Objectives: Compare of effects of progressive muscle relaxation and physical exercise on general health of pregnant women.
Design: This survey is experimental study and clinical trial. Samples of survey are selected by purposive based method and then randomly are divided to experimental and control Groups. The final volume in each group is 30 people.
Setting and conduct: experimental groups are performing training for 8 weeks and the results are recording in the daily report sheet. General health of the three groups is being measured before and after 8 weeks by the General Health Questionnaire (GHQ-28).
Participants including major eligibility criteria: age between 18-35 years old; single pregnancy; a wanted pregnancy first pregnant; have a maximum 12 week of gestation
Exclusion criterion: lack of regular and active participation in the intervention of relaxation or physical exercise.
Intervention: After teaching of progressive muscle relaxation and exercise groups, training were being performed for 8 weeks in home. In relaxation method that included gradual contraction and release fourteen groups of muscles, CD for training is available for participants to do at home. In exercise group intensity of training in walking is maintained in range of 50-65 percent of maximum heart rate, and is performed from15 minute in first week to 30 minute in eighth week. The control group does not receive any intervention.
The main outcome: Scores of general health in experimental and control groups in four dimensions of general health
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205159764N1
Registration date:2013-08-26, 1392/06/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-26, 1392/06/04
Registrant information
Name
Zahra Hajiamini
Name of organization / entity
Nursing Department, Baqiatallah University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2244 9062
Email address
z_hajiamini@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Baghiatollah University of Medical Science
Expected recruitment start date
2008-02-29, 1386/12/10
Expected recruitment end date
2008-05-09, 1387/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative survey of progressive muscle relaxation and physical exercise on general health of pregnant women
Public title
Comparative survey of progressive muscle relaxation and physical exercise on general health
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Between 18-35 years old; Have a minimum education necessary to read and understand the training provided; Single pregnancy; Prime pregnant with wanted pregnancy; Have a maximum of 12 weeks of gestation (first trimester); Low-risk pregnancies and no history of disease; Lack of specific drug; No smoking; drugs and alcohol; The absence of a history of recurrent miscarriage and not using fertility treatments
Exclusion criteria:
Having any kind of illness or hospitalization during the intervention; Lack of regular and active participation in the intervention, relaxation training or physical exercise
Age
From 18 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
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
Ethics Committee of Baghiatollah University of Medical Science
Street address
Baghiatollah University of Medical Science, Molasadra Street,Vanak Square,Tehran
City
Tehran
Postal code
Approval date
2008-03-10, 1386/12/20
Ethics committee reference number
326
Health conditions studied
1
Description of health condition studied
General Health of pregnant women
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
General Health of Pregnant Women
Timepoint
8 weeks after the intervention
Method of measurement
General Health Questionnair
Secondary outcomes
empty
Intervention groups
1
Description
Practical and theoretical training of progressive muscle relaxation group is performed for 3 sessions,1.5-2 hours in a week. Training are being performed at home for 8 weeks and twice a day and the results are being recorded in the daily report sheet
Category
Other
2
Description
Experimental groups are performing training for 8 weeks at least twice a day in home and recording the results in the daily report sheet.Training of exercise group is performed by researcher in lecture or questions and answers for 1.5-2 hours. Intensity of training is maintained in range of 50-65 percent of maximum heart rate. Walking for 8 weeks,3 sessions in week and every session based on the training protocol from15 minutes in first week to 30 minutes in eighth week is performed and the results are recorded in the daily report sheet.
Category
Other
3
Description
The control group does not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Women Clinic, Baghiatollah Hospital
Full name of responsible person
Zahra Bahrami
Street address
Women Clinic, Baghiatollah Hospital, Mollasadra Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for reseaech Baghiatollah University of Medical Science
Full name of responsible person
Dr. Morteza Izadi
Street address
Baghiatollah University of Medical Science, Mollasadra Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for reseaech Baghiatollah University of Medical Science
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
Akhtar Hospital, Shahid Beheshti Univercity of Medical Science
Full name of responsible person
Azam Sadeghi
Position
MS in Nursing
Other areas of specialty/work
Street address
Akhtar Hospital, Elahie
City
Tehran
Postal code
1964714953
Phone
+98 21 2200 1072
Fax
Email
a.sadeghi29151@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baghiatollah University of Medical Science
Full name of responsible person
Zahra Hajiamini
Position
MS of Midwifery
Other areas of specialty/work
Street address
Nursing Faculty of Baghiatollah University of Medical Science, Aghdasieh
City
Tehran
Postal code
Phone
+98 21 2228 9941
Fax
Email
z_hajiamini@bmsu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Akhtar Hospital, Shahid Beheshti University of Medical Science
Full name of responsible person
Azam Sadeghi
Position
MS in Nursing
Other areas of specialty/work
Street address
Akhtar Hospital, Elahie Street
City
Tehran
Postal code
1964714953
Phone
+98 21 2200 1072
Fax
Email
a.sadeghi29151@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)