Protocol summary

Summary
This study is a clinical trial that randomly assigned to two groups from October to December 1394 martyr Beheshti Hospital of Hamedan on 40 female patients with cancer who were referred to this center. The number of samples in each of 15 groups was determined that the risk of loss or lack of satisfaction in the study, 20 patients in each group were considered. Inclusion criteria included: age 18-65 years, and Shiite Muslim, passing at least 4 months of diagnosis, consent to participate in research, the ability to talk and get on the stage of the End Stage . The study tools were completed by interviewing patients and patients randomly using a table of random numbers in both groups were 21 people intervention and control. Individual spiritual counseling intervention group and 2 times a week and consisted of 8 sessions of 45 minutes in the morning or the evening was. At the end of the intervention and control groups were examined again by the tool The data in this study through spiritual health assessment questionnaire (Paloutzian & Ellison), and demographic information was gathered Demographic information including age, education, social class and income level, number of family members, the company was in religious ceremonies and rites.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015112225187N1
Registration date: 2015-12-23, 1394/10/02
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-12-23, 1394/10/02
Registrant information
Name
Naemeh Niazi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3829 0270
Email address
dr.sajadei@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Spiritual Consultation on The Spiritual Health Of Women With Cancer
Public title
Effect of Spiritual Consultation on The Spiritual Health Of Women With Cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria included: age 18-65 years old and Shiia Muslim; passing at least 4 months of diagnosis; consent to participate in research; the ability to talk and get on the stage of the end stage. Exclusion criteria: lack of consent to continue to participate in research and patient non-compliance in a timely manner to carry out assignments and participation in conferences.
Age
From 18 years old to 80 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hamedan University of Medical Sciences
Street address
Hamedan،Pajuhesh Crossroads، Hamedan University of Medical Sciences
City
Hamedan
Postal code
6517838678
Approval date
2015-07-25, 1394/05/03
Ethics committee reference number
IR.UMSHA.RCE.1394.240

Health conditions studied

1

Description of health condition studied
Cancer
ICD-10 code
C80.0
ICD-10 code description
Malignant neoplasm, primary site unknown, so stated

Primary outcomes

1

Description
Spiritual Health
Timepoint
Before the intervention and after the intervention
Method of measurement
Spiritual Health Questionnaire paloutzian & Ellison

Secondary outcomes

1

Description
Age, educational level, social class, income level, number of family members, the participation in religious ceremonies and rites
Timepoint
Before the intervention
Method of measurement
Demographic questionnaire

Intervention groups

1

Description
Intervention for spiritual counseling with Islamic approach individual whose 8 sessions for 45 to 60 minutes was performed at the patient's bedside.
Category
Other

2

Description
The control group received only care nurse at the hospital and did not receive counseling
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Educational Assistant Shahid Beheshti Hospital
Street address
Hamedan, Ghaem sqr,Shahid Beheshti Hospita.
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Street address
Arak University of Medical Sciences
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Naemeh Niazi
Position
MSc Student of Nursing
Other areas of specialty/work
Street address
Arak، Arak University of Medical Sciences
City
Arak
Postal code
6517817953
Phone
+98 81 3821 1670
Fax
Email
naemehniazi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Naemeh Niazi
Position
MSc Student of Nursing
Other areas of specialty/work
Street address
Arak University of Medical Sciences
City
Arak
Postal code
6517817953
Phone
+98 81 3821 1670
Fax
Email
naemehniazi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Naemeh Niazi
Position
MSc Student of Nursing
Other areas of specialty/work
Street address
Arak University of Medical Sciences
City
Arak
Postal code
6517817953
Phone
+98 81 3821 1670
Fax
Email
naemehniazi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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