Objectives: effects of relaxation methods on self-efficacy and self-esteem of cancer patients. Design: 80 of cancer patients will be selected for samples available and by using a randomized complete block will be divided in to intervention and control group. Setting and conduct: the patients with following criteria will be enrolled into the study; a) age between30-60 years old; b) experience of at least one period of chemotherapy; c) absence of psychologic or known cognitive disease; d) stages 2,3 & 4 of cancer. Intervention 1: For the intervention group initially pre-test questionnaire will be completed. Then educational content will be presented during the two sessions of 30 minutes at a distance of a day of each other and the patients this technique will applied for 60 days. The curriculum includes providing a quiet environment and education tighten and relax muscles from head to toe or vice versa will be accompanied by deep breathing. The questionnaires after 60 days will be completed for this group, again. Intervention 2: For the control group initially pre-test questionnaire will be completed. While during this period control group only will receive their routine cares and cures, the questionnaires after 60 days will be completed for this group, again. Main outcome measures: Self-efficacy by strategies used by patients to promote health questionnaire and Self-esteem by cooper smith questionnaire will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015070113110N2
Registration date:2015-09-08, 1394/06/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-08, 1394/06/17
Registrant information
Name
Mehdi Harorani
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
m.harorany@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor of Education and Research Arak University of Medical Sciences.
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-10-23, 1394/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation on the effectiveness relaxation methods on self-efficacy and self-esteem of cancer patients: a randomized clinical trial.
Public title
Investigation on the effectiveness relaxation methods on self-efficacy and self-esteem of cancer patients.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:a) age between30-60 years old; b) being chemotherapy for at least one period; c) stages 2,3 or 4 of cancer; d) absence of psychologic or known cognitive disease.
Exclusion criteria: a) Lack of patient cooperation during the intervention for any reason; b) complete faulty of questionnaires.
Age
From 30 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be by using random blocks.
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Vice Chancellery For Research And Education, Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Postal code
38481-76941
Approval date
2015-07-11, 1394/04/20
Ethics committee reference number
IR.ARAKMU.REC.1394,79
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
C80.9
ICD-10 code description
Malignant neoplasm, unspecified
Primary outcomes
1
Description
Self-Efficacy
Timepoint
Before and 60 days after the intervention.
Method of measurement
Self-Efficacy questionnaire Strategies Used by Patients to Promote Health
2
Description
Self-Esteem
Timepoint
Before and 60 days after the intervention.
Method of measurement
Self-Esteem questionnaire Cooper Smith
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: The cancer patient's self-efficacy scale and self-esteem questionnaire will be completed at the beginning of the study. The content of educational will be presented during the two sessions of 30 minutes at a distance of a day of each other. Then the patients this technique will applied for 60 days. The questionnaires after 60 days will be completed in this group, again.
Category
Treatment - Other
2
Description
Control group: The cancer patient's self-efficacy scale and self-esteem questionnaire will be completed at the beginning of the study. This group only will receive their routine cares and cures. The questionnaires after 60 days will be completed in this group, again.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Khansari hospital, Arak
Full name of responsible person
Mehdi Harorani
Street address
Daneshgah Avenue
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor of Education and Research Arak University of Medical Sciences
Full name of responsible person
Dr. Ali Ghazavi
Street address
Vice Chancellery For Research And Education, Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor of Education and Research 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
Mehdi Harorani
Position
Master of Science in Nursing
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr Square, Arak
City
Arak
Postal code
38149 - 5 - 7558
Phone
+98 86 3222 2003
Fax
-
Email
m.harorani@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
Mehdi Harorani
Position
Master of Science in Nursing
Other areas of specialty/work
Street address
Valiasr Hospital, Valieasr Square, Arak
City
Arak
Postal code
38149 - 5 - 7558
Phone
+98 86 3222 2003
Fax
Email
m.harorani@yahoo.com; m.harorani@gmaile.com
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Valiasr Hospital Arak
Full name of responsible person
Mehdi Harorani
Position
Master of Science in Nursing
Other areas of specialty/work
Street address
Valiasr Hospital, Valiasr Square, Arak
City
Arak
Postal code
-
Phone
+98 86 3222 2003
Fax
Email
m.harorani@yahoo.com; m.harorani@gmaile.com
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)