Determining the effect of counseling based logo therapy on anxiety and adaptation to unplanned pregnancy
Design
A controlled, parallel-group, single-blind clinical trial on 52 pregnant women
Settings and conduct
It will be referred to the health centers of Tabriz city, where the details of all women of reproductive age, are available in the web-based system (sib system). The researcher will select the centers from among the centers located in different areas of Tabriz city and the centers with high referrals and will extract the list of all pregnant women 16-24 weeks along with their phone numbers and addresses. In the first stage, centers are selected in a classified manner from different parts of the city with different economic conditions and samples will be selected as available in each center. Then they will be contacted by phone and a brief explanation of the goals and methods of the research will be given. If there is an unplanned pregnancy, people will be requested to be present at the health center at a certain time based on their willingness to participate in the study. In the briefing session, the criteria for entering the study will be reviewed to some extent, and if the women are eligible, the study method will be explained to the participants and the anxiety part of the DASS21 (Depression, Anxiety and Stress Scale - 21 Item) questionnaire will be completed by them.
Participants/Inclusion and exclusion criteria
Married women aged 18-49 years
Women with an unplanned pregnancy with a decision to continue the pregnancy with a gestational age of 16 to 24 weeks
Ability to communicate
Women whose anxiety score is between 8-19 (mild, moderate, severe anxiety) in the DASS-21 questionnaire
Intervention groups
Intervention group: will receive counseling based on logo therapy
Control group: routine prenatal care
Main outcome variables
anxiety and coping
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231107059988N1
Registration date:2023-11-25, 1402/09/04
Registration timing:registered_while_recruiting
Last update:2023-11-25, 1402/09/04
Update count:0
Registration date
2023-11-25, 1402/09/04
Registrant information
Name
Fereshteh Baghaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3367 0906
Email address
fereshtehbaghaei79@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-05-20, 1403/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of logo therapy on anxiety and coping with unplanned pregnancy: a randomized controlled trial
Public title
The effect of logo therapy on anxiety and coping with unplanned pregnancy: a randomized controlled trial
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Married women aged 18-49 years
Women with an unplanned pregnancy with a decision to continue the pregnancy with a gestational age of 16 to 24 weeks
Ability to communicate
Women whose anxiety score is between 8-19 (mild, moderate, severe anxiety) in the DASS-21 questionnaire
Exclusion criteria:
Cases of fetal abnormalities
Having a high-risk pregnancy including diabetes, high blood pressure, chronic diseases affecting pregnancy such as heart disease, vascular disease, lung disease, etc.
History or current suffering from mental problems or history of hospitalization in a psychiatric hospital (according to the individual's own statement)
Experiencing an unfortunate incident in the last six months, including the death of a loved one
Age
From 18 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
52
Randomization (investigator's opinion)
Randomized
Randomization description
The participants were randomly classified according to the type of unplanned pregnancy (unwanted or mistimed) using RAS software with blocks of 6 with a ratio of 1:1. Two groups receiving counseling and control will be assigned. 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)
Single blinded
Blinding description
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Tabriz University of Medical Sciences
Street address
College of Nursing and Midwifery-Southern Shariati Street-Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Approval date
2023-11-06, 1402/08/15
Ethics committee reference number
IR.TBZMED.REC.1402.590
Health conditions studied
1
Description of health condition studied
Unplanned pregnancy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety
Timepoint
At the beginning of the study and 4 weeks after the end of the intervention
Method of measurement
DASS-21 questionnaire
2
Description
Coping
Timepoint
At the beginning of the study and 4 weeks after the end of the intervention
Method of measurement
Revised pregnancy coping inventory: NU-PCI
Secondary outcomes
1
Description
Health practice
Timepoint
At the beginning of the study and 4 weeks after the end of the intervention
Method of measurement
Health Practices Questionnaire-II: HPQ-II
2
Description
Quality of life in pregnancy
Timepoint
At the beginning of the study and 4 weeks after the end of the intervention
Method of measurement
QOL-GRAV: Quality of life-Gravity
Intervention groups
1
Description
Intervention group: the intervention group (26 women), meetings will be held in groups of 3-5 people once a week for consecutive weeks. The place of consultation will be the nearest health center to the place of residence of the participants and duration of sessions are 45-60 minute
Category
Behavior
2
Description
Control group: routine pregnancy care for 26 women in control group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Eram health facility
Full name of responsible person
Dr.Elham Gholamalipour
Street address
Al-Mahdi St,District 8,Aram town
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3232 5148
Email
fereshtehbaghaei79@gmail.com
2
Recruitment center
Name of recruitment center
Babaei health facility
Full name of responsible person
Dr.Alireza Motahhari
Street address
Parvaz-Abbas Duran St., 5 Babaei
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3385 1115
Email
fereshtehbaghaei79@gmail.com
3
Recruitment center
Name of recruitment center
Sajjadiyeh health facility
Full name of responsible person
Dr.Sadaf Jalilzadeh
Street address
58 / 5,000 Translation results Translation result Shahid Montazeri street, 20 meter street, next to Hazrat Abulfazl mosque -
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3544 7281
Email
fereshtehbaghaei79@gmail.com
4
Recruitment center
Name of recruitment center
Qom-tappeh health facility
Full name of responsible person
Dr.Elnaz Afsar
Street address
Qarabaghi St., Serah Beheshti, next to Al-Mahdi Mosque
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3235 7615
Email
fereshtehbaghaei79@gmail.com
5
Recruitment center
Name of recruitment center
Emamiyyeh health facility
Full name of responsible person
Dr.Mandana Abbaszadeh
Street address
At the end of Imamiya, West Meraj St., next to Sepeh Bank, Shahid Soleimani St.
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3541 9330
Email
fereshtehbaghaei79@gmail.com
6
Recruitment center
Name of recruitment center
Andisheh health facility
Full name of responsible person
Dr.Mahmood Hajirostamloo
Street address
Andisheh town, Mardani Azar street, next to the emergency department
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3437 3583
Email
fereshtehbaghaei79@gmail.com
7
Recruitment center
Name of recruitment center
Shahidan Ebrahimi Health facility
Full name of responsible person
Dr.Haniyeh Mahamfar
Street address
University alley, towards Pish qadam Square, not reaching Sari Zami, in front of the CNG station
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3544 7281
Email
fereshtehbaghaei79@gmail.com
8
Recruitment center
Name of recruitment center
Shahid Sabouri Health Facility
Full name of responsible person
Dr.Hossein Yaghchi
Street address
Abbasi Street, Tawanir, towards the highway, in front of the park
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3656 7146
Email
fereshtehbaghaei79@gmail.com
9
Recruitment center
Name of recruitment center
Cheshm andaz health facility
Full name of responsible person
Dr.Zahra Seydian
Street address
Chahar Rah Abbasi, Haj Hashem station, below Chashmaz Park
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3655 4908
Email
fereshtehbaghaei79@gmail.com
10
Recruitment center
Name of recruitment center
Seyed Bawafa Health Center
Full name of responsible person
-
Street address
Munjem Blvd.-lower than Alavi Hospital-one shop-facing the gas station
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3266 1377
Email
fereshtehbaghaei79@gmail.com
11
Recruitment center
Name of recruitment center
Akhmaqayeh Health Center
Full name of responsible person
Dr.Mozhan Manouchehri
Street address
Akhmaqayeh - the last station - next to the center of virtue
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3424 1660
Email
fereshtehbaghaei79@gmail.com
12
Recruitment center
Name of recruitment center
Abuzar Health Center
Full name of responsible person
-
Street address
The end of Sarbaz Shahid street, Sila bazaar to Mulla Zainal, above Abuzar Mosque
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3528 9585
Email
fereshtehbaghaei79@gmail.com
13
Recruitment center
Name of recruitment center
Jamshid Abad Health Center
Full name of responsible person
Dr.Shahin Khabbazi
Street address
Hojjati St., Fayzieh East Intersection, in front of Shohday Hojjati St
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3280 8035
Email
fereshtehbaghaei79@gmail.com
14
Recruitment center
Name of recruitment center
Hokm abad Health Center
Full name of responsible person
Dr.Dadashi
Street address
Bahar St., in front of Asadabadi Hospital, Kaziyar Alley, below Melli Bank
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3281 4854
Email
fereshtehbaghaei79@gmail.com
15
Recruitment center
Name of recruitment center
Ostad Jafari Health Center
Full name of responsible person
Dr.Farzad Madadi
Street address
Hojjati St., Moalem Blvd., Akhar Razi St., next to Sabzezar Park
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3286 1666
Email
fereshtehbaghaei79@gmail.com
16
Recruitment center
Name of recruitment center
Sadeghi Nejad Health Center
Full name of responsible person
Dr.Hakimeh Kabiri
Street address
Hojjati Road, Najjarabad Station, in front of Marandi Alley, next to Khorram Rooz Confectionery
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3288 3925
Email
fereshtehbaghaei79@gmail.com
17
Recruitment center
Name of recruitment center
Sayyad Shirazi Health Facility
Full name of responsible person
Dr.Sonia Ahmadzadeh
Street address
Rezvanshahr, in front of Aghavandi alley
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3235 2121
Email
fereshtehbaghaei79@gmail.com
18
Recruitment center
Name of recruitment center
Khatib Health Facility
Full name of responsible person
-
Street address
Khatib, 12 meters Azari, 12 meters Shabnam, in front of the park
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3438 0725
Email
fereshtehbaghaei79@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 President of Technology Research, Tabriz University of Medical Sciences, Tabriz University, Tabriz University
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3334 4280
Email
fereshtehbaghaei79@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
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
Parisa Yavari kia
Position
Instructure
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
South Shariati St
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
p_k_hn@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parisa Yavari Kia
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
p_k_hn@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Parisa Yavari Kia
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
South Shariati Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138947977
Phone
+98 41 3479 6770
Email
p_k_hn@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