Protocol summary

Summary
Breast cancer is a fatal disease that annually causes morbidity and mortality in hundreds of thousands of women worldwide and now a days breast cancer is the most important oppressive factor in women. Patients undergoing treatment for cancer face major physical and emotional challenges. Anxiety is common at the initiation of treatment, worrying of the potential side effects of the agents and fear of recurrence after completion of treatments. Spirituality can act as an effective source in contrast whit physical and mental responses to cancer. Spiritual and religious powers, such as prayer, play an important role in adaptation with diseases.so; this study was conducted to assess the influence of chosen prays on Sahifeh Sajadihe on stress and anxiety in patients under breast surgery in Baqiyatallah hospital. This study is a clinical trial whit two groups that was done in 2012 on 88 Patients referred to selected hospitals. Samples were randomly divided into two 44 patients groups. Group 1 was treated with the pray and group 2 as a control group. Data collection instruments were the questionnaire for recording personal data, and DASS questionnaire.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201204148290N3
Registration date: 2013-09-23, 1392/07/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-09-23, 1392/07/01
Registrant information
Name
Feryal Khamseh
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2228 9941
Email address
khamseh110@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baghiatallah University of Medical Sciences- School of Nursing- Behavior Sciences Research Center
Expected recruitment start date
2012-11-21, 1391/09/01
Expected recruitment end date
2013-03-15, 1391/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect plannedexploitaion of chosen pray of Sahife Sajadieh in reducing of stress and anxiety in breast cancer pations in selected hospital.
Public title
Evaluation of the effect of chosen pray of Sahife Sajadieh in reducing of stress and anxiety in breast cancer pations in selected hospital.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: the patients aged between 30 to 65 years old; breast cancer diagnosis; patients who need breast surgery; ability to hear. Exclusion criteria: patient whit psychologic disorder; patients whit endocrine disease like hypothyroid or hyper thyroid; the patients taking antianxiety and sedative drugs.
Age
From 30 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 88
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
Baghiatallah University of Medical Sciences
Street address
boulevar army-tee aghdasieh-baghiatallah nursing univercity
City
Tehran
Postal code
1956837173
Approval date
2012-06-11, 1391/03/22
Ethics committee reference number
384

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
Anxiety
Timepoint
Before intervention-after intervention-three days after intervention
Method of measurement
Spilberger trait inventory

2

Description
Stress
Timepoint
Before intervention-after intervention-three days after intervention
Method of measurement
Depression Anxiety and Depression Scale(DASS21)

Secondary outcomes

empty

Intervention groups

1

Description
Listening Prayer Scriptures Prayer Scriptures on Health hearing Sajjadiyeye
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiatollah hospital in Tehran
Full name of responsible person
feryal khamseh-MSc in Psychiatric
Street address
teHran - Mullasadra street - BMSU Hospital - Department of Surgery women
City
tehran

2

Recruitment center
Name of recruitment center
Mashhad-Omid hospital
Full name of responsible person
Saleheh ashoorinejad-Psychiatric graduate student
Street address
Mashhad-kohsangy street-omid hospital
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Dr. Jamileh Mokhtari
Street address
tehran - aghdasieh- araj - mojtama welayat
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Baqiyatallah 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
Baqiatollah University of Medical Sciences - School of Nursing
Full name of responsible person
saleheh ashoorinejad
Position
MSc in Psychiatric Nursing - Medical science
Other areas of specialty/work
Street address
Tehran - Aghdasieh. Araj -school of nursing- (Integrated Provincial)
City
tehran
Postal code
1956837173
Phone
+98 21 2228 9941
Fax
+98 21 2612 7237
Email
s_ashoorinejad@yahoo.com
Web page address
khamseh_110@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
BMSU University - School of Nursing
Full name of responsible person
feryal khamseh
Position
msc in Psychiatric-faculty member in baqiyatallah university
Other areas of specialty/work
Street address
tehran- Blvd Army - Aghdasieh - Araj - Nursing (Integrated Provincial)
City
tehran
Postal code
1956837173
Phone
+98 51 1878 4497
Fax
+98 21 2612 7237
Email
khamseh_11-@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University BMSU
Full name of responsible person
salehe ashoorinejad
Position
Psychiatric Postgraduate students
Other areas of specialty/work
Street address
Tehran - Blvd's army - Aghdasieh - Nursing (Integrated Provincial)
City
tehran
Postal code
1956837173
Phone
+98 51 1878 4497
Fax
+98 21 2612 7237
Email
s_ashoorinejad@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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