Protocol summary

Summary
The objective of this intervention study will be to determine the impact of group reflection in spiritual care on the spiritual health and nursing students' attitude. The participants of this study are the second year nursing students who tend to participate in this study. If they had attended in any educational courses of spiritual care or having been had for more than two sessions absence, they would have excluded from this study. The number of participants are 60 students who divided randomly into two groups, each group 30 students, of control & experimental groups. Before the beginning of intervention, students of both group will fill out attitude and spiritual health questionnaires. Students of experimental group attend in four reflecting sessions in which a suitable scenario raises to group discussion for each session. Students of control group attend in a two hours sessions in which spirituality discussions and spiritual care in form of lecture with educational media will be taught by the researcher of this study. Students of two groups fill out again questionnaires one month after the first session. The expected results of this study are the created changes in spiritual health and students' attitude to spirituality & spiritual care.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014050417546N2
Registration date: 2015-04-20, 1394/01/31
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-04-20, 1394/01/31
Registrant information
Name
Marzieh Momennasab
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4254
Email address
momennasab@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-11-01, 1393/08/10
Expected recruitment end date
2015-03-01, 1393/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of participation in spiritual groups on quality of life and empowerment in women with breast cancer - Shiraz Namazi hospital- 2014.
Public title
The effect of participation in spiritual groups on quality of life and empowerment in women with breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1. The age range of 18-60 years. 2. The willingness to participate in the study. 3. Having Reading and literacy. 4. Lack of chronic disease and other types of cancer. 5. Lack of mental illness. 6. Breast cancer as the first time and lack of cancer in other breast or any part of body. 7. Left behind the first meeting of chemotherapy and be in second meeting. 8. No evidence of metastatic breast cancer. 9. Lack of intense depression (got score less than 21 from the Beck questionnaire) exclusion criteria :1. The absence of two or more session from spiritual groups. 2. Withdrew from continue to cooperation in participate to research (investigation) in each stage of study. 3. The incidence of unexpected and sever physical or mental injuries.
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: 74
Randomization (investigator's opinion)
Randomized
Randomization description
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
shiraz University of Medical Sciences
Street address
shiraz-zand steet- shiraz University of Medical Sciences
City
shiraz
Postal code
71345-1978
Approval date
2014-10-11, 1393/07/19
Ethics committee reference number
93-7169

Health conditions studied

1

Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
quality of life
Timepoint
before and one month after intervention
Method of measurement
EORTC QLQ-C30 and EORTC QLQ-BR23 Questionnaire

2

Description
Empowerment
Timepoint
before and one month after intervention
Method of measurement
The Cancer Empowerment Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The experimental group will be divided into groups of 5-7 people, the experimental group 5 an hour once a week spiritual sessions will be held in two sessions. If the content of the sessions will be offered: Session I: Introduction and investigate the interplay of spirituality, spiritual practices and spiritual experiences, Session II: Religious behavior and its effects, Session III: What is the meaning and purpose, the fourth session: relationship with God and the saints of God and the fifth session of communication with others
Category
Other

2

Description
No intervention will conducted for control group.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Nemazi Hospital
Full name of responsible person
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor of research of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Basir Hashemi
Street address
Vice chancellor of research of Shiraz University of Medical Sciences, Namazi square
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research of Shiraz 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
Hazrate Fatemeh Nursing and Midwifery College
Full name of responsible person
Dr Marzieh Momennasab
Position
PhD in Nursing, Associated professor
Other areas of specialty/work
Street address
Hazrate Fatemeh Nursing and Midwifery College, Namazi Square, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
momennasab@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hazrate Fatemeh Nursing and Midwifery College
Full name of responsible person
Marzieh Momennasab
Position
PhD in Nursing, Associated professor
Other areas of specialty/work
Street address
Hazrate Fatemeh Nursing and Midwifery College, Namazi Square, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3647 4254
Fax
Email
momennasab@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hazrate Fatemeh Nursing and Midwifery College
Full name of responsible person
Marzieh Momennasab
Position
PhD in Nursing
Other areas of specialty/work
Street address
Hazrate Fatemeh Nursing and Midwifery College, Namazi Square, Shiraz
City
Postal code
Phone
+98 71 3647 4254
Fax
Email
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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