The effect of counseling on childbirth satisfaction in primiparous women based on Fordyce's happiness model in mothers referring to Zanjan health centers in 1401
Design
clinical trial with a control group, randomized, sample size= 80 people
Settings and conduct
Sampling will be done in Zanjan comprehensive health centers. 4 centers for the intervention group and 4 centers for the control group were selected by lottery. in the selected centers, Pregnant women, who meet the inclusion criteria, will be selected by simple random method. From the 29th week of pregnancy, the intervention group will receive group counseling based on Fordyce's happiness model. there is no blinding.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
age range from 18 to 42; Obtaining a score lower than 12.5 in the Edinburgh depression questionnaire; Absence of serious underlying disease; A healthy fetus without abnormalities and a singleton
Exclusion criteria:
People who do not want to continue participating in the study; People who do not participate in more than one counseling session; the occurrence of stressful events; Elective and emergency cesarean sections
Intervention groups
From the 29th week of pregnancy, the intervention group will receive Fordyce's happiness group counseling in 6 sessions virtually (twice a week) and consecutively for 60-90 minutes using the WhatsApp application and sending clips and pictures in groups of 8 people. did At the same time, the control group will also receive routine prenatal care. In order to comply with ethics, after completing the study, all the educational videos prepared by me will be available to the control group
Main outcome variables
The level of satisfaction with childbirth; the level of happiness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201113049377N2
Registration date:2022-09-06, 1401/06/15
Registration timing:prospective
Last update:2022-09-06, 1401/06/15
Update count:0
Registration date
2022-09-06, 1401/06/15
Registrant information
Name
Parvin Mohebbi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3344 6258
Email address
p.mohebbi11@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-16, 1401/06/25
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of counseling on childbirth satisfaction in primiparous women based on Fordyce's happiness model
Public title
The effect of counseling on childbirth satisfaction based on Fordyce's happiness model
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Age range 18 to 42
Having the facilities and literacy to use the internet network in virtual space
Obtaining a score lower than 12.5 in the Edinburgh Depression Questionnaire
A singleton fetus (because Multiple pregnancy are candidates cesarean births and will be excluded from the study)
Healthy fetus with no abnormalities
No history of serious illness (heart, vascular, chronic kidney disease)
Absence of psychological disorders
Absence of drug, alcohol and street drug use
Exclusion criteria:
People who do not want to continue participating in the study
People who do not participate in more than one counseling session
Existence of mental disorders based on mothers' self-report
Occurrence of stressful events in the research process such as: death of loved person, accident, separation from spouse and migration
Elective and emergency cesarean sections such as bleeding, dystocia, meconium
Age
From 18 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done by multi-stage random allocation. In the first stage, each urban area is considered as a cluster. There are a total of 22 comprehensive health centers and bases in Zanjan city, which are located in 4 urban areas. Then, from each cluster, two comprehensive health centers (one intervention center, one control center) will be selected by a simple random method through lottery. Based on this, we will have 8 comprehensive health centers, 4 centers for the intervention group and 4 centers for the group. will be controlled. In this way, the names of both centers are written on two separate sheets and placed in the lottery bag, then the first paper removed will be assigned to the intervention group and the remaining paper to the control group. In the next stage, in the selected centers, eligible pregnant women will be selected by a simple random method, and mothers who are in the twenty-ninth week of pregnancy and are willing to participate in the study and meet the inclusion criteria will be included in the study.
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
کمیته اخلاق دانشگاه علوم پزشکی زنجان
Street address
No. 3539, Badr 9 Ave, Zanjan city
City
زنجان
Province
Zanjan
Postal code
4514913459
Approval date
2022-08-23, 1401/06/01
Ethics committee reference number
IR.ZUMS.REC.1401.174
Health conditions studied
1
Description of health condition studied
Satisfaction with childbirth
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Satisfaction with childbirth
Timepoint
24 hours after delivery
Method of measurement
McKay's childbirth satisfaction questionnaire
Secondary outcomes
1
Description
level of Happiness
Timepoint
In the first face-to-face meeting before the consultation, in the 36th week of pregnancy and 24 hours after delivery
Method of measurement
Oxford Happiness Questionnaire
Intervention groups
1
Description
Intervention group: Participants in the intervention group will receive 6 virtual group counseling sessions based on Fordyce's happiness model, weekly and consecutively through the WhatsApp application for 60 to 90 minutes. The duration of the course is three weeks, and the contents of the sessions include the necessity of happiness, teaching the technique of expressing emotions and showing them, the technique of increasing optimism and intimate relationships, avoiding worrying thoughts, coping with stress, planning and the technique of living in the present, The art of being real is to lower expectations and give priority to happiness
Category
Behavior
2
Description
Control group: The control group consists of 40 people who will receive routine pregnancy care that includes measuring vital signs, weight, uterine height, fetal heart rate, examining danger signs and health education, and requesting and reviewing the required para-clinical measures. and in order to comply with ethics, all educational videos prepared by me will be sent to the control group after the study is completed.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Zanjan Comprehensive health centers
Full name of responsible person
Parvin Mohebbi
Street address
No. 3539, Badr 9 Ave, Zanjan city
City
Zanjan
Province
Zanjan
Postal code
4514913459
Phone
+98 24 3344 7611
Email
p.mohebbi11@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr. Samad Nadri
Street address
ZUMS Central Office, Azadi Square, Zanjan, Zanjan.
City
Zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3342 0677
Email
nadri_s@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Elham Bagheri Nia
Position
Msc Student in Midwifery Counseling
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Plot 2174, Golsar Street 3, Phase 2, Golshahr, Zanjan City, Zanjan
City
Zanjan
Province
Zanjan
Postal code
4514198415
Phone
+98 24 3372 6794
Email
eli.midwife73@gail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Parvin Mohebbi
Position
Instructor - Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No. 3539, Badr Ave.
City
Zanjan
Province
Zanjan
Postal code
4514913459
Phone
+98 24 3344 6258
Email
p.mohebbi11@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Parvin Mohebbi
Position
Instructor - Faculty member
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
No. 3539, Badr Ave.
City
Zanjan
Province
Zanjan
Postal code
4514913459
Phone
+98 912 442 4883
Email
p.mohebbi11@gmail.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
The possibility of dissatisfaction of the participants