Protocol summary

Study aim
Comparison of the effect of hand reflexology and foot reflexology on periodic breast pain
Design
The study was conducted on the 90 female students suffering from cyclic breast pain. The participants were selected using the purpose sampling technique and divided into three groups: hand reflexology, foot reflexology and control. Prior to the study, the participants passed a reflexology massage training course and received educational pamphlets. An 8-minute session of reflexology was performed by the hand and foot reflexology groups in the last 14 days of two menstrual cycles. The severity of the periodic pain of the breast was measured by the pain visual scale and the duration of the pain was recorded in the daily pain table. Finally. The duration and severity of mastalgia changes were compared.
Settings and conduct
The place of sampling was Girls' dormitories
Participants/Inclusion and exclusion criteria
Inclusion criteria: being at the age of 15-45 years; BMI between 19.6_2; The length of menstrual cycle be regular and ranges between 21-35 days; breast pain during the last 14 days of the menstrual cycle; The average score of pain severity on the visual analogue scale be equal to 30-69. Non-inclusion criteria: Eating rich-fat diet or xanthine; being pregnant or intending to become pregnant during the study; Breastfeeding; Using hormonal medications since the last three months; Presence of abnormality in breast examination.
Intervention groups
The control group recorded the duration and severity of cyclic breast pain in the daily pain table and pain visual scale. Hand reflexology group performed an 8 -minute session of reflexology on the breast, upper lymphatic system and solar plexus zones in hands and filled daily forms. Foot reflexology group also performed reflexive massage on the mentioned zones in feet and filled forms.
Main outcome variables
Severity and duration of mastalgia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170508033868N2
Registration date: 2018-05-01, 1397/02/11
Registration timing: retrospective

Last update: 2018-05-01, 1397/02/11
Update count: 0
Registration date
2018-05-01, 1397/02/11
Registrant information
Name
Hamideh Safari
Name of organization / entity
Mashhad University of Medical Sciences Nursing and Midwifery Faculty
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
safarih941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-09-22, 1396/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of hand reflexology and foot reflexology on mastalgia among female college student
Public title
Comparison of the effect of hand reflexology and foot reflexology on periodic breast pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Filling out the written consent to participate in the research. Being a resident of the female' dormitory of Mashhad University of Medical Sciences. Age range of 15 -45 years. BMI range of 19.6 - 29. Having a regular menstruation cycle ranging from 21 to 35 days. Complaining of breast pain that occurred during the last 14 days of the menstrual cycle. Obtaining a minimum pain intensity score of 30-69 using the visual analogue scale.
Exclusion criteria:
Being a professional athlete؛ Eating rich-fat diet or diet containing xanthine. Pregnant or intend to become pregnant during the study. Breastfeeding. Experience of bad events in the past three months. Using hormonal medications or contraceptive pills since the last three months. Using the medicine to relieve pain during the last two months. Using a specific method to relieve breast pain. History of breast cancer in herself or her first-degree relatives. History of suspected breast mass in examination, mammography, or ultrasound. History of surgery on the breast or injection of gel or fat Having wound or lesion in the hands or feet. Having specific illness. Presence of physical disabilities. Presence of abnormality in breast examination.
Age
From 15 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Among the five dormitories of Mashhad University of Medical Sciences, three dormitories were selected randomly (with a draw) for the control group, hand reflexology group and foot reflexology group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomized and three groups

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Quraishi Building, Daneshgah street, Doctora Intersection, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2017-05-24, 1396/03/03
Ethics committee reference number
IR.MUMS.REC.1396.63

Health conditions studied

1

Description of health condition studied
mastalgia
ICD-10 code
N64.4
ICD-10 code description
Mastodynia

Primary outcomes

1

Description
Duration of pain
Timepoint
Two periods before the intervention and two periods during intervention(after one and two intervention cycles)
Method of measurement
Daily pain registry table

2

Description
Intensity of pain
Timepoint
Two periods before the intervention and two periods during intervention(after one and two intervention cycles)
Method of measurement
Pain visual Scale

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Without intervention, just in the last 14 days of the menstrual cycle, the duration of the period are recorded in the Daily pain registry table and the severity of periodic breast pain are assessed using pain visual scale.
Category
Diagnosis

2

Description
Intervention group 1: Hand reflexology, Doing daily 8 minutes of reflexology massage zones including Breast, upper lymphatic and solar plexus, on hand(With the intensity that felt numb in the place) in the last 14 days of the menstrual cycle and filling daily forms
Category
Treatment - Other

3

Description
Intervention group 2: foot reflexology, Doing daily 8 minutes of reflexology massage zones including Breast, upper lymphatic and solar plexus, on foot(With the intensity that felt numb in the place) in the last 14 days of the menstrual cycle and filling daily forms.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Girls Student Dormitories of Mashhad University of Medical Sciences
Full name of responsible person
Dr. Naderzadeh
Street address
Mashhad University of Medical Sciences, Bahonar Blvd, Vakil Abad Blvd.
City
Mahhad
Province
Razavi Khorasan
Postal code
00
Email
safarih941@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Quraishi Building, Daneshgah street, Doctora Intersection, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
91357-345
Phone
+98 51 3841 1536
Fax
+98 51 3843 7074
Email
safarih941@mums.ac.ir
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hamideh Safari
Position
Master student in Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Doctora intersection, Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
00
Phone
+98 51 3859 1511
Fax
Email
safarih941@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahin Tafazoli
Position
MSc in Midwifery
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Doctora intersection, Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
00
Phone
+98 51 3859 1511
Fax
Email
tafazolim@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamideh Safari
Position
Master student Midwifery
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Faculty of Nursing and Midwifery, Doctora intersection, Shariati Square
City
Mashhad
Province
Razavi Khorasan
Postal code
00
Phone
+98 51 3859 1511
Fax
Email
safarih941@mums.ac.ir
Web page address

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
Loading...