This research is RCT, contain 3 groups, control, interventional, placebo research. The purpose of this study was to investigating effect of therapeutic touch plane on nausea and vomitting induced by chemotherapy. Sampling was intentional with random allocation in to groups. Inclusion criteria: age between 18- 55 years old; with or without metastasis(except digestive and central nervous system metastasis); same medicine regiment in 3 groups; experience of at least one course chemotherapy & nausea induced chemotherapy.
Exclusion criterion: unsatisfaction for participating in research; acute condition for patients such that cant continue participating in research.
Intervention were implementing therapeutic touch, with same medicine regiment in three groups to reduce nausea and vomitting. major variations were nausea in duration, intensity,times dimention and vomitting by intensity dimention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013080311136N2
Registration date:2013-08-28, 1392/06/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-28, 1392/06/06
Registrant information
Name
pegah Matoury
Name of organization / entity
Tarbat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 31 2524 5616
Email address
pegah.matoury@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Tarbiat Modares University
Expected recruitment start date
2013-01-19, 1391/10/30
Expected recruitment end date
2013-06-21, 1392/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Therapeutic Touch plan on nausea and vomitting in breast cancer women who receiving chemotherapy
Public title
Effect of Therapeutic Touch on nausea and vomitting in breast cancer women who receiving chemotherapy
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria: age between 18- 55 years old; with or without metastasis(except digestive and central nervous system metastasis); same medicine regiment in 3 groups; experience of at least one course chemotherapy & nausea induced chemotherapy.
Exclusion criterion: unsatisfaction participating in research; acute condition for patients such that cant continue participating in research.
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tarbiat modares university
Street address
Gisha pole, Jalale Ale Ahmad Free way
City
tehran
Postal code
Approval date
2012-10-24, 1391/08/03
Ethics committee reference number
52/2510د
Health conditions studied
1
Description of health condition studied
Breast caner
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Nausea
Timepoint
Befoe & After intervention
Method of measurement
Check list, VAS
2
Description
Vomit
Timepoint
Befor and after intervention
Method of measurement
Check list, VAS(visual analoge scale)
Secondary outcomes
1
Description
Onset of nausea after intervention
Timepoint
After intervention
Method of measurement
Check list
Intervention groups
1
Description
Implementation of therapeutic touch before recieving chemotherapy
Category
Treatment - Other
2
Description
Recivieng chemotherapy and antiemetic drugs
(routine care)
Category
Treatment - Other
3
Description
Implementation mimic therapeutic touch before chemotherapy but not up to down, hands hold far from patients body. This do to unification plasebo and intervention group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Seied Alshohada hospital
Full name of responsible person
Street address
City
Isfshan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat modares university
Full name of responsible person
Seied Saeed Mosavian
Street address
Room number 121, First floor, Medical Science Faculty, Tarbiat Modares University,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat modares university
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
Tarbit Modares University
Full name of responsible person
Pegah Matory
Position
MSc student of nursing
Other areas of specialty/work
Street address
Gisha pole- Jalale Ale Ahmad free way
City
Tehran
Postal code
Phone
+98 31 2524 5616
Fax
Email
pegah.matoury@modares.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Pegah Matory
Position
MSc student of nursing
Other areas of specialty/work
Street address
Gisha pole- Jalale ale ahmad- Free way
City
Tehran
Postal code
Phone
+98 21 8288 3856
Fax
Email
pegah.matoury@modares.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Pegah Matoury
Position
MSc student
Other areas of specialty/work
Street address
Gisha pole- Jalale Ale Ahmad
City
Tehran
Postal code
Phone
+98 31 2524 5616
Fax
Email
pegah.matoury@modares.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)