Compare the effect of two educational program of progressive muscle relaxation and guided imagery on sleep quality of primigravide women referred to health centers of Mashhad.
This study will be done with aim of comparing the effects of Progressive Muscle Relaxation and Guided Imagery on sleep quality of pregnant women. Methods : This study will be clinical trial. Inclusion criteria included 18-35 years old primigravida women, singleton pregnancy with gestational age of 29-32 weeks and earn a score of 5 or higher in Pittsburgh Sleep Quality index (PSQI).100 of pregnant women reffered to health centers of Mashhad Randomly will be allocated to three groups of Progressive Muscle Relaxation and Guided Imagery and control. Then, every 10 days will be allocated to one of three groups mentioned. For two groups of intervention , relaxation training sessions will be held in 45-60 minutes . At the end of the session, a Bvklt about sleep hygiene, relaxation CD and daily record sheet will be gave to research units. Pregnant women will done the exercises twice a day for 4 weeks using a relaxation CD at home and after each time, the data will be recorded in the daily record sheet. at the end of each week, researcher will discuss with phone calls about the research units relaxation exercises and problems. 4 weeks After intervention, Pittsburgh Sleep Quality Index (PSQI) will be completed again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014042917488N1
Registration date:2014-06-07, 1393/03/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-06-07, 1393/03/17
Registrant information
Name
Farnaz sadat Seyed ahmadi nejad
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 1511
Email address
seyedaf911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2014-03-20, 1392/12/29
Expected recruitment end date
2014-08-21, 1393/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of two educational program of progressive muscle relaxation and guided imagery on sleep quality of primigravide women referred to health centers of Mashhad.
Public title
Compare the effect of two educational program of progressive muscle relaxation and guided imagery on sleep quality
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:( Iranian and resident of Mashhad ؛has the phone number to call؛
18-35 years old primi gravida women؛ Singleton pregnancy with gestational age of 32-29 weeks؛ sub diploma minimum education؛ did not occurred Stressful life events in the past six months؛ did not suffer from physical and mental illness؛has not obstetric problems؛ during pre-pregnancy, did not treat for sleep disorder؛ before pregnancy BMI did not equal to or greater than 29 ؛ not addict to drugs, alcohol, cigarettes or hookah؛ do not use Relaxation techniques during pregnancy؛ During the study, has not night shifts؛ In Pittsburgh Sleep Quality Index (PSQI) earn score of 5 or higher).
Exclusion criteria during study: (obstetric complications occurred ؛ stressful events occurred؛ delivery occured during the study).
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
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
Mashhad University of Medical Sciences
Street address
central building of Mashhad University of Medical Sciences, Daneshgah Avenue
City
Mashhad
Postal code
Approval date
2014-04-26, 1393/02/06
Ethics committee reference number
research/922247/1/824
Health conditions studied
1
Description of health condition studied
sleep disorder
ICD-10 code
G47.0
ICD-10 code description
Disorders of initiating and maintaining sleep [insomnias]
Primary outcomes
1
Description
sleep quality
Timepoint
pre- intervention and 4 weeks after intervention
Method of measurement
pitsborg sleep quality index
Secondary outcomes
empty
Intervention groups
1
Description
In the progressive muscle relaxation group, two sessions of relaxation training will hold during 45-60 minutes. Finally, an educational bvklt about sleep hygiene and CD of progressive muscle relaxation will give to the subjects and they will be ask to do relaxation practices twice a day (morning and half an hour before bed at night) for 4 weeks. At the end of each week, researcher will call and speak about the practice and the their potential problems. 4 weeks after the start of study the Pittsburgh Sleep Quality Index will be completed again.
Category
Behavior
2
Description
In the guided imagery relaxation group, two sessions of relaxation training will hold during 45-60 minutes. Finally, an educational bvklt about sleep hygiene and CD of guided imagery relaxation will give to the subjects and they will be ask to do relaxation practices twice a day (morning and half an hour before bed at night) for 4 weeks. At the end of each week, researcher will call and speak about the practice and the their potential problems. 4 weeks after the start of study the Pittsburgh Sleep Quality Index will be completed again.
Category
Behavior
3
Description
In the control group, at the end of each week telephone contact is established in order to maintain contact. After 4 weeks, the Pittsburgh Sleep Quality Index will be completed again.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ab-o-bargh ,Lashgar Health centers and Omolbanin hospital
Full name of responsible person
Street address
City
mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Central building of Mashhad University of Medical Sciences, Daneshgah avenue
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Farnaz sadat Seyed ahmadi nejad
Position
Master science student of Midwifery
Other areas of specialty/work
Street address
Ebne-sina street, Doktora cross.
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
seyedaf911@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Golmakani
Position
Master science of Midwifery
Other areas of specialty/work
Street address
Ebne-sina street, Doktora cross.
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
golmakanin@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farnaz sadat Seyed ahmadi nejad
Position
Master science student of Midwifery
Other areas of specialty/work
Street address
Ebne-sina street, Doktora cross
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
seyedaf911@mums.ac.irf_seyedahmadi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)