Protocol summary

Summary
Abstract: The main goal: Determine the effect of Benson relaxation technique on quality of life in breast cancer patients undergoing chemotherapy Design: In this study, 25 patients were breast cancer undergoing chemotherapy regimen (Taksvtr, Dryamaysyn, cyclophosphamide) TAC : 3 times the total units in the study filled out questionnaires. Finally, the results were analyzed by SPSS software. The main goal:Determine the effect of Benson relaxation technique on quality of life in breast cancer patients undergoing chemotherapy. Design: In this study, 25 patients suffering from breast cancer undergoing chemotherapy regimen (Taksvtr, Dryamaysyn, cyclophosphamide) TAC; the total units in the study filled out questionnaires 3 times. Inclusion criteria: willing to participate in research; ability to answer questions; have a chemotherapy regimen used for samples; being familiar with Persian language; primary breast cancer; age between 25-50 years old; not having a history of mental illness; between second to fourth courses of chemotherapy; unilateral mastectomy surgery and not having other chronic disease. Exclusion criteria: participate in counseling and educational programs at the second intervention; radiotherapy concurrently with chemotherapy; risk of psychosis and the use of psychoactive drugs and no clinical signs of metastasis to other body parts. Interventions: relaxation of Benson. The main outcome variables: Quality of life Interventions: Relaxation of Benson The main outcome variables: Quality of life

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201204229537N1
Registration date: 2012-05-21, 1391/03/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-05-21, 1391/03/01
Registrant information
Name
Masoome Salehi Kamboo
Name of organization / entity
Ahwaz Universit of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1444 9672
Email address
salehi-m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz University of Medical Sciences
Expected recruitment start date
2009-03-18, 1387/12/28
Expected recruitment end date
2009-05-31, 1388/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Survey Effect Of Benson Relaxation On Quality Of Life In Breast Cancer Patients Under Going Chemotherapy
Public title
Effect Of Benson Relaxation On Breast Cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: willing to participate in research; ability to answer questions; have a chemotherapy regimen used for samples; being familiar with Persian language; primary breast cancer; age between 25-50 years old; not having a history of mental illness; between second to fourth courses of chemotherapy; unilateral mastectomy surgery and not having other chronic disease. Exclusion criteria: participate in counseling and educational programs at the second intervention; radiotherapy concurrently with chemotherapy; risk of psychosis and the use of psychoactive drugs and no clinical signs of metastasis to other body parts.
Age
From 25 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahvaz University of Medical Sciences
Street address
Bolvare golestan-Ahwaz University of Medical Science-ahvazا
City
Ahvaz
Postal code
6163735179
Approval date
2008-12-30, 1387/10/10
Ethics committee reference number
1398

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
3 week
Method of measurement
C30-BR23 quality of life questionnare

Secondary outcomes

1

Description
Symptom scales and functional scales
Timepoint
3 weeks
Method of measurement
C-30 and BR23 QOL questionairs

Intervention groups

1

Description
Intervention: Benson relaxation to breast cancer patients by tape and they listen to tape for 3 weeks; ( during this time the researcher speak to patients by telephone and followed the patients) the quality of life questionnaire were filled.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz University of Medical Sciences
Full name of responsible person
Masoome Salehi Kamboo
Street address
Bolvare golestan-Ahvaz medical university-ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Mostafa Feghhi
Street address
Bolvare golestan- Ahvaz University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Masoome Salehi Kamboo
Position
Master of nursing
Other areas of specialty/work
Street address
Bolvare golestan-Ahvaz medical university-ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1444 9672
Fax
Email
masoome_salehi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Masoome Salehi Kamboo
Position
Master of nursing
Other areas of specialty/work
Street address
Bolvare golestan- Ahvaz medical university-Ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1444 9672
Fax
Email
Masoome_salehi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Masoome Salehi Kamboo
Position
Master of nursing
Other areas of specialty/work
Street address
Bolvare golestan- Ahvaz medical university-ahvaz
City
Ahvaz
Postal code
Phone
+98 61 1444 9672
Fax
Email
Masoome_salehi@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
Loading...