Evaluation of the effectiveness of Shiatsu massage on physiological index, anxiety and pain during chemotherapy in patients with breast cancer
Design
Clinical trial with control group, with parallel groups, Single blinded, randomized
Settings and conduct
In this study, 72 patients with breast cancer undergoing chemotherapy hospitalized in Ayatollah Khansari hospital in Arak city were selected and with random blocks will be divided to two groups of experimental and control. Alternate shiatsu will be performed for 5 minutes massage and 2-minute rest to 20 minutes by the intervention group, control group during this period will receive touch without pressure for 20 minutes.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Cancer patients who have undergone at least one course of chemotherapy; age more than 18 and under 60, diagnosed with stage 2, 3, and 4 cancers at the discretion of the relevant physician; cancer patients with 6 months from the date of diagnosis exclusion criteria: Any life-threatening emergency situation ;skin diseases such as ulcers and infections of hand
Intervention groups
For the intervention group, during chemotherapy, a one-time Shiatso massage will be performed on the Hugo spots for 5 minutes and 2 minutes of rest for up to 20 minutes. In the control group during chemotherapy, patients do not receive any intervention from the researcher for Shiatsu massage. In this group, only a touch without pressure will be performed for 20 minutes. The amount of pain, anxiety and physiological signs will be measured before and immediately after the intervention by tools and questionnaires.
Main outcome variables
Anxiety rate; Pain rate; Number of breaths;Blood pressure; Heart rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151002024290N2
Registration date:2020-05-25, 1399/03/05
Registration timing:prospective
Last update:2020-05-25, 1399/03/05
Update count:0
Registration date
2020-05-25, 1399/03/05
Registrant information
Name
Zohreh Farahani
Name of organization / entity
Arak Medical University
Country
Iran (Islamic Republic of)
Phone
+98 86 3497 2718
Email address
z.farahani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Shiatsu massage on physiological parameters ,anxiety and pain during chemotherapy in patients with breast cancer
Public title
The effect of Shiatsu massage in patients with breast cancer under chemotherapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Cancer patients who have been undergoing chemotherapy for at least one period.
Age more than 18 and less than 60 years.
Diagnosis of stages 2, 3 and 4 of cancer According to the relevant physician.
Cancer patients with 6 months of diagnosis
Full of consciousness
No history of mental illness, seizures or epilepsy, asthma, thyroid disorder, olfactory disorder, severe heart failure that has been approved by a doctor
No history of smoking and drug addiction
Under chemotherapy with a special protocol
Exclusion criteria:
Paralysis of the hands
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting the samples by random sampling method, they will be randomly and according to the table of random numbers in the two groups of test and control. In order to randomize the selection of 72 patients into two intervention and control groups, first 9 different blocks of 8 letters T and C are created, which indicate the intervention and control groups (4 people belonging to the intervention group and 4 people). Belong to the control group. These blocks are then randomly selected by drawing lots to obtain a 72-bit combination of blocks, respectively. The resulting combination of letters is placed one by one in 72 closed envelopes, respectively, and with the visit of each patient, one envelope is opened in order to determine in which group the patient is placed.
Blinding (investigator's opinion)
Single blinded
Blinding description
It should be noted that the nurse who will measure vital signs and the level of anxiety and pain of the patient through the Spielberger questionnaire tool and the visual scale of pain will be unaware of the type of intervention being performed
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 sciencese
Street address
Arak, Basij Square, Campus University of Medical Sciences Campus, School of Nursing
City
Arak
Province
Markazi
Postal code
3848176341
Approval date
2019-08-06, 1398/05/15
Ethics committee reference number
IR.ARAKMU.REC.1398.091
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Anxiety
Timepoint
Measure the amount of anxiety before each chemotherapy treatment with the intervention and immediately after each chemotherapy treatment with the intervention.
Method of measurement
Spielberger Questionnaire
2
Description
Pain
Timepoint
Measure the amount of pain before each chemotherapy treatment with the intervention and immediately after each chemotherapy treatment with the intervention.
Method of measurement
Visual analog scale
3
Description
Blood pressure
Timepoint
Measure the amount of blood pressure before each chemotherapy treatment with the intervention and immediately after each chemotherapy treatment with the intervention
Method of measurement
Mercury blood pressure device
4
Description
Number of heartbeats
Timepoint
Measure the amount of number of heartbeats before each chemotherapy treatment with the intervention and immediately after each chemotherapy treatment with the intervention
Method of measurement
Cardiac and pulmonary monitor device
5
Description
Number of breaths
Timepoint
Measure the amount of number of breaths before each chemotherapy treatment with the intervention and immediately after each chemotherapy treatment with the intervention
Method of measurement
Cardiac and pulmonary monitor device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:For the intervention group, during chemotherapy, a one-time Shiatso massage will be performed on the Hugo spots for 5 minutes and 2 minutes of rest for up to 20 minutes. The amount of pain, anxiety and physiological signs will be measured before and immediately after the intervention by tools and questionnaires.
Category
N/A
2
Description
Control group: Patients in the control group do not receive any Shiatsu massage intervention on the part of the researcher. In this group, only touch without pressure will be done for 20 minutes.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Khansari Hospital
Full name of responsible person
Zohreh Farahani
Street address
University street
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
z.farahani@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Alireza Kamali
Street address
Vice Chancellery For Research And Education, Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3503
Email
research@arakmu.ac.ir
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
Zohreh Farahani
Position
Academic Instructor Faculty Of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School Of Nursing, Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3503
Email
z.farahani@arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Zohreh Farahani
Position
Academic Instructor Faculty Of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School Of Nursing, Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3503
Email
z.f.h.nursing@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Zohreh Farahani
Position
Academic Instructor Faculty Of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School Of Nursing, Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3503
Email
z.f.h.nursing@gmail.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