This study was conducted to evaluate the effect of music therapy and semi-fowler position on nausea and vomiting in women with breast cancer of 20-60 years. 90 patients who had study criteria’s (having a 6-session treatment regimen every 21 days; start the first course of chemotherapy) were divided into 3 groups by using simple random method. The first group involved Music therapy group listened through headphones to own favorite music. Patients in semi-fowler position with an angle of 60-45 degrees, treated with chemotherapy. And the third group of patients did not receive any intervention. During these 24 hours, researchers recorded all information such as measure of the severity of nausea on a visual analogue scale of the patient was marked. To determine frequency of vomiting, using four criteria that range between 0 to 3 is the were determined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203086918N4
Registration date:2012-09-14, 1391/06/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-09-14, 1391/06/24
Registrant information
Name
Alehe Seyedrasooli
Name of organization / entity
Faculty of Nursing & Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 0365
Email address
seyyedrasooly@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for research, Tabriz University of Medical Sciences
Expected recruitment start date
2011-05-05, 1390/02/15
Expected recruitment end date
2012-05-09, 1391/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of music therapy and semi-fowler position on nausea and vomiting in women with breast cancer
Public title
The effect of music and position on nausea and vomiting
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Women with breast cancer(grade 1,2,3; Having a 6-session treatment regimen every 21 days; Start the first course of chemotherapy; Having 20-60 years of age; Having read and write; Lack of vision problems; Not having trouble hearing; Select the protocol of chemotherapy that causes nausea and vomiting; Half hour before receiving chemotherapy as an anti-nausea medication
Exclusion criteria: History of previous gastric problems ; Metastases detected at any stage of treatment ; In the absence of blood factors in the range of normal blood factors will increase the time to ; Lack of patient cooperation to continue; No fill the time of study
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Medical Sciences
Street address
Faculty of Nursing & Midwifery of Tabriz; Iran
City
Tabriz
Postal code
34751745
Approval date
2012-01-02, 1390/10/12
Ethics committee reference number
9083
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
Z00-Z99
ICD-10 code description
Malignant Neoplasm of Breast
Primary outcomes
1
Description
Nausea
Timepoint
8,16,24 hour after Procedure
Method of measurement
Nausea visual analog scale
2
Description
Vomiting
Timepoint
Duration, 8,16,24 hours after intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Music Therapy
Category
Prevention
2
Description
Semi-fowler Position
Category
Prevention
3
Description
Without Intervention
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Center of Reza; Mashhad
Full name of responsible person
Mahbobe Pojhan
Street address
Faculty of Nursing & Midwifery of Tabriz
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Reshidi
Street address
Tabriz University of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Tabriz University of Medical Sciences
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing & Midwifery of Tabriz;Iran
Full name of responsible person
Alehe Seyedrasooli
Position
MS
Other areas of specialty/work
Street address
Shariety South St ; Faculty of Nursing & Midwifery of Tabriz ; Iran
City
Tabriz
Postal code
34751745
Phone
+98 41 1479 0364
Fax
+98 41 1479 6969
Email
seyyedrasooly@tbzmed.ac.ir
m_pozhhan@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)