Protocol summary

Summary
Comparison of relaxation and Valerian on insomnia in menopausal women - random - no blindness - a placebo . Study population: qualified volunteers inclusion . Main inclusion criteria : 1 ) at least one year has passed since the last menstrual discontinued after natural menopause; 2 ) lack of mental and physical diseases such as musculoskeletal disorders or paralysis, and…; 3 ) lack of sedative drugs; 4) the lack of smoking and alcohol: 5 ) failure , liver disease , kidney and gastrointestinal: 6 ) no history of cancer; 7 ) not using hormone therapy within 3 months ; 8 ) not suffering from high blood pressure . Exclusion criteria included : 1 ) the creation of any physical illness and mental During the study period , causing obstructive sleep apnea; 2 ) the emergence of a significant change sleep conditions as unpredictable as travel , shift or taking any medications , and additional material during study; 3 ) Do not use Valerian maximum period of seven consecutive days during the study period 4 ) unwillingness to cooperate . volumes of sample : 129 subjects selected randomly from the population and divided them into three groups of 43 individuals qualified ( Group Valerians training relaxation and control) intervention study Group plant Valerian taken twice a day capsules of 530 mg Sedamin capsule before bed for a month , the group relaxation participate in classroom training 2 times per week for 2 hours and daily exercises for a month , the control group ( taking capsules of placebo containing 50 mg of starch is twice a day for a month . completing form : early intervention and 4 weeks later, both groups in the outcome of the study : comparing the educational effectiveness relaxation and lavender on menopausal insomnia

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014022516743N1
Registration date: 2014-04-12, 1393/01/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-04-12, 1393/01/23
Registrant information
Name
Atefeh Kargosha
Name of organization / entity
Fatemeh College of Nursing And Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4258
Email address
kargosha@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University Of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2014-07-20, 1393/04/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of relaxation training and Valerian on insomnia of menopause women
Public title
Comparison of relaxation training and Valerian on insomnia of menopause women
Purpose
Treatment
Inclusion/Exclusion criteria
Main inclusion criteria : 1 ) at least one year has passed since the last menstrual discontinued after natural menopause; 2 ) lack of mental and physical diseases such as musculoskeletal disorders or paralysis, and…; 3 ) lack of sedative drugs; 4) the lack of smoking and alcohol: 5 ) failure , liver disease , kidney and gastrointestinal: 6 ) no history of cancer; 7 ) not using hormone therapy within 3 months ; 8 ) not suffering from high blood pressure . Exclusion criteria included : 1 ) the creation of any physical illness and mental During the study period , causing obstructive sleep apnea; 2 ) the emergence of a significant change sleep conditions as unpredictable as travel , shift or taking any medications , and additional material during study; 3 ) Do not use Valerian maximum period of seven consecutive days during the study period 4 ) unwillingness to cooperate.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
None
Sample size
Target sample size: 129
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University Of Medical Sciences
Street address
Shiraz University of Medical Science Building, Zand Ave, Shiraz
City
ُShiraz
Country
Iran (Islamic Republic of)
Postal code
7193613119
Approval date
2014-02-12, 1392/11/23
Ethics committee reference number
CT.92.6885

Health conditions studied

1

Description of health condition studied
insomnia
ICD-10 code
F51.0
ICD-10 code description
Nonorganic insomnia

Primary outcomes

1

Description
insomnia
Timepoint
Early intervention and after 1 month in all three groups
Method of measurement
Standardized questionnaire Petersburg

Secondary outcomes

empty

Intervention groups

1

Description
Valerian group, taken twice a day capsules of 530 mg Valerian, oral capsule Sedamin before bed for a month
Category
Treatment - Drugs

2

Description
Relaxation training, participation in classes 2 times a day for the first week and then do the exercises at home
Category
Other

3

Description
Control group, placebo containing Starch 50 mg 2 times a day for a month
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Motahari Clinic
Full name of responsible person
Mrs Halaj
Street address
Namazi square, Shiraz
City
Shiraz
Country
Iran (Islamic Republic of)

2

Recruitment center
Name of recruitment center
Hazrat Zainab hospital
Full name of responsible person
Mrs Shahbazi
Street address
Defae Moghadas square
City
Shiraz
Country
Iran (Islamic Republic of)

3

Recruitment center
Name of recruitment center
Hafez hospital
Full name of responsible person
Mrs Mahtab Tabrizian
Street address
Chamran Blvd, Shiraz
City
Shiraz
Country
Iran (Islamic Republic of)

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Gholam Reza Hatam
Street address
7th Flat, Central department of Shiraz University of Medical Sciences, Zand Street, Shiraz
City
Shiraz
Country
Iran (Islamic Republic of)
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, Shiraz 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
Fatemeh (PBUH) College of Nursing and Midwifery
Full name of responsible person
Azam Jokar
Position
Faculty Member, MSc in Midwifery
Other areas of specialty/work
Street address
Namazi square, Shiraz
City
shiraz
Country
Iran (Islamic Republic of)
Postal code
Phone
+98 71 1647 4258
Fax
Email
Jokarhs@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Fatemeh College of Nursing And Midwifery
Full name of responsible person
Azam Jokar
Position
Faculty Member, MSc in Midwifery
Other areas of specialty/work
Street address
Namazi Square, Shiraz
City
Shiraz
Country
Iran (Islamic Republic of)
Postal code
Phone
+98 71 1647 4258
Fax
Email
Jokarhs@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Fatemeh (PBUH) College of Nursing and Midwifery
Full name of responsible person
Atefeh Kargosha
Position
Student, MSc in Midwifery
Other areas of specialty/work
Street address
Namazi square, Shiraz
City
Shiraz
Country
Iran (Islamic Republic of)
Postal code
Phone
00
Fax
Email
ati.kargosha@yahoo.com
Web page address

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
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