Determining The Effect of Spiritual Education on Coping Strategies in Infertile Women
Design
Quasi-experimental with the control group
Settings and conduct
This study is conducted on 90 infertile women. For prevent data contamination, By drawing method one of the infertility centers is assigned to the test group and the other to the control group, then the sampling will be done in an accessible manner. Demographic questionnaires and coping strategies are completed before and after the intervention and 8 weeks after the completion of the intervention in both groups.
Participants/Inclusion and exclusion criteria
Female infertility; The first marriage of each of the couples; Age of 49-18 years; Non-infertility-related diseases; Passed at least one year after an infertility diagnosis; Non-use of drugs and drugs related to mental disorders; Having at least a reading and writing literacy to complete questionnaires; The lack of education of each of the couples in the fields of theology; The lack of participation of each of the couples in courses or workshops seminary spiritual - religious; Having a Shi'i religion; Not having an adopted; Lack of something bad happening over the last 6 months
Intervention groups
The test group will participate in 6 training sessions of the group for 6 weeks that will be held in the form of a lecture and a question and answer to the questions. The contents of each session will be given to the test group.
The control group will receive the Infertility Center's health care and will receive a training book on spiritual education at the end of the study.
Main outcome variables
The difference or non-difference of Problem- focus coping strategies includes: seeking social support, accepting responsibility, planful problem solving and positive reappraisal, and the Emotion-focus coping strategies includes: confronting, distancing, self-controlling and escape-avoidance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181207041873N2
Registration date:2019-05-28, 1398/03/07
Registration timing:prospective
Last update:2019-05-28, 1398/03/07
Update count:0
Registration date
2019-05-28, 1398/03/07
Registrant information
Name
Seyedeh Batool Hasanpoor-Azghady
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2286 0021
Email address
hasanpoor.sb@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-08, 1398/03/18
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Spiritual Education on Coping Strategies in Infertile Women
Public title
The Effect of Spiritual Education on Coping Strategies in Infertile Women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Female infertility approved by a gynecologist- First marriage of each of the couples-Age of 49-18 years - Non-infertility-related diseases Passed at least one year after an infertility diagnosis. Non-use of drugs and drugs related to mental disorders -Having at least a reading and writing literacy -The lack of education of each of the couples in the fields of theology -The lack of participation of each of the couples in courses or workshops seminary spiritual - religious Having a Shi'i religion -- Not having an adopted - Lack of something bad happening over the last 6 months
Exclusion criteria:
- An unpleasant incident during the research- Getting any psychological treatment before or during the study - Childbirth or adoption during study- Getting out of the process of treating infertility- Not attending more than two training sessions
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:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The introduction of the letter and necessary permits from the university is for the Infertility Centers of Qom Jihad and the Reyhane Infertility Center in Forghani Hospital. After entering the research environment, the researcher will begin to sample the infertility centers after introducing and explaining his goals. In order to prevent data contamination, depending on the nature of the research subject, the sampling site of the two test and control groups is independent of each other. At first, one of the centers of infertility is allocated to the control group as a test site and the other is drawn to the control group by drawing lots. Sampling will be carried out in accessible form and the samples will be in two groups of intervention (n = 45) and control (n = 45). After the necessary explanation of the research, its goals and the confidentiality of the research data, the written samples will be taken from the sample, and demographic questionnaires and coping strategies will be provided to them.
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 Committees of Iran University of Medical Sciences
Street address
Tehran, Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2018-10-28, 1397/08/06
Ethics committee reference number
IR.IUMS.REC.1397.699
Health conditions studied
1
Description of health condition studied
Coping strategies used in infertile women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The difference or non-difference of Problem- focus coping strategies includes: seeking social support, accepting responsibility, planful problem solving and positive reappraisal, and the Emotion-focus coping strategies includes: confronting, distancing, self-controlling and escape-avoidance
Timepoint
Before the intervention, at the end of the last training session and eight weeks after the completion of the training sessions
Method of measurement
Lazarus coping methods questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The test group will participate in a group for 6 weeks in 6 sessions. Each session will run 90 minutes. The number of people in each training group will be six to eight. The two sessions of the six sessions that will be held in the third and sixth weeks will be the subject of theoretical knowledge in the areas of spirituality and religion that will be the main responsibility of the education that the researcher will attend in these two sessions, Training will follow the recommendations of the expert. The tool is used in group video projector (Powerpoint) and whiteboard meetings. The contents of the training sessions will be held at office hours and at the Infertility Center. Each training session is held in the form of a lecture and a question and answer to questions on previously defined topics in the booklet. In the last fifteen minutes, a summary of the contents will be done with the help of research units and the contents of each session will be provided to the test group. The content of the meetings is marked with details in Table (1). Trainings will be provided by the researcher. It should be noted that the researcher will participate in workshops on spiritual training for proper intervention. The test group three times: Before the intervention, at the end of the last training session and eight weeks after the completion of the training sessions, the Lazarus coping strategies questionnaire will be completed. The content of the meetings is specified in the table (1) with details. Trainings will be provided by the researcher. It should be noted that the researcher will participate in workshops on spiritual training for proper intervention. The test group will complete the Lazarus coping strategies questionnaire three times before the intervention, at the end of the last training session and eight weeks after the completion of the training sessions. Discussion 1: Introduction of the researcher and reestablishment of goals, familiarity with the research units, discussion On the dimensions of human existence, especially its spiritual dimension and the needs of each dimension. Session 2: The importance of self-consciousness in the spiritual dimension, talking about the characteristics of the spiritual person, encouraging the patient to reveal the ideas and spiritual experiences themselves. Session 3: Talking about the meaning of life and methods of meaningfulness to life, encouraging research units to positively impart life experiences. Session 4: Methods for raising the religious and spiritual dimension: Encouraging the patient to participate in spiritual-religious programs, going to religious places, joining spiritual groups, assigning time to keep up with God. Session 5: Encourage the patient to use appropriate coping strategies such as trust, patience, forgiveness and the effects of mentioning God. Session 6: Problem-Solving Problem with Spiritual Approach, Completion of Lazarus Coping Strategies Questionnaire by Research Units Control group: The health care center will receive the Infertility Center. The group also completed the questionnaires three times in the study period, at the same time with the test group and will receive a training book on spiritual education (including topics in the training sessions) at the end of the study. The dates for completing the questionnaire will be communicated to each group by telephone call.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Center of Qom University Jihad
Full name of responsible person
Atefe Haji hasan donyadide
Street address
Shahid Karimi Boulevard, Isar Square, Shabna Shrine - Infertility Center, Qom University Jihad
City
Qom
Province
Ghoum
Postal code
3716986466
Phone
+98 25 3784 9250
Email
atefedonyadide@yahoo.com
2
Recruitment center
Name of recruitment center
مرکز ناباروری ریحانه
Full name of responsible person
Atefe Haji hasan donyadide
Street address
Azar Avenue, next to Mirzaee Qomi Square
City
Qom
Province
Ghoum
Postal code
3715873355
Phone
+98 25 3133 8352
Email
atefedonyadide@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sayed Kazem Malekoti
Street address
Tehran, Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86701
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
50
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
Iran University of Medical Sciences
Full name of responsible person
Seyede Batool Hasanpoor-Azghady
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
No. 1996713883, Rashid Yasemi Ave., Valiance Ave., School of Nursing & Midwifery., Tehran Town,
City
Tehran
Province
Tehran
Postal code
1907755551
Phone
+98 21 2286 0021
Email
hasanpoor.sb@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyede Batool Hasanpoor-Azghady
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
No. 1996713883, Rashid Yasemi Ave., Valiance Ave., School of Nursing & Midwifery., Tehran Town,
City
Tehran
Province
Tehran
Postal code
1907755551
Phone
+98 21 2286 0021
Email
hasanpoor.sb@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyede Batool Hasanpoor-Azghady
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
No. 1996713883, Rashid Yasemi Ave., Valiance Ave., School of Nursing & Midwifery., Tehran Town,
City
Tehran
Province
Tehran
Postal code
1907755551
Phone
+98 21 2286 0021
Email
hasanpoor.sb@iums.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
Undecided - It is not yet known if there will be 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
Only part of the information, such as information on the main outcome or the like, can be shared
When the data will become available and for how long
Start the access period 6 months after publishing the results
To whom data/document is available
Data for researchers and people who are engaged in treatment can apply for them
Under which criteria data/document could be used
Data for researchers and people who are engaged in treatment can apply for them
From where data/document is obtainable
by Email atefedonyadide@yahoo.com
What processes are involved for a request to access data/document