Objectives: The aim of this study is to determine the effect of slow stroke back massages (SSBM) on ‘anxiety’ among older woman patients with breast cancer undergoing chemotherapy.
design: Experimental phase 2 clinical trial with a control group.
Study population: Elderly women patients with breast cancer underwent chemotherapy regimens, those who admited to oncology ward of Firouzgar and Hazrate Rasoul Hospitals.
Main inclusion criteria: Those who have no cognitive impairment regarding to AMT. Those who have at least 60 years of age or older. Those who received at least one chemotherapy session before the intervention.Those who have breast cancer in stages I, II and III. Main exclusion criteria: Those who Disaffiliate or death. Those who taking anti-anxiety drugs, anticoagulants, corticosteroids and narcotics. Those who Discharge before three days of admission due to the chemotheapy.
Sample size: 84
Main outcome measures: Anxiety
Intervention method: After fulfilment pre-tests (filling the demographic data form and geriatric anxiety scale (GAS)), the study group will be undergo slow strocke back massage for three consecutive days and for about 15 min per day that performed by a massage therapy licensed nurse. At the end of third day intervention, all participants completed the Geriatric Anxiety Scale (GAS) again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015082223713N1
Registration date:2015-10-14, 1394/07/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-14, 1394/07/22
Registrant information
Name
Massoumeh Basiri
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 13 3455 4754
Email address
basiri.m@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of the slow stroke back massage (SSBM) on ‘anxiety’ among older woman with breast cancer undergoing chemotherapy
Public title
Effect of massage therapy on anxiety among patients with breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Those who have no cognitive impairment regarding to AMT; Those who have at least 60 years of age or older; Those who received at least one chemotherapy session before the intervention; Those who have no severe respiratory secretions caused by lung diseases; Those who not taking anti-anxiety drugs, Anticoagulants, corticosteroids and narcotics; Those who have breast cancer in stages I, II and III; Those who have no speech and hearing problem so that the data collection forms could be clearly filled in through face to face talks with the patient or on the telephone; Those who have no bed rest; Those who have no complications of skin and bone in the neck, back and sacrum; Those who have no spinal tumors.
Exclusion criteria:
Those who Disaffiliate or death; Those who taking anti-anxiety drugs, anticoagulants, corticosteroids and narcotics; Those who change their treatment from chemotherapy to Hormone Therapy and cytostatics; Those who Discharge before three days of admission due to the chemotheapy.
Age
From 60 years old to 80 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study, sampling will be carried out using sequential (targeted) method. So that the patients those who have the inclusion criterias, will dispart into the intervention and control groups randomly by utlizing coin toss method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of the Iran University of Medical Science
Street address
Between the intersection of sheikh fazlolahe nouri st. and shahid chamran st., Toward the west of Shahid Hemmat Highway, Iran University of Medical Science, Tehran, Iran
City
Tehran
Postal code
Approval date
2015-07-20, 1394/04/29
Ethics committee reference number
IR.IUMS.REC.1394.9211580204
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
Before and immediately after of intervation
Method of measurement
Geriatric Anxiety Scale (GAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Applying slow Stroke Back Massage (SSBM) for three 15'' sessions in three consecutive days
Category
Other
2
Description
Control group: Does not receive any specific intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrate Rasoul educational-medical center related to IUMS
Full name of responsible person
Massumeh Basiri
Street address
Hazrate Rasoul educational-medical center, At the corner of the Mansouri St, Niayesh St, Sattarkhan district, Urban area 2, Tehran, Iran
City
Tehran
2
Recruitment center
Name of recruitment center
Firouzgar educational-medical center related to IUMS
Full name of responsible person
Massumeh Basiri
Street address
Firouzgar educational-medical center, Karimkhan zand St. to Beh-Afarin St., Vali Asr Square, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research- Iran University of Medical Science
Full name of responsible person
Dr Seyed Ali Javad Mousavi
Street address
The fifth floor of headquarters,Iran University of Medical Science, Between the intersection of sheikh fazlolahe nouri st. and shahid chamran st., Toward the west of Shahid Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research- Iran University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Nursing and Midwifery, Iran University of Medical Science
Full name of responsible person
Massoumeh Basiri
Position
Student / M.Sc.
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Iran University of Medical Science, Rashid Yasemi St., ahead of the Vanak square, Vali-Asr St.