Determining the effect of spiritual intervention on quality of life and life expectancy of women after hysterectomy
Design
This study is non-blinded clinical trial with control group.The study population will be included all women candidates for hysterectomy referring to women's ward of Imam Reza hospital of Kermanshah.60 eligible patients will be selected conveniently and randomly will be assigned to intervention and control groups.
Settings and conduct
This study which will be conducted in Imam Reza hospital of Kermanshah is one-blinded one.Before the study and 4 weeks after the last session, the questionnaire of quality of life and life expectancy will be provided to patients, and both groups will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Literacy; Not participate in similar classes;Do not have mental illness; Not being treated with chemotherapy and radiotherapy
Exclusion criteria: Do not attend more than two sessions in intervention; Experience a psychological crisis during the study
Intervention groups
The intervention group for 8 sessions of 1.5 hours (weekly sessions) will received group spiritual intervention with groups of 12 to 15 people. The control group will not receive any intervention
Main outcome variables
Quality of life; Life expectancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181223042078N1
Registration date:2019-06-03, 1398/03/13
Registration timing:retrospective
Last update:2019-06-03, 1398/03/13
Update count:0
Registration date
2019-06-03, 1398/03/13
Registrant information
Name
Mahin Hemati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3729 2820
Email address
mahinhemati1367@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-18, 1397/11/29
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of spiritual intervention on quality of life and life expectancy of women after hysterectomy
Public title
Study of the effect of spiritual intervention on quality of life and life expectancy of women after hysterectomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Literacy
Not participate in similar classes
Not have a psychological crisis during the study
Not treated with chemotherapy and radiotherapy
Do not use drugs
Do not have mental illness
Exclusion criteria:
Do not attend more than two sessions in intervention
Experience a psychological crisis during the study
Age
From 20 years old to 70 years old
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
Simple accident
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 Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-12-05, 1397/09/14
Ethics committee reference number
IR.KUMS.REC.1397.702
Health conditions studied
1
Description of health condition studied
Hysterectomy
ICD-10 code
Z90.7
ICD-10 code description
Acquired absence of genital organ(s)
Primary outcomes
1
Description
Quality of Life
Timepoint
Before the intervention begins, 2 months after the intervention begins
Method of measurement
Based on World Health Organization Quality of Life Questionnaire
2
Description
Hope of Life
Timepoint
Before the intervention begins, 2 months after the intervention begins
Method of measurement
Base on Snyder's Hope Scale
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group for 8 sessions of 1.5 hours (weekly sessions) will received group spiritual intervention with groups of 12 to 15 people.
Category
Lifestyle
2
Description
The control group will not receive any intervention
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza Hospital
Full name of responsible person
Mahin Hemmati
Street address
Emam Reza Hospital, Parastar Boulevard
City
kermanshah
Province
Kermanshah
Postal code
67196-64939
Phone
+98 83 3729 2820
Email
mahinhemati1367@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Amir Jalali
Street address
Government of the Faculty of Nursing and Midwifery
City
kermanshah
Province
Kermanshah
Postal code
67196-64939
Phone
+98 83 3729 2820
Email
a_jalali@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Mahin Hemmati
Position
Student of Psychiatric Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Emam Reza Hospital, Parastar Boulevard
City
kermanshah
Province
Kermanshah
Postal code
67196-64939
Phone
+98 83 3729 2820
Email
mahinhemati1367@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Amir Jalali
Position
Member of the faculty of Kermanshah University of Medical Sciences
Latest degree
Master
Other areas of specialty/work
Nursing education
Street address
Faculty of Nursing and Midwifery, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
67196-64939
Phone
+98 83 3826 1083
Email
a_jalali@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mahin Hemmati
Position
Psychiatric Nursing Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Emam Reza Hospital, Parastar Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
67196-64939
Phone
+98 83 3729 2820
Email
mahinhemati1367@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD