Determining the effect of counseling with a positive approach on anxiety and health functions, maternal-fetal attachment, depression, and pregnancy anxiety in Renan with unplanned pregnancy and women with an unplanned pregnancy.
Design
A randomized controlled clinical trial with intervention and control groups
Settings and conduct
For the intervention group (27 women), seven individual counseling sessions (60-90 minutes) will be conducted. Meetings will be held once a week for consecutive weeks. The place of consultation will be the consultation room in the nearest health center to the place of residence of the participants. In the present study, the control group (27 women) will receive the usual pregnancy care
Participants/Inclusion and exclusion criteria
Entry criteria include: married women aged 18-49 with unplanned pregnancy, ability to communicate, gestational age 20-24 weeks, scoring less than 140 in the health function questionnaire and 19-8 in the DASS21 questionnaire.
Exclusion criteria include: fetal abnormalities, high-risk pregnancy including diabetes, high blood pressure, chronic diseases affecting pregnancy, history or current suffering from mental problems, experience of an unfortunate accident during the last six months.
Intervention groups
The intervention group includes 27 women with unplanned pregnancy who receive 7 individual counseling sessions with a positive approach.
The control group is 27 women with unplanned pregnancy who will receive routine pregnancy care
Main outcome variables
general anxiety and health practices
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171007036615N10
Registration date:2023-01-14, 1401/10/24
Registration timing:prospective
Last update:2023-01-14, 1401/10/24
Update count:0
Registration date
2023-01-14, 1401/10/24
Registrant information
Name
عصمت مهرابی
Name of organization / entity
دانشگاه علوم پزشکی تبریز
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 0649
Email address
mehrabie@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling with positive approach on anxiety and health functions of women with unplanned pregnancy, a randomized controlled trial study
Public title
The effect of counseling with positive approach on anxiety and health functions of women with unplanned pregnancy, a randomized controlled trial study
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married women aged 18-49 years
Women with unplanned pregnancy
Gestational age 20to 24 weeks
Verbal and listening ability (ability to communicate)
Obtaining a score less than 50% of the average scores obtained by the participants in the questionnaire of health functions
Obtaining an anxiety score of 8-19 in the anxiety, stress, depression questionnaire (DASS21)
Exclusion criteria:
Fetal abnormalities
Having a high-risk pregnancy includes diabetes, high blood pressure, chronic diseases that affect pregnancy, such as heart, vascular, lung disease, etc
History or current suffering from mental problems or history of hospitalization in a psychiatric hospital
Experiencing an unfortunate incident in the last six months, including the death of relatives
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
The participants were allocated to two groups receiving counseling and control through random block classification based on the type of unplanned pregnancy (unwanted or untimely) using RAS software with blocks of 4 and 6 with a ratio of 1:1. The type of allocation will be written on paper and placed in opaque envelopes numbered consecutively (Allocation Concealment). Random allocation will be done by a person not involved in sampling and data collection. The envelopes will be opened by a person not involved in sampling (an expert from the health center) in the order in which people enter the research, and the type of group of people will be determined
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
دانشگاه علوم پزشکی تبریز (کمیته اخلاق در پژوهش)
Street address
South Shariati Street, Faculty of Nursing and Midwifery, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2022-12-04, 1401/09/13
Ethics committee reference number
IR.TBZMED.REC.1401.806
Health conditions studied
1
Description of health condition studied
general anxiety
ICD-10 code
ICD-10 code description
2
Description of health condition studied
health practicess
ICD-10 code
ICD-10 code description
3
Description of health condition studied
mother- fetal attachment
ICD-10 code
ICD-10 code description
4
Description of health condition studied
pregnancy anxiety
ICD-10 code
ICD-10 code description
5
Description of health condition studied
depression
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
health practices score
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
Health Practices Questionnaire-II: HPQ-II
2
Description
general anxiety score
Timepoint
Before the intervention and 4 weeks after the intervention
Method of measurement
Anxiety part of Depression, Anxiety and Stress Scale - 21 Items:DASS21
Secondary outcomes
1
Description
mother- fetal attachment score
Timepoint
Before the intervention and 4 weeks after the end of the intervention
Method of measurement
MFAS: Mother-fetal attachment scale
2
Description
pregnancy anxiety score
Timepoint
Before the intervention and 4 weeks after the end of the intervention
Method of measurement
Revised Pregnancy Related Anxiety Questionnaire: PRAQ-R2)
3
Description
depression
Timepoint
Before the intervention and 4 weeks after the end of the intervention
Method of measurement
the edinburgh postnatal depression scale
Intervention groups
1
Description
Intervention group: The intervention group (27 women) will receive seven individual counseling sessions (60-90 minutes). Meetings will be held once a week for consecutive weeks. The place of consultation will be the nearest health center to the place of residence of the participants
Category
Behavior
2
Description
Control group: The control group (27 women) will receive usual pregnancy care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
shahid teymouri health center
Full name of responsible person
dr. kolsoom masoumi jarchloo
Street address
behind jahad keshaverzi, amirkabir alley , not far from firooz alley , lale inter section , tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3443 8061
Email
fateme.mirzaloo77784@gmail.com
2
Recruitment center
Name of recruitment center
Marandian Health Center
Full name of responsible person
Dr. Laleh Sadeghi
Street address
Haj Ghaffar Alley, old 17 Shahrivar St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3555 3015
Email
fateme.mirzaloo77784@gmail.com
3
Recruitment center
Name of recruitment center
Eram Health Center
Full name of responsible person
Dr. Elham Gholamalipour
Street address
Al-Mahdi Street, District 8, Eram Town, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 2334
Email
fateme.mirzaloo77784@gmail.com
4
Recruitment center
Name of recruitment center
Manzaria Health Center
Full name of responsible person
Dr. Mohammad Reza Mohammad Alizadeh Niaz
Street address
Etesami Alley, Abadani Maskan, Abu Rihan Crossroads, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 2334
Email
fateme.mirzaloo77784@gmail.com
5
Recruitment center
Name of recruitment center
Shahid Monampour Health Center
Full name of responsible person
Dr Ali Agahi
Street address
Saffron, Saffron Bazaar
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3331 8281
Email
fateme.mirzaloo77784@gmail.com
6
Recruitment center
Name of recruitment center
Ibn Sina Health Center
Full name of responsible person
Dr. Ahmad Namdari
Street address
in front of Imam Hossein Mosque, 18 meters from Idem, Taleghani town, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6151
Email
fateme.mirzaloo77784@gmail.com
7
Recruitment center
Name of recruitment center
Noor Health Center
Full name of responsible person
Dr. Hamid Mottaghi Khosroshahi
Street address
8th Negarestan St. (Fajr), Noor Town, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3448 5638
Email
fateme.mirzaloo77784@gmail.com
8
Recruitment center
Name of recruitment center
Shahid Yahyawi Health Center
Full name of responsible person
Dr. Mahtab Montazer Bavil Aliai
Street address
Azadi St., Shahid Jediri St., Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3334 0444
Email
fateme.mirzaloo77784@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Parviz Shahabi
Street address
Vice Chancellor for Technology Research, Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
fateme.mirzaloo77784@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Esmat Mehrabi
Position
Ph.D in reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
b.mehrabi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Esmat Mehrabi
Position
Ph.D in reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
خیابان شریعتی جنوبی
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
b.mehrabi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Esmat Mehrabi
Position
Ph.D in reproductive health
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
خیابان شریعتی جنوبی
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
b.mehrabi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD