Comparison of the effect of foot reflexology and cognitive behavioral therapy on symptoms of premenstrual syndrome in female students
Design
The sampling method is available and based on entry and exit criteria until the sample size is completed.
Allocation of samples in the studied groups is done by random block method.
The sample size was calculated based on the study of Başoğul et al. 36 people in each group. Taking into account the possibility of a 10% sample drop, the final volume in each group was estimated to be 40 people.
This research will be conducted as a randomized clinical trial with three groups in parallel.
Settings and conduct
This research will be conducted as a randomized clinical trial with three parallel groups. The research environment is the dormitories of Lorestan University of Medical Sciences in Khorramabad city. The studied population is female students of Lorestan University of Medical Sciences. After receiving the approval from the university's ethics committee, the researcher will provide the students with the PSST questionnaire form according to the entry criteria, in order to complete and diagnose the presence of PMS symptoms. This questionnaire is completed by students for two consecutive cycles before the start of the study, and based on the scores obtained in the questionnaire, people with moderate to severe PMS symptoms are placed in three study groups. No intervention is performed in the control group. The intervention groups undergo training and intervention for 8 weeks.
Participants/Inclusion and exclusion criteria
The samples of this study will be selected from the students who have moderate to severe symptomes according to the Premenstrual Symptoms Screening Questionnaire (PSST) and other inclusion criteria.
Intervention groups
foot reflexology
cognitive behavioral therapy
Control
Main outcome variables
Severity of premenstrual syndrome symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230509058131N1
Registration date:2023-05-18, 1402/02/28
Registration timing:registered_while_recruiting
Last update:2023-05-18, 1402/02/28
Update count:0
Registration date
2023-05-18, 1402/02/28
Registrant information
Name
Hanieh Barimani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3360 0613
Email address
cchangavi.f@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-10, 1402/02/20
Expected recruitment end date
2023-11-11, 1402/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of foot reflexology and cognitive-behavieral therapy on symptoms of premenstrual syndrome in female students
Public title
foot reflexology and CBT on PMS
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Regular menstrual cycle (21-35 days)
The presence of moderate to severe symptoms based on the PSST questionnaire from two cycles before entering the study
Living in a dormitory
Being single
Absence of symptoms of depression and anxiety based on the Dass_21 questionnaire
Not having special diets (vegetarianism, etc.)
Not having a physical education unit in the current semester
Exclusion criteria:
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of samples in study groups is done by random block method. In order to equalize the distribution of premenstrual syndrome severity, a class is created based on this variable as severe/moderate, and then by Block Randomization, and using the R software Blockrand package in 3 study groups in a balanced way. After the random sequence is determined by the epidemiologist, the researcher will identify and inform the epidemiologist of the female students who meet the criteria for entering the study, and the people will be divided into 3 control groups, reflexology groups based on the random sequence determined. Foot and cognitive behavioral therapy will be included.
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 Lorestan University of Medical Sciences
Street address
lorestan university of medical science, khorramabad
City
khorramabad
Province
Lorestan
Postal code
6816979151
Approval date
2023-05-06, 1402/02/16
Ethics committee reference number
IR.LUMS.REC.1402.042
Health conditions studied
1
Description of health condition studied
premenstrual syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Severity of premenstrual syndrome symptoms
Timepoint
before the start of the intervention and immediately after it and months 1 and 2
Method of measurement
PSST screening questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: foot reflexology
Category
Other
2
Description
Intervention group: cognitive behavioral therapy
Category
Behavior
3
Description
Control group: no intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Goldis dormity
Full name of responsible person
Hanieh Barimani
Street address
goldis apartment, naser khosro st
City
Khorramabad
Province
Lorestan
Postal code
6816979151
Phone
+98 66 3322 4547
Email
h.bmn076@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hanieh Barimani
Full name of responsible person
Hanieh Barimani
Street address
Goldis apartment, Naser Khosro st
City
Khorramabad
Province
Lorestan
Postal code
4819775377
Phone
+98 11 3360 0613
Email
h.bmn076@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hanieh Barimani
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
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Hanieh Barimani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Fahmideh 18 ave, mehrab 4 st, keshavarz Blvd
City
Sari
Province
Mazandaran
Postal code
4819775377
Phone
+98 11 3360 0613
Fax
Email
Cchangavi.f@lums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Hanieh Barimani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Fahmideh 18 ave, mehrab 4 st, keshavarz Blvd
City
Sari
Province
Mazandaran
Postal code
4819775377
Phone
+98 11 3360 0613
Fax
Email
Cchangavi.f@lums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Hanieh Barimani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Midwifery
Street address
Fahmideh 18 ave, mehrab 4 st, keshavarz Blvd
City
Sari
Province
Mazandaran
Postal code
4819775377
Phone
+98 11 3360 0613
Fax
Email
Cchangavi.f@lums.ac.ir
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
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
all data
When the data will become available and for how long
One year after the publication of the article
To whom data/document is available
Researchers and students
Under which criteria data/document could be used
Researchers and students
From where data/document is obtainable
Researcher
What processes are involved for a request to access data/document