Determination of the effect of massage therapy on the comfort and ease of chemotherapy cancer patients
Design
Preset investigation is designed as clinical trial with pretest and posttest with separated groups as well as computer randomized selection of 50 persons so that in the list, ones having odd numbers were selected as controls and those with even number were selected as the members of intervention group.
Settings and conduct
As research aimed to check impact of massage on cancer patients, thus the intervention group received massage therapy in ten sessions of forty-five minutes, and the questionnaire was filled once before starting the session and once at the end of last massage session. It was conducted in Bu-Ali hospital in Tehran and no blinding was done.
Participants/Inclusion and exclusion criteria
Inclusion criteria: aged 18 and over, not being placed in the final stage of the disease, receiving at least 3 sessions of chemotherapy
Exclusion criteria: Placing in the final stage, more than one absentee session in the massage session
Intervention groups
Group One includes eligible cancer patients receiving massage therapy
Group two includes eligible cancer patients not receiving massage therapy
Main outcome variables
One of the variables is the symptoms that include the related signs and symptoms and the other one is comfor
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180803040680N1
Registration date:2020-03-15, 1398/12/25
Registration timing:retrospective
Last update:2020-03-15, 1398/12/25
Update count:0
Registration date
2020-03-15, 1398/12/25
Registrant information
Name
narges mardaneh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3360 3970
Email address
seo.sami1990@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-15, 1396/10/25
Expected recruitment end date
2018-07-03, 1397/04/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of massage therapy on the comfort and ease of cancer patients under chemotherapy
Public title
The effect of massage on cancer symptoms reduction
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 and above
Reception of at least 3 chemotherapy sessions
Exclusion criteria:
The onset of severe metastatic complications or physical and mental health problems affecting the intervention
Unwillingness of the selected patient to collaborate after sampling
Age
From 27 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Permuted block randomization
Randomization unit: Blocks (5 persons)
Lack of using stratified randomization
Randomization tools: In this study, the block randomization approach was used. The 5-person blocks were used and the samples were divided into 5-person groups (blocks) based on the inclusion criteria. Selected blocks were consecutively considered as an intervention and control group. It did so that the first block was considered as the intervention and the second block as control and continued until the sampling was completed.
Random sequence generation: The sequence generation method in this study was restricted randomization. Permuted block randomization was used among the restricted randomization methods.
Allocation concealment: The blocks assigned to the intervention and control groups were made without the participants' knowledge and they were not aware of how the groups were assigned. Sequentially numbered, sealed, opaque envelopes were used to record information about the random sequence created, with the number assigned to the members of each block and the envelopes arranged according to the exact sequence to be used at the start of the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Islamic Azad University Ethical Commitee
Street address
No. 4- Dead End 5 -Ravanbakhsh St - Toos Street-Kian Shahr - Tehran
City
Tehran
Province
Tehran
Postal code
1853794939
Approval date
2018-03-11, 1396/12/20
Ethics committee reference number
IR.IAU.TMU.REC.1396.132
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
D70.1
ICD-10 code description
Agranulocytosis secondary to cancer chemotherapy
Primary outcomes
1
Description
The effect of massage therapy on the feeling of comfort
Timepoint
Once at the beginning and once the end of the intervention
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
This study examines the impact of massage therapy on cancer patients. The intervention group included patients with cancer who received massage therapy in 10 sessions for 45 minutes in addition to receiving routine treatments.
Category
Other
2
Description
In this study, the control group included cancer patients who received only their routine medicines (routine care, no massage, and no extra work).