Comparison of the effect of acupressure and ice massage at Hoku point on the severity of dysmenorrhea
Design
Clinical trial with control group, with parallel groups, single blind, randomized with permutation blocks, pilot study on 25 patients
Settings and conduct
Female medical students of Sirjan medical university are the target community.
Pain and demographic questionnaire is used.
The type of study is single blind.
After explaining the procedure, the process of performing ice therapy at the Hoku point on a group of students and acupressure at the Hoku point on another group and an group of ice balls at the adjacent Hoku massage point and the questionnaire will be completed. The researcher, who has already seen the necessary course and training under the supervision of the relevant expert, with moderate pressure of his thumb for 5 minutes in a clockwise direction. 5 minutes counterclockwise stimulates this point. In the acupressure group, only pressure was applied, and in the ice therapy group, pressure was applied to the ice ball at the Hoku point, and in the control group, the ice ball was slowly rotated near the actual Hoku site.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being single, experiencing painful menstruation in previous cycles, age between 18-28 years, no underlying disease
Exclusion criteria: interval from menarche time (first menstruation in women) less than 6 months and Having a specific disease or disorder.
Intervention groups
Intervention Group 1: Ice therapy at Hoku Point:
Ice therapy at Hoku point: Ice therapy with ice ball at Hoku point between thumb and forefinger
Intervention Group 2: Accupressure at Hoku Point:Acupressure at Hoko Point: Massage without Ice Ball at Hoko Point Protrusion between thumb and forefinger
Group 3: Control:Use an orb with the appearance of an icy ball near the protrusion of the index finger
Main outcome variables
Dysmenorrhea pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200624047911N1
Registration date:2021-02-05, 1399/11/17
Registration timing:retrospective
Last update:2021-02-05, 1399/11/17
Update count:0
Registration date
2021-02-05, 1399/11/17
Registrant information
Name
Naimeh Pourramezani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 4225 0449
Email address
npourramezani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-05, 1399/04/15
Expected recruitment end date
2020-08-05, 1399/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two methods of acupressure and massage with ice on hoku point on pain intensity
Public title
Comparison of the effect of two methods of acupressure and massage with ice on huko point on pain intensity
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Single
Experience painful menstruation in previous cycles
Age between 18-28 years
Regular menstrual cycle
Lack of diseases such as hormonal disorders, heart disease, thyroid, diabetes, asthma, kidney disease
History of medication such as corticosteroids, painkillers, contraceptives
Willingness to cooperate
No history of polycystic ovary disease
Exclusion criteria:
Less than 6 months before menarche (first menstruation in women)
The patient has cognitive impairment or mental illness
History of coagulation disorders.
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:
120
Randomization (investigator's opinion)
Randomized
Randomization description
In this pilot study using the method of randomization permutation blocks, 48 samples are randomly assigned in three equal groups. For this purpose, 8 blocks of 6 will be used.
Randomization unit: individual
Randomization tool: Random number table
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is an interventional study and a randomized clinical trial. This study is a single-blind study in the control group of a plastic ball that is exactly the same ice ball used in the intervention group but at a point close to the point Hoku (outside the main place) massage was applied.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sirjan University of Medical Sciences
Street address
Ebne Sina Street, Sirjan City, Kerman,Iran
City
Sirjan
Province
Kerman
Postal code
7817843153
Approval date
2020-09-13, 1399/06/23
Ethics committee reference number
IR.SIRUMS.REC.1399.029
Health conditions studied
1
Description of health condition studied
dysmenorrhea
ICD-10 code
N94
ICD-10 code description
Pain and other conditions associated with female genital organs and menstrual cycle
Primary outcomes
1
Description
The severity of menstrual pain is measured on a VAS scale.
Timepoint
Half an hour before the intervention, during the intervention, half an hour after the intervention
Method of measurement
VAS
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Ice therapy at Hoku point
Category
Behavior
2
Description
Intervention group: Massage on the hoku point
Category
Behavior
3
Description
Control group: Ice therapy near Hoku point
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Sirjan School of Medical Sciences
Full name of responsible person
Pourramezani Naimeh
Street address
Ebne Sina
City
Sirjan
Province
Kerman
Postal code
7817813343
Phone
+98 34 4220 5220
Email
npourramezani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sirjan School of Medical Sciences
Full name of responsible person
Research Assistant
Street address
Sirjan School of Medical Sciences، Ebne Sina
City
Sirjan
Province
Kerman
Postal code
7817813343
Phone
+98 34 4220 5220
Email
npourramezani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sirjan School 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
The University of Sirjan
Full name of responsible person
Naimeh Pourramezani
Position
Faculty instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No165, Gole Gohar Town,Malek e Ashtar Blvd, Sirjan, Kerman, Iran