Investigating the effect of Swedish massage on pain syndrome, shoulder function and quality of life in women undergoing mastectomy referred to Kerman oncology centers in 2022
Investigating The effect of Swedish massage on pain syndrome, shoulder function and quality of life in women undergoing mastectomy
Design
The clinical trial has a control group and a sham group without blinding on 60 randomized patients.
Settings and conduct
The Swedish massage intervention will be performed by a trained nurse at Javad Al-Aameh Clinic and doctors' office in two intervention and sham groups without blinding for three weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: no stressful event in the last 6 months, no use of anticoagulants, no massage contraindications, no substance abuse.
Exclusion criteria: absence of more than two consecutive sessions
Intervention groups
The intervention group includes patients with breast cancer undergoing mastectomy who receive Swedish massage intervention.
The sham group includes breast cancer patients undergoing mastectomy who receive surface touch intervention.
Main outcome variables
Shoulder pain, quality of life, shoulder function, Swedish massage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221213056803N1
Registration date:2023-01-08, 1401/10/18
Registration timing:prospective
Last update:2023-01-08, 1401/10/18
Update count:0
Registration date
2023-01-08, 1401/10/18
Registrant information
Name
Zahra Rostami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3322 9141
Email address
z.rostami@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-21, 1401/11/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of Swedish massage on pain syndrome, shoulder function and quality of life in women undergoing mastectomy referred to Kerman oncology centers in 2022
Public title
The effect of Swedish massage in women undergoing mastectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having breast cancer without metastases to other areas
patients who have had one month of mastectomy surgery
the absence of stressful events in the past 6 months
the absence of using Painkillers, antiemetics or steroids
no contraindications to massage
Exclusion criteria:
Absence of more than two consecutive sessions of intervention
any severe physical disability that prevents the patient from participating in treatment sessions
Age
From 23 years old to 63 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization type: block,
Block size: 4 pieces,
Randomization Unit: Individual,
Randomization tool: R software,
Concealment: Using sealed opaque envelopes,
How people enter the random chain: People enter the random chain in the order of entering the study
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
Ethics Committee of Kerman University of Medical Science
Street address
Kerman, University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2022-11-22, 1401/09/01
Ethics committee reference number
IR.KMU.REC.1401.378
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
Disorders
ICD-10 code description
Disorders of breast(N60-N64)
Primary outcomes
1
Description
The score obtained from the quality of life European Organization for Research and Treatment of Cancer_EORCTquestionnaire
Timepoint
The effect of Swedish massage is measured three times before, immediately and one month after the intervention.
Method of measurement
The quality of life European Organization for Research and Treatment of Cancer_EORCTquestionnaire
2
Description
The score obtained from the shoulder function evaluation scale (shoulder disability) Shoulder Pain and Disability Index
Timepoint
The effect of Swedish massage is measured three times before, immediately and one month after the intervention.
Method of measurement
The shoulder function evaluation scale (shoulder disability) Shoulder Pain and Disability Index
3
Description
The score obtained from the shoulder function evaluation scale (pain) Shoulder Pain and Disability Index
Timepoint
The effect of Swedish massage is measured three times before, immediately and one month after the intervention.
Method of measurement
The shoulder function evaluation scale (Pain) Shoulder Pain and Disability Index
Secondary outcomes
empty
Intervention groups
1
Description
Patients in the intervention group will be treated for 3 weeks, 2 sessions a Week and 20 minutes each time from 14:00 to 17:00.
Category
N/A
2
Description
Control group: Sham group patients will be placed in the clinic for 3 Weeks, 2 sessions a week and 20 minutes each shift from 2:00 PM to 5:00 PM.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Javad Al-Aameh Clinic and Doctors Office
Full name of responsible person
Mohammad Hossein Pour Ebrahimi
Street address
No. 25, Abuzarshomali St., Kerman
City
Kerman
Province
Kerman
Postal code
7617763811
Phone
+98 34 3251 2098
Email
zahrarostami19273@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Abbas Pardakhti
Street address
The beginning of Haft Bagh, Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5177
Fax
Email
zahrarostami191273@gmail.com
Web page address
Grant name
Grant
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
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
Kerman University of Medical Sciences
Full name of responsible person
Zahra Rostami
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 8, Sedaghat Alley., No 7, vali asr Ave
City
Kerman
Province
Kerman
Postal code
7617615145
Phone
+98 34 3322 9141
Email
zahrarostami191273@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Mahlagha Dehghan
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
The beginning of Haft Bagh, Kerman University of Medical Science
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5177
Fax
+98 34 3132 5218
Email
m_dehghan86@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Zahra Rostami
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 8, Sedaghat Alley., No. 7, vali asr Ave
City
Kerman
Province
Kerman
Postal code
7617615145
Phone
+98 34 3322 9141
Email
zahrarostami191273@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only part of the information, such as the main outcome, is shared.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Academic and scientific institutions
Under which criteria data/document could be used
It is allowed to use in order to expand the science of complementary medicine. The condition for sending the application is to have a university affiliation.
From where data/document is obtainable
Email to the corresponding author, Dr. Meh Lagha Dehghan. Address: Nursing Research Center, Razi School of Nursing and Midwifery, Kerman University of Medical Sciences, Iran. Email: m_dehghan86@yahoo.com
What processes are involved for a request to access data/document
After checking the affiliation and the request via email sent to the responsible author and confirming the affiliation, the information will be provided to the researchers via email after one week.