1
Description of health condition studied
pregnancy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Chesney coping self-efficacy score
Timepoint
The measure of coping self-efficacy before the intervention, after the intervention and 2 months after the end of the intervention
Method of measurement
Chesney the coping self-efficacy scale will be completed before and after the intervention and 2 months after the end of the intervention
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will participate in counseling sessions in 8 sessions, twice a week in groups of 8 people, each session will be 90 minutes. The classes will be held under the title of counseling based on acceptance and commitment in the form of psycho-educational counseling sessions
Category
Behavior
2
Description
Control group: will receive routine care.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Azadegan Health Center
Full name of responsible person
Dr. Ali Rezaei
Street address
Hafez town, Shahid Nuruddin Ahmadi street, next to the provincial soil mechanic, in front of Laleh restaurant hall
City
Ardabil
Province
Ardabil
Postal code
8599156189
Phone
+98 45 3372 1991
Email
m_daneshjoo@arums.ac.ir
2
Recruitment center
Name of recruitment center
Seyed Hatami Health Center
Full name of responsible person
Zahra Azim Zadeh
Street address
Ba'ath Square towards Khalkhal Road - next to Sadat Mosque
City
Ardabil
Province
Ardabil
Postal code
8599156189
Phone
+98 45 3362 8550
Email
m_daneshjoo@arums.ac.ir
3
Recruitment center
Name of recruitment center
Shahid Beheshti Health Center
Full name of responsible person
Dr. Maysam Sadeghi
Street address
Mashkin gate behind Silo - Daro Pasha Street - next to 115
City
Ardabil
Province
Ardabil
Postal code
8599156189
Phone
+98 45 3346 5012
Email
m_daneshjoo@arums.ac.ir
4
Recruitment center
Name of recruitment center
Shahid Rajaei Health Center
Full name of responsible person
Leila Dehghan
Street address
Rajaei town, intersection of Shahada and Mehr streets, next to pharmaceutical warehouse
City
Ardabil
Province
Ardabil
Postal code
8599156189
Phone
+98 45 3382 2242
Email
m_daneshjoo@arums.ac.ir
5
Recruitment center
Name of recruitment center
Abu Talib Health Center
Full name of responsible person
Maryam Bakshi
Street address
Hakim Nizami Square - Abu Talib St. - 3
City
Ardabil
Province
Ardabil
Postal code
8599156189
Phone
+98 45 3362 1747
Email
m_daneshjoo@arums.ac.ir
6
Recruitment center
Name of recruitment center
Shahid bakeri Health Center
Full name of responsible person
Nasrin Amoui
Street address
University Street - next to the guard of Ardabil University of Medical Sciences
City
Ardabil
Province
Ardabil
Postal code
8599156189
Phone
+98 45 3351 6573
Email
m_daneshjoo@arums.ac.ir
7
Recruitment center
Name of recruitment center
Khairin Salamat Ardabil Health Center
Full name of responsible person
Zahra Ardilo
Street address
Sina Town - Sina Square - Madar Street - next to Hazrat Abulfazl Mosque
City
Ardabil
Province
Ardabil
Postal code
8599156189
Phone
+98 45 3382 3907
Email
m_daneshjoo@arums.ac.ir
8
Recruitment center
Name of recruitment center
Shahid Bahonar Health Center
Full name of responsible person
Leila Haji Shahmohammadi
Street address
Salman Abad has not reached Mirsharf - Tharullah Alley - next to Ayatollah Moruj High School
City
Ardabil
Province
Ardabil
Postal code
8599156189
Phone
+98 45 3347 5121
Email
m_daneshjoo@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
dr. Samad Nadri
Street address
آدرس خیابان Zanjan University of Medical Sciences، Azadi Blvd, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8300
Fax
+98 24 3314 8300
Email
nadri_s@zums.ac.ir
Grant name
Thesis
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Masumeh Rabiye
Position
Master's student in counseling in midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Experts Phase 2, No. 285, 3 Pone Alley, Farhang St
City
Ardabil
Province
Ardabil
Postal code
5615846767
Phone
+98 45 3372 9727
Email
M.midwife2012@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Elaha Ahmadnia
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Gavazang Road, Zanjan University of Medical Sciences
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 24 3314 8300
Email
Ahmad@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Elahe Ahmadnia
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Zanjan University of Medical Sciences. Midwifery Department
City
zanjan
Province
Zanjan
Postal code
۴۵۱۳۹۵۶۱۱۱
Phone
0243344373
Email
ahmadnea52@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
A piece of data such as information about the main outcome or the like
When the data will become available and for how long
The access period starts one year after the results are published as an article
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to complete the information
From where data/document is obtainable
Researcher and supervisor
What processes are involved for a request to access data/document