Protocol summary
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Study aim
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Effects of benson's muscle relaxation on quality of sleep and anorexia of cancer patients
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Design
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Clinical trial with control group, with parallel groups, without blindness, randomized
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Sleep quality؛ Anorexia
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20130424013110N5
Registration date:
2019-01-31, 1397/11/11
Registration timing:
prospective
Last update:
2019-08-25, 1398/06/03
Update count:
1
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Registration date
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2019-01-31, 1397/11/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-02-19, 1397/11/30
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Expected recruitment end date
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2019-06-22, 1398/04/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effect of benson muscle relaxation on cancer patients’s quality of sleep & anorexia: a randomized clinical trial
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Public title
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The effect of benson muscle relaxation on quality of sleep & anorexia
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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From 30 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-12-16, 1397/09/25
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Ethics committee reference number
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IR.ARAKMU.REC.1397.247
Health conditions studied
1
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Description of health condition studied
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Cancer
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ICD-10 code
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C80.0
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ICD-10 code description
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Disseminated malignant neoplasm, unspecified
Primary outcomes
1
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Description
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Sleep Quality
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Timepoint
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Before and 5 days after the intervention
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Method of measurement
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SMHSQ Sleep Quality Questionnaire
2
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Description
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Anorexia
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Timepoint
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30 minute before chemotherapy, Immediately after chemotherapy, 24 hour after intervention, 48 hour after intervention.
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Method of measurement
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Anorexia questionnaire with Visual Analog Scale (VAS)
Intervention groups
1
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Description
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Intervention group: Benson muscle relaxation for five days and every day for 20 minutes will be performed by the intervention group
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Category
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N/A
2
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Description
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Control group: This group only will receive their routine cares and cures.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Arak University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available