Protocol summary

Summary
This is a randomized controlled trial which the primary outcomes measure include reducing fatigue and increasing quality of sleep in female students with Premenstrual Syndrome (PMS). Census sampling method will be used to screen PMS in the students of Islamic Azad University and Payam e Noor University in Bandar Genaveh, Bushehr Province. Then, 140 students with PMS and the inclusion criteria will be selected consecutively and randomly assigned to two groups of experiment (intervention) and control (with Blocking Randomization Method). The inclusion criteria include: students with fatigue and sleep quality score of 31 and 5, respectively; regular menstruation of 24-35 days; age of 18-35 years old; not married; no physical and mental diseases; no medication or traditional treatment for controlling PMS; The exclusion criteria consist no interest for participation in the trial anymore; performing incomplete acupressure for less than 6 consecutive days for any reason; irregular menses; get married during the trial; pharmacological or non-pharmacological treatments for PMS during the trial. For data collection, a self report questionnaire will be used for Premenstrual Syndrome diagnosis. Fatigue Severity Scale (FSS) and Pittsburg Sleep Quality Index (PSQI) will be used to measure the main dependent variables in the study. The independent variable will be acupressure on the points of ST36 – below the knee, in the anterior boarder of tibia and HT7 in the hands, at the wrist crease, on the radial side of the flexor carpi ulna is tendon, between the ulna and the pisiform bones. The intervention (acupressure) will be applied for 5 minutes on each points of the body. In other words, the total duration of intervention will be 20 minutes per day for 5-10 days premenstrual period in two consecutive cycles. The procedure of acupressure will be confirmed if subjects felt sore, numb, heavy, distended, and/or warm as a result of acupressure massage.

General information

Acronym
PMS
IRCT registration information
IRCT registration number: IRCT201206126247N6
Registration date: 2012-10-11, 1391/07/20
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-10-11, 1391/07/20
Registrant information
Name
Farideh Bastani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8857 2278
Email address
f-bastani@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2012-06-20, 1391/03/31
Expected recruitment end date
2012-09-20, 1391/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on improving quality of sleep and fatigue in female students with Premenstrual Syndrome (PMS)
Public title
Acupressure, sleep and fatigue in students with Premenstrual Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: students with fatigue and sleep quality score of 31 and 5, respectively; regular menstruation of 24-35 days; age between 18-35 years old; not married; no physical and mental diseases; no medication or traditional treatment for controlling Premenstrual Syndrome (PMS); Exclusion criteria: Unwillingness to continue participation in the trial; performing incomplete acupressure for less than 6 consecutive days for any reason; irregular menstruation; get married during the trial; pharmacological or non-pharmacological treatments for Premenstrual Syndrome during the trial.
Age
From 18 years old to 35 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 140
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This is an experimental study.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of Tehran University of Medical Sciences
Street address
Keshavarz Boulevard, Ghods St.
City
Tehran
Postal code
Approval date
2012-06-20, 1391/03/31
Ethics committee reference number
91/N/130/154

Health conditions studied

1

Description of health condition studied
Premenstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual Tension Syndrome

Primary outcomes

1

Description
Sleep Quality and Fatigue
Timepoint
pre and post intervention (before and after acupressure)
Method of measurement
Fatigue Severity Scale (FSS) and Pittsburg Sleep Quality Index (PSQI)

Secondary outcomes

empty

Intervention groups

1

Description
In this study, the intervention would be acupressure which will be applied for control of the PMS symptoms of fatigue and quality of sleep on the experiment group.
Category
Other

2

Description
The control group will be students who not exposed to acupressure or any interventions for the control of the PMS symptoms (fatigue and sleep quality).
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University and Payam e Noor University of Bandar Genaveh
Full name of responsible person
Bahare Mohammad Salehi
Street address
Bushehr Provice, Bander Genevah, Saheli St, opposit to Shahr e Shadi, Islamic Azad University of Bandar Genaveh
City
Bandar Genaveh

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotoohi, Vice Chancellor for Research, Tehran University of Medical Sciences
Street address
Keshavarz, Boulevard, Ghods St.
City
Tehran
Grant name
Grant code / Reference number
91-02-28-17955
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences, Faculty of Nursing & Midwifery
Full name of responsible person
Bahareh Mohamad Salehi
Position
MSc student in Nursing
Other areas of specialty/work
Street address
Tohid Square, Mirkhani St.,(Eastern Nosrat)
City
Tehran
Postal code
کد پستی 1419733171-
Phone
+98 21 6105 4416
Fax
+98 21 6690 4252
Email
b.salehi@gmail.com
Web page address
http://fnm.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences, Faculty of Nursing & Midwifery
Full name of responsible person
Farideh Bastani
Position
PhD in Health Education and Health Promotion
Other areas of specialty/work
Street address
Tohid Square, Mirkhani St., (Eastern Nosrat)
City
Tehran
Postal code
1419733171, P.O.BOX
Phone
+98 21610543416
Fax
+98 21 6690 4252
Email
f-bastani@sina.tums.ac.ir
Web page address
http://fnm.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences, Faculty of Nursing & Midwifery
Full name of responsible person
Bahareh Mohamad Salehi
Position
MSc student in Nursing
Other areas of specialty/work
Street address
Tohid Square, Mirkhani St., (Eastern Nosrat)
City
Tehran
Postal code
1419731171 P.O. BOX
Phone
+98 21 6105 4301
Fax
+98 21 6690 4252
Email
b.salehi@gmail.com
Web page address
http://fnm.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...