Main purpose: To determine the effect of spiritual therapy on resilience of mother's following abortion
Sub-objective: 1) Determining and comparing the average resilience score mothers following abortion in the intervention and control group before the intervention
2) Determining and comparing the average resilience score of mothers following abortion in the intervention and control group after the intervention
3) Determining and comparing the average resilience score of mothers following abortion in the intervention and control group before and after the intervention
Design
Random clinical trial with control group- without blinding- on 68 patients. the individuals are divided into intervention and control groups using random blocking
Settings and conduct
The research environment will be Al-Zahra hospital in rasht. The sessions will be held in 8 sessions for 4 weeks (twice weeks). the duration of the sessions will be 60 minutes
Participants/Inclusion and exclusion criteria
Entry conditions: Abortion before 20 weeks- minimum literacy- lack of known physical and psychiatric illenss based on the patient's statement and not taking medication related to these illnessess- willingness to participate in the study
Eixt conditions: Reluctance to continue participating in the study- failure to attend more than two training sessions
Intervention groups
Spiritual therapy will be performed in 8 sessions for 4 weeks (twice a week). The duration of the sessions will be 60 minutes. meeting will be based on the protocal Kajbaf et al. the control group will receive routine care and will be given a spiritual therapy protocol at the end of the work
Main outcome variables
resilience mothers following abortion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160821029446N11
Registration date:2022-03-07, 1400/12/16
Registration timing:prospective
Last update:2022-03-07, 1400/12/16
Update count:0
Registration date
2022-03-07, 1400/12/16
Registrant information
Name
Maryam Damghanian
Name of organization / entity
Nursing and Midwifery Faculty, Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
m-damghanian@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of spiritual therapy on resilience of mothers following abortion
Public title
the effect of spiritual therapy on resilience
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Abortion before 20 weeks
Minimum literacy
No physical or psycholigical illness based on the patient's statement and no medication associated with the illness
Willingness to participate in the study
Exclusion criteria:
Having a physical and psychological illness based on the patients statement
selective abortion
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of samples to intervention (A) and control (B) groups (34 people in each group) will be done using blocks with size of 4. In this way, 6 possible modes will be considered using a table of random numbers. These 6 modes are written on 6 separate cards and the cards will be placed in a black bag (for concealment) . A card will be issued for 17 times to finally get 68 letters written as the sample size. The intervention group will be the group that will receive spiritual therapy sessions, and the control group will be the group that will receive only the routine cares.
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 the School of Nursing and Midwifery and the School of Rehabilitation of Tehran U
Street address
Tohid Square,Dr. Mir Khani St.(Eastern Nursat)
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2022-01-13, 1400/10/23
Ethics committee reference number
IR.TUMS.FNM.REC.1400.185
Health conditions studied
1
Description of health condition studied
abortion
ICD-10 code
O03
ICD-10 code description
Spontaneous abortion
Primary outcomes
1
Description
THe resilience score that individuals obtain from the Connor and Davidson Resilience Questionnaire
Timepoint
Before the intervention and at the end of the eighth session
Method of measurement
Connor and Davidson Resilience Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: individuals are trained in spiritual therapy in 8 sessions (twice a week) for 4 weeks for 60 minutes. Once before the intervention and once after the training sessions, the reliance questionnaire will be filled out by the intervention group,. spiritual therapy training will be provided based on the package of kajbaf et al. the content of the meetings is as follows.session1: in this session, hope and empathetic relationship are discussed. Session 2: In this session, the first premise (spiritual human being) and the second premise that pleasant and unpleasant feelings are not dependent on phenomena but on inner feelings will be discussed. In this session, the promotion of intentions and purposeful behaviors and positive mental imagery towards God will be taught. Session 3: Includes the third premise which is the principle of action. This principle is based on the attributes of God's mercy and generosity. That is, God always provides the opportunity for human growth, and the fourth premise (divisibility: means that worldly affairs can be divided into changeable and immutable affairs). Session 4: In this session, the fifth premise (the moral world is created and always moving in the direction of happiness) will be taught. The strategy of prayer and its place in human life and increasing women's resilience following abortion and reducing anxiety and stress will be taught. Session 5: It is based on the principle that the future is not entirely in our hands. In this session, the strategies of remembrance, trust and hope in God will be discussed. Session 6: It is based on the principle that man is constantly in touch with God. In this session, the position of patience as a strategy to increase women's resilience following abortion, increase the quality of married life and deal with anxiety will be taught.Session 7: It is based on this principle that the eighth premise (spiritual man lives with his attributes, not with his property and possessions) and the ninth premise (achieving spiritual life requires charity, forgiveness, forgiveness and love). Session 8: Default (understanding the meaning of hardships and responsibilities to God, self, others and the universe).
Category
Treatment - Other
2
Description
Control group: No action is taken for members of the control group. These people receive hospital routine care. Once before the intervention in the intervention group and once after the training sessions in the intervention group, the reliance questionnaire will be filled out by the control group.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-Zahra hospital
Full name of responsible person
Maryam Damghanian
Street address
Namjoo st, in front of shahid Azdi Stadium, Al-Zahra Medical Training Center
City
Rasht
Province
Guilan
Postal code
54829-41446
Phone
+98 13 3336 9326
Email
azzahra@gums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehrnaz Geranmaye
Street address
Keshavarz Blvd., Vesal Shirazi St., Italy St., No. 41, Comprehensive Research Laboratory, Negative First Floor, Preclinical Laboratory
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 8897 8745
Email
info@tpcf.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Maryam Damghanian
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Tohid Square, Dr. Mirkhani St (Eastern Nusrat
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
fnm@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Damghanian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Tohid Square, Dr. Mirkhani St. (Eastern nusrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
021669271171
Email
fnm@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Damghanian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Tohid Square, Dr. Mirkhani St (Eastern Nusrat)
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
fnm@tums.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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
information about the main outcome can be shared
the protocol used in this intervention
When the data will become available and for how long
6 months after printing the resuits
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
for use in articles
From where data/document is obtainable
Dr.Maryam Damghanian
maryamdamghanian@gmail.com
What processes are involved for a request to access data/document
the applicant must notify the e-mail of the request for use and after review,their request will be answered