Determining the effect of group hope therapy on the desire to have children in women of reproductive age living in Gonabad city in ؛2023
Design
A randomized, controlled, clinical trial with parallel groups. randomization will be based on the random permutation block method with sizes of 2 and 4.
Settings and conduct
Refer to community health centers in Gonabad city, select samples. Completing the demographic questionnaire, women's propensity to have children, and randomly assigning them to two groups, the intervention group under group hope therapy and the control group, no intervention, and again completing the questionnaires and analyzing the data.
Participants/Inclusion and exclusion criteria
Having a wife alive and without fertility problems
Age 18-50 years
Obtaining a medium to low level of hope from Schneider's Hope Questionnaire
Expression of desire to participate in this intervention
Being of Iranian origin
Living in Gonabad
Being literate in reading and writing
Having one to three children who are at least 1 year older than the last child.
Not wanting to have children at the beginning of the study
Not being menopause
Not suffering from known or self-reported mental illnesses
Not having any medical contraindications for pregnancy and childbearing
Not having children with mental and physical disabilities
No facing an unfortunate event recently
Not having visual or auditory speech defects
Not suffering from infertility or frequent miscarriage
Intervention groups
The intervention group will participate in group hope therapy sessions in 8 sessions of 90 minutes.
The control group will be without any intervention.
Main outcome variables
Desire to have children
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230524058284N1
Registration date:2023-07-08, 1402/04/17
Registration timing:registered_while_recruiting
Last update:2023-07-08, 1402/04/17
Update count:0
Registration date
2023-07-08, 1402/04/17
Registrant information
Name
Maryam Maleki mogadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3222 2192
Email address
m.maleky947@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-02, 1402/04/11
Expected recruitment end date
2023-08-02, 1402/05/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group hope therapy on the desire to have children in women of reproductive age .
Public title
The effect of group hope therapy on the desire to have children in women of reproductive age .
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a wife alive and without fertility problems
Age 18-50 years
Obtaining a medium to low level of hope from Schneider's Hope Questionnaire
Expressing the desire to participate in this intervention
Being of Iranian origin
Living in Gonabad city
Being literate in reading and writing
Having one to three children who are at least 1 year older than the last child
Exclusion criteria:
Wanting to have children now (before the study)
Being menopause
Suffering from known or self-reported mental illnesses
Having any medical contraindications for pregnancy and child bearing
Having children with mental and physical disabilities
Has not recently (the last three months) faced an unfortunate events
Having visual or auditory speech defects
Suffering from infertility or frequent miscarriage
Age
From 18 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done by random permutation blocks with size 2 and 4. The randomization list will be determined on the web through the site (https://www.sealedenvelope.com) and by the analyst. In order to hide the allocation, opaque sealed envelopes with random sequence will be used.
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 Gonabad University of Medical Sciences
Street address
Gonabad_side of Asian road_Gonabad University of Medical Sciences_Nursing School_Elham Saberi
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Approval date
2023-06-23, 1402/04/02
Ethics committee reference number
IR.GMU.REC.1402.057
Health conditions studied
1
Description of health condition studied
Desire to have children
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The score of desire to have children in the fertility desire scale (FDS) developed by Nagibi et al.
Timepoint
Before intervention, immediately after intervention and three months after intervention
Method of measurement
The fertility desire scale (FDS) developed by Nagibi et al.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: who will participate in group hope therapy sessions based on the Schneider protocol, which includes 8 90-minute sessions, and the management and leadership of the group is by a nurse with a master's degree in community health, and content training and group discussions of the participants in the meeting are under the responsibility of a senior psychology expert. It is clinical. The main content of each session is as follows. The first session is mutual familiarization of the members with the instructor and the statement of goals and educational program based on Schneider's theory; the second session is an explanation of how to develop hope and the necessity of its existence and its effect on well-being, while establishing a therapeutic relationship. With each of the clients and paying attention to the dynamic process of the group, the third session asks the clients to describe their life stories, the fourth session, the stories are explained based on Snyder's three main components and will be re-formatted. At the same time, there are cases of hope in the life of each member. identified and past successes are taken into account in order to identify factors and passages; in the fifth session, members will be asked to provide a list of current events and important aspects of their lives and determine the importance of each of them; In the sixth session, the characteristics of suitable goals will be presented based on Snyder's theory, and then people will be encouraged to set goals in each of the areas of life. In the seventh session, the characteristics of suitable passages will be presented and they will be asked to reach come up with suitable solutions to the set goals, then we will train them to break the crossings into a series of small steps and determine the replacement crossings; in the eighth session, strategies to create and maintain the agent will be proposed, including asking people to practice mentally what needs to be done to achieve the goals. And finally, they are taught to be a hope healer themselves and use hopeful thinking on a daily basis so that they can determine their own goals and obstacles, create and maintain the necessary factors to achieve them. and recognize the necessary crossings.
Category
Behavior
2
Description
Control group: This group is not subjected to any special intervention.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Health Department of Gonabad medical univercity
Full name of responsible person
Elham Saberi
Street address
Naserkhosroo Ave, Health Department of Gonabad medical univercity
City
Gonabad
Province
Razavi Khorasan
Postal code
۹۶۹۱۷۹۳۷۱۸
Phone
+98 51 5722 3028
Fax
+98 51 5722 0193
Email
saberi.e@gmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Dr. Lily Sadegh Moghadam
Street address
Dr. Lily Sadegh Moghadam,Nursing Faculty,Gonabad side of Asian road, University of Medical Sciences
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3401
Email
LS.MOGHADAM@GMU.AC.IR
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University of Medical Sciences
Full name of responsible person
Elham Saberi
Position
Faculty of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Gonabad_side of Asian road_Gonabad University of Medical Sciences_Nursing School_Elham Saberi
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3401
Email
saberi.e@gmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Elham Saberi
Position
Faculty of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Gonabad_Side of Asian road_Gonabad University of Medical Sciences_Nursing School_Elham Saberi
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3028
Fax
+98 51 5723 6160
Email
saberi.e@gmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Elham Saberi
Position
Master's degree in Community Health Nursing, Faculty of Gonabad University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Gonabad_Side of Asian road_Gonabad University of Medical Sciences_Nursing School_Elham Saberi
City
Gonabad
Province
Razavi Khorasan
Postal code
9691793718
Phone
+98 51 5722 3401
Email
saberi.e@gmu.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The project results will be published as a research paper
When the data will become available and for how long
Since the publication of the article in a reputable journal
To whom data/document is available
All researchers
Under which criteria data/document could be used
To conduct similar and applied research
From where data/document is obtainable
Elham Sabri, member of the faculty of Gonabad University of Medical Sciences
What processes are involved for a request to access data/document
Phone call, visit in person and email and submit a written request