determine the effect of Spiritual care education in quality of life in Wives of Veterans with Post Traumatic Stress Disorder
Design
Clinical trial with control group on spouses of veterans with post-traumatic stress disorder and quality of life before, immediately and two months after intervention
Settings and conduct
60 eligible spouses are selected by simple random sampling. The research samples receive 9 training sessions for two consecutive weeks. Participants are evaluated before, immediately and two months after the intervention.
Participants/Inclusion and exclusion criteria
ability to answer questions, informed consent to participate in the study and exclude criteria of the study including: absenteeism in more than two sessions in educational interventions and the willingness to leave the study.
Intervention groups
Interventions (spiritual care education) were performed in group and in 9 sessions for the intervention group and in the control group, routine training is given
Main outcome variables
Quality of Life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130618013710N1
Registration date:2022-07-11, 1401/04/20
Registration timing:registered_while_recruiting
Last update:2022-07-11, 1401/04/20
Update count:0
Registration date
2022-07-11, 1401/04/20
Registrant information
Name
ali meshkinyazd
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1711 0266
Email address
meshkina1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-20, 1401/03/30
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 Impact of Spiritual Care Skills on quality of life in spouses of veterans with Post Traumatic Stress Disorder
Public title
Effect of Spiritual Care Skills on quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
ability to answer questions
informed consent to participate in the study
Exclusion criteria:
receiving psychiatric treatments
absenteeism in more than two sessions in educational interventions
willingness to leave the study
Age
From 18 years old to 60 years old
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
The number of samples was 60. According to the previous studies, 95% confidence interval and using the sample size formula, considering the probability of dropping the research units of 34 in each group (68 in total) Were selected and Were randomly assigned to two groups of 34 person. The odd numbers of the intervention group and the even numbers of the control group. Finally, with the loss of 8 units (4 people due to lack of participation in the workshop, and 4 people due to lack of response to the questionnaire at follow up), 60 (30 in the experimental group and 30 in the control group) in the study Participated.
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 Sciences
Street address
School of Nursing, PhD Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
9196776749
Approval date
2020-11-25, 1399/09/05
Ethics committee reference number
IR. MUMS. REC. 1399. 504
Health conditions studied
1
Description of health condition studied
PTSD
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD)
Primary outcomes
1
Description
Quality of Life
Timepoint
Before and after training, two months after the intervention
Method of measurement
Quality of Life Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: spiritual care training during 9 sessions
Category
Behavior
2
Description
Control group:Routine training during discharge
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn Sina Psychiatric Hospital
Full name of responsible person
Ali Meshkinyazd
Street address
Boulevard Bouali
City
Mashhad
Province
Razavi Khorasan
Postal code
09196776749
Phone
+98 51 3700 2202
Email
Meshkina1@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Abbas Heidary
Street address
School of Nursing, PhD Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
09196776749
Phone
+98 51 3859 1511
Email
ramresearch@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
Ali Meshkinyazd
Position
Nurse
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing, PhD Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
09196776749
Phone
+98 51 3859 1511
Email
Meshkina1@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Meshkinyadz
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mashhad School of Nursing
City
Mashhad
Province
Razavi Khorasan
Postal code
09196776749
Phone
+98 51 3859 1512
Email
Meshkina1@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Meshkinyazd
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mashhad School of Nursing
City
Mashhad
Province
Razavi Khorasan
Postal code
09196776749
Phone
+98 51 3859 1511
Email
Meshkina1@mums.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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All variables collected
When the data will become available and for how long
Since 1401
To whom data/document is available
Available only to members of scientific institutes.
Under which criteria data/document could be used
No condition
From where data/document is obtainable
Via email: meshkina1@mums.ac.ir and Ali Meshkin Yazd will be responsible
What processes are involved for a request to access data/document