Protocol summary
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Study aim
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The comparison of foot reflexology massage with placebo on fatigue, pain intensity and sleep quality in lymphoma patients referring to Shiraz University of Medical Sciences
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Design
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A clinical trial with control group, parallel group randomized trial and single blinded
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Settings and conduct
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the settings of the study would be all Hematology and Oncology wards in Namazi and Amir Hospital affiliated to Shiraz University of Medical Sciences. In this study, a person who collects the outcomes of the study, as well as a statistician and health care provider, will be blind until the end of the study and completion of the data analysis and reporting.
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Participants/Inclusion and exclusion criteria
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The inclusion criteria were lymphoma patients with 18 years old or above, and speak Persian language. The patients with infectious or bleeding ulcer in their legs, inability to tolerate foot reflexology massage; physical disability, or known case of psychiatric disorder that are disable to perform self-care; and the use of sleep medications would be excluded.
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Intervention groups
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The patient lays on a bed in a quiet environment. The massage therapist places at the below of the patient's bed and each foot receives a reflective massage for 15 minutes. Firstly, the sweet almond oil is used. Then, the following points would be massaged for five consecutive days: the sleep points consisted of the thumb and Solar Plexus. Moreover, the inner edge, soles and heel to the ankle of the foot which relate to the fatigue and pain of the spine, the scapula, the hands, and the legs, would be massaged. Patients in the control group do not receive any type of massage during these 5 days and receive the same care that is provided to the intervention group.
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Main outcome variables
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fatigue; pain intensity; sleep quality
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:
IRCT20130616013690N6
Registration date:
2018-09-28, 1397/07/06
Registration timing:
prospective
Last update:
2019-01-24, 1397/11/04
Update count:
1
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Registration date
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2018-09-28, 1397/07/06
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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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2018-09-29, 1397/07/07
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Expected recruitment end date
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2018-12-28, 1397/10/07
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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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comparison of the foot reflexology massage with placebo on fatigue, pain intensity and sleep quality in patients with lymphoma referring to Shiraz University of Medical Sciences: a clinical trial study
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Public title
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Effect of foot reflexology massage on lymphoma patients
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Diagnosis of lymphoma according to patient records
Patients with 18 years old or above
be able to understand and speak in Persian language
Interested in participating in the study
Exclusion criteria:
Infectious or bleeding ulcers in the legs
Intolerance of reflective massage
Physical disability or known mental disorder that disable the patient in self-care
The use of sleep medications
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Age
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From 18 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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- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
62
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Firstly, the patients are included in the study using convenience sampling. Then, a random block with four block is used to randomly assign patients into the both groups. Block list is provided by the "Create a block randomization list" software. Each block is then placed inside a envelope and numbered. In this way, after selecting a patient, a numbered envelope is opened, the patient is allocated into the intervention or control groups based on the contents of envelope.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In this study, the person who evaluates the outcome, the healthcare staff , and the statistician would be remained blind into the groups. For this purpose, all of the above individuals would be blind into the groups until the analysis of the data is complete and reported.
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Placebo
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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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2018-06-20, 1397/03/30
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Ethics committee reference number
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IR.SUMS.REC.1397.267
Health conditions studied
1
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Description of health condition studied
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Hodgkin lymphoma
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ICD-10 code
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C81
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ICD-10 code description
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Hodgkin lymphoma
2
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Description of health condition studied
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Non-Hodgkin lymphoma
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ICD-10 code
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C85.9
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ICD-10 code description
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Non-Hodgkin lymphoma, unspecified
Primary outcomes
1
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Description
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Fatigue
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Timepoint
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Before the intervention and fifth days of the intervention
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Method of measurement
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Multidimensional Fatigue Inventory
Secondary outcomes
1
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Description
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Pain intensity
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Timepoint
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Before the intervention and fifth days of the intervention
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Method of measurement
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numerical pain scale
2
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Description
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sleep quality
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Timepoint
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Before the intervention and fifth days of the intervention
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Method of measurement
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Petersburg Sleep Questionnaire
Intervention groups
1
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Description
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Intervention group: The patient lays on a bed in a quiet environment. The massage therapist places at the below of the patient's foot and each foot receives a reflective massage for 15 minutes. Massage will be done in five consecutive days at 4 pm. In order to do massage, firstly, the sweet almond oil is used. Then the foot thumb and Solar Plexus which are related to sleep receive massage. Moreover, the inner edge, solar, and heel to the ankle of the foot, which are related to fatigue and back, scapula, hands and feet pain are given massage for five consecutive days.
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Category
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Rehabilitation
2
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Description
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Control group: The control group does not receive any type of massage. This group receives routine care such as the intervention group.
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Category
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Placebo
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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Shiraz 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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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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main outcome
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When the data will become available and for how long
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2020
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To whom data/document is available
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University institutes
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Under which criteria data/document could be used
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The data can only be accessed by the journal that want to publish the article and no further use is permitted.
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From where data/document is obtainable
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In order to access to the data, contact to Email: rambodma@yahoo.com
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What processes are involved for a request to access data/document
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In order to access to the data, contact to Email: rambodma@yahoo.com
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Comments
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