Effects of benson's muscle relaxation on quality of sleep and anorexia of cancer patients
Design
Clinical trial with control group, with parallel groups, without blindness, randomized
Settings and conduct
In this study will be selected 80 patients suffering from cancer hospitalized in the hematology and oncology departments of Ayatollah Khansari hospital in arak city and with random blocks will be divided to two groups of experimental and control. Benson muscle relaxation for five days and every day for 20 minutes will be performed by the intervention group, control group during this period only will receive their routine cares and cures.The questionnaires before and after 5 days will be completed for both groups.
Participants/Inclusion and 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. Exclusion criteria: a) Lack of Literacy; b) Non-treatable cancer.
Intervention groups
Intervention group: In this group benson muscle relaxation for five days and every day for 20 minutes will be performed by the patients.
Control group: This group only will receive their routine cares and cures.
Main outcome variables
Sleep quality؛ Anorexia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130424013110N5
Registration date:2019-01-31, 1397/11/11
Registration timing:prospective
Last update:2019-01-31, 1397/11/11
Update count:1
Registration date
2019-01-31, 1397/11/11
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
Expected recruitment start date
2019-02-19, 1397/11/30
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of benson muscle relaxation on cancer patients’s quality of sleep & anorexia: a randomized clinical trial
Public title
The effect of benson muscle relaxation on quality of sleep & anorexia
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age between30-60 years old
Experience of at least one period of chemotherapy
Absence of psychologic or known cognitive disease
Stages 2,3 & 4 of cancer
Exclusion criteria:
Lack of literacy
Non-treatable cancer
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In order to allocate the patients randomly into two groups of treatment and control, at first 8 blocks of 10 with C and T letters (The letters indicate the intervention and control groups) are created in each 5 patients are belonged to the intervention group and 5 patients are belonged to the control group). Then the blocks are randomly selected and arranged to obtain a sequential combination of 80 letters. Each letter will be placed in a sealed packet according to the obtained sequence.
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
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
Province
Markazi
Postal code
38481-76941
Approval date
2018-12-16, 1397/09/25
Ethics committee reference number
IR.ARAKMU.REC.1397.247
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
C80.0
ICD-10 code description
Disseminated malignant neoplasm, unspecified
Primary outcomes
1
Description
Sleep Quality
Timepoint
Before and 5 days after the intervention
Method of measurement
SMHSQ Sleep Quality Questionnaire
2
Description
Anorexia
Timepoint
Before and 5 days after the intervention
Method of measurement
Anorexia questionnaire with Visual Analog Scale (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Benson muscle relaxation for five days and every day for 20 minutes will be performed by the intervention group
Category
N/A
2
Description
Control group: This group only will receive their routine cares and cures.
Category
N/A
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
Province
Markazi
Postal code
38149 - 5 - 7558
Phone
+98 86 3367 5001
Email
m.harorani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad arjomandzadegan
Street address
Vice Chancellery For Research And Education, Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
38481-76941
Phone
+98 86 3417 3503
Email
m.harorani@yahoo.com
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Harorani
Position
Academic Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
38481-76941
Phone
+98 86 3417 3503
Email
m.harorani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Harorani
Position
Academic Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
38481-76941
Phone
+98 86 3417 3503
Email
m.harorani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mehdi Harorani
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
38481-76941
Phone
+98 86 3417 3503
Email
m.harorani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available