Determining the Effect of Spiritual Self-Care on The Level of Distress and Anxiety of Stillbirth Mothers
Design
This study is a clinical trial that has a control and intervention group and will be performed without blinding. Participants are randomly drawn into groups. The number of samples is predicted to fall to 60 people. After the formation of the groups, a spiritual self-care package will be designed based on the interventions of Richards and Bergin (1997) with an Islamic approach. Data collection will be done through two questionnaires of Beck anxiety and Simmons and Gahr distress tolerance and data analysis will be done using SPSS version 26.
Settings and conduct
In the intervention group, 6 sessions of spiritual self-care with Islamic approach were held individually within two weeks and each session lasted 30 to 40 minutes.
Participants/Inclusion and exclusion criteria
Research population: All stillbirth women admitted to the gynecology ward of hospitals under the auspices of the University
Inclusion criteria: stillbirth, minimum literacy, no physical and mental illness, no use of psychedelics, drugs and narcotics
Exclusion criteria: unwillingness to participate in the study and withdrawal from the meetings
Intervention groups
Intervention: 6 sessions of spiritual self-care are held individually within two weeks. Because these mothers are hospitalized for about 2 to 3 days, the first two sessions will be in person and the rest of the sessions will be by phone-video. The sessions will last 30-40 minutes and the presentation will be in the form of lectures, questions and answers, telling stories and anecdotes appropriate to the topic and giving exercises. Control group: First, the questionnaires are completed as a pre-test. Control: They only receive routine care.
Main outcome variables
Distress, Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211007052692N1
Registration date:2021-10-16, 1400/07/24
Registration timing:prospective
Last update:2021-10-16, 1400/07/24
Update count:0
Registration date
2021-10-16, 1400/07/24
Registrant information
Name
Fatemeh Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 4429 5764
Email address
karimif992@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-06-20, 1401/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Spiritual Self-Care on Distress and Anxiety of Stillbirth Mothers
Public title
The Effect of Spiritual Self-Care in Stillbirth Mothers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Birth of a stillborn baby
Gestational age after 24 weeks
Minimum literacy
No chronic physical and mental illness
No history of drug use, psychedelics and narcotics
Exclusion criteria:
Reluctance to participate in the study
Withdraw from participating in self-care programs
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be randomly drawn in the study groups. In this way, after examining the eligible patients and obtaining the satisfaction of the patients, a lottery container with 2 numbers (intervention) and 2 (control) is randomly taken out by the researcher, which indicates the number. Is the group in which it is placed. If the number of samples in each group is completed, that number will be removed from the lottery and this will continue until the required number of samples for both study groups is completed.
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
Mashhad University of Medical Science
Street address
Ibn Sina Street, doctora intersection
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2021-09-14, 1400/06/23
Ethics committee reference number
IR.MUMS.NURSE.REC.1400.047
Health conditions studied
1
Description of health condition studied
Stillbirth
ICD-10 code
Z37.1
ICD-10 code description
Single stillbirth
Primary outcomes
1
Description
Anxiety
Timepoint
Before and after the intervention, 3 weeks after the intervention
Method of measurement
Beck Anxiety Questionnaire
2
Description
Distress
Timepoint
Before and after the intervention, 3 weeks after the intervention
Method of measurement
Simmons and Gahr Emotional Distress Tolerance Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, the questionnaires are completed as a pre-test and 6 sessions of spiritual self-care are held individually within 2 weeks. Because these mothers are hospitalized for about 2 to 3 days, the first two sessions will be in person and the rest of the sessions will be by phone-video. The sessions will last 30-40 minutes and the presentation will be in the form of lectures, questions and answers, telling stories and anecdotes appropriate to the topic and giving exercises. The questionnaires were completed again at the end of the intervention and 3 weeks after the end of the intervention time.
Category
Behavior
2
Description
Control group: First, the questionnaires are completed as a pre-test. The control group will not receive any intervention other than routine care. Questionnaires are completed again 3 weeks later.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Fatemeh Karimi
Street address
Ibn Sina St, Imam Reza Hospital Square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Email
karimif992@mums.ac.ir
2
Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
Fatemeh Karimi
Street address
Ahmadabad St, Ghaem Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3845 3239
Email
karimif992@mums.ac.ir
3
Recruitment center
Name of recruitment center
Hazrat Umm Al-Banin Women's Hospital
Full name of responsible person
Fatemeh Karimi
Street address
Corner of Ayatollah Behjat 16- Hazrat Umm Al-Banin Women's Hospital
City
Mahhad
Province
Razavi Khorasan
Postal code
٩١۴۴٧٣۴٧۶٧
Phone
+98 51 3223 1061
Email
karimif992@mums.ac.ir
4
Recruitment center
Name of recruitment center
Mehr Hospital
Full name of responsible person
Fatemeh Karimi
Street address
Al-Nandasht Square, Mehr Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
۳۸۴۰۰۴۶۸
Phone
+98 51 3842 7014
Email
karimif992@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayyur Mobarehan
Street address
University St
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Karimi
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ibn Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
karimif992@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Naghmeh Razaghi
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ibn Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
razaghin@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Karimi
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Ibn Sina Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
karimif992@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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