Comparison of the effect of ice massage on the Huko point (LI4) and SP6 on the severity of primary dysmenorrhea of students in two intervention groups and one control group
The aim of this study was to compare the effect of ice massage on the Huko point and SP6 on the severity of primary dysmenorrhea of female students.
Design
A single-blind clinical trial with a control group
Settings and conduct
This study was performed in dormitories in Zabol University of Medical Sciences. To this end, 90 students were selected and divided into three groups of 30 students each.
Participants/Inclusion and exclusion criteria
The inclusion criteria were painful menstrual periods in most menstrual cycles over the past year, Pain score of more than 4 based on visual pain assessment scale, aged 18 to 28 years, having regular menstruation (Duration of 3 to 7 days and two-twelve days from 21 to 35 days), No history of uterine and pelvic disorders, no pregnancy, no use of oral contraceptive pills and no history of abdominal or pelvic surgery. Exclusion criteria were smoking in the last six months, exercise professionally in the last six months, the presence of severe stressors in the last six months, Deaths of first-class family members, parental divorce, non-occurrence of menstruation, consumption of more than two dwellings during the study, using hot and cold therapy, taking herbal drugs to reduce menstrual pain and using massage techniques except of the accepted technique of study.
Intervention groups
first group: Ice massage was performed on Huko spot in a rotary manner daily for 20 minutes until the onset of primary dysmenorrhea.
Second group: Ice massage was performed on spatial 6 in a rotary manner daily for 20 minutes and until the onset of primary dysmenorrhea.
control group: In the control group, ice massage was performed on an inapplicable spot (except Huko and SP6 ) daily for 20 minutes and until the onset of primary dysmenorrhea.
Main outcome variables
Primary dysmenorrhoea
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180329039156N1
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
Hosien Shahdadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3222 5402
Email address
shahdadi@zbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-21, 1396/12/02
Expected recruitment end date
2018-03-22, 1397/01/02
Actual recruitment start date
2018-02-22, 1396/12/03
Actual recruitment end date
2018-03-24, 1397/01/04
Trial completion date
empty
Scientific title
Comparison of the effect of ice massage on the Huko point (LI4) and SP6 on the severity of primary dysmenorrhea of students in two intervention groups and one control group
Public title
Comparison of the effect of ice massage on the Huko point and SP6 on the severity of primary dysmenorrhea of students
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
painful menstrual periods in most menstrual cycles over the past year
Pain score of more than 4 based on visual pain assessment scale
aged 18 to 28 years,
having regular menstruation (Duration of 3 to 7 days and two-twelve days from 21 to 35 days)
No history of uterine and pelvic disorders
no use of oral contraceptive pills
o history of abdominal or pelvic surgery
Exclusion criteria:
smoking in the last six months
exercise professionally in the last six months
the presence of severe stressors in the last six months
Deaths of first-class family members
parental divorce
non-occurrence of menstruation
consumption of more than two dwellings during the study
using hot and cold therapy
taking herbal drugs to reduce menstrual pain
using massage techniques except of the accepted technique of study
Age
From 18 years old to 28 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method is stratified random then students are classified into three groups by block random allocation method.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants: That is, patients are aware of being involved in the study, but not aware of which group they are in at the time of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zabol University of Medical Sciences
Street address
Rajaei Ave, Zabol University of Medical Sciences, Zabol, Iran
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Approval date
2018-01-22, 1396/11/02
Ethics committee reference number
Zbmu.1.REC.1396.310
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea
Primary outcomes
1
Description
Primary dysmenorrhoea
Timepoint
Before intervention, After intervention
Method of measurement
VAS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: : Ice massage (2 cm in diameter inside a plastic bag) was performed on Huko spot in a rotary manner daily for 20 minutes until the onset of primary dysmenorrhea.
Category
Treatment - Other
2
Description
Intervention group: Ice massage (2 cm in diameter inside the plastic bag) was performed on spatial 6 in a rotary manner daily for 20 minutes and until the onset of primary dysmenorrhea.
Category
Treatment - Other
3
Description
Control group: In the control group, ice massage (2 cm in diameter inside the plastic bag) was performed on an inapplicable spot (except Huko and SP6 ) daily for 20 minutes and until the onset of primary dysmenorrhea.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Zabol University of Medical Sciences dormitories
Full name of responsible person
Hosien Shahdadi
Street address
Rajaei Ave, Zabol University of Medical Sciences, Zabol, Iran
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
86705503 21 0098
Phone
+98 54 3222 5402
Email
shahdadi@zbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Khadijeh Rezaeikahkha
Street address
Rajaei Ave, Zabol University of Medical Sciences, Zabol, Iran
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Phone
+98 54 3223 0768
Email
kh_rezaeikahkha@zbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol 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
Zabol University of Medical Sciences
Full name of responsible person
Hosien Shahdadi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Rajaei Ave, Zabol University of Medical Sciences, Zabol, Iran
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Phone
+98 54 3222 5402
Fax
Email
shahdadi@zbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Hosien Shahdadi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Rajaei Ave, Zabol University of Medical Sciences, Zabol, Iran
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Phone
+98 54 3222 5402
Fax
Email
shahdadi@zbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Hosien Shahdadi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Rajaei Ave, Zabol University of Medical Sciences, Zabol, Iran
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861663335
Phone
+98 54 3222 5402
Fax
Email
shahdadi@zbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
Some part of data
When the data will become available and for how long
Start of access to data from six months after publishing the paper.
To whom data/document is available
Universities.
Under which criteria data/document could be used
for more analysis only for some parts.
From where data/document is obtainable
PI Email: shahdadi@zbmu.ac.ir.
What processes are involved for a request to access data/document