Objective: the aim of this study is comparing the effect of massage and guided imagery on anxiety of nulliparous women during pregnancy referred to health centers in Zahedan city in 1395. This study is a randomized clinical trial with pretest and posttest control group. The studied population is nulliparous pregnant women with 75 sample size.Samples put in three groups of massage, guided imagery and control accidentally and then it continues until reaching the sample size. Inclusion criteria: singleton pregnancy; being in the second trimester; having literacy; lack of stressful life event during six months; disuse of any anti-anxiety medication; lack of physical illness that has health risks for her and her fetus by massage such as spinal cord injury or surgery; no history of recurrent pregnancy loss; lack of obstetric complications such as cervical cerclage. Exclusion criteria: the occurrence of stressful events or the creation of any obstetrical complication in the long run; childbirth during the study.Before intervention, revised questionnaire about pregnancy related to anxiety is completed. Exercises will be done once a week during six weeks (from 22 to 28 weeks of pregnancy). In addition, it will be asked the guided imagery group of participants to practice every day at home and record it in the form. Questionnaire is completed six weeks after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016070428794N1
Registration date:2016-07-30, 1395/05/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-07-30, 1395/05/09
Registrant information
Name
farnoosh khojasteh
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 33442481
Email address
khojasteh@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of massage and guided imagery during pregnancy on anxiety among nulliparous women
Public title
Comparing the effects of massage and guided imagery during pregnancy on anxiety among nulliparous women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 and 35 years; singleton pregnancy; being in the second trimester (22 to 28 weeks of pregnancy); Iranian race; having literacy; lack of stressful life event during six months; disuse of any anti-anxiety medication; do not use massage therapy and similar methods during pregnancy; lack of physical illness that has health risks for her and her fetus by massage such as spinal cord injury or surgery; the ability of the regular participation in meetings; no history of recurrent pregnancy loss; lack of drug addiction; lack of physical and mental illness; lack of obstetric complications such as cervical cerclage, placenta previa, high fever, premature rupture of membranesm, polyhydramnios. Exclusion criteria: the occurrence of stressful events or the creation of any obstetrical complication in the long run which has risk for the health of the mother or her baby such as high-blood pressure during pregnancy; A skin lesion at the site of massage that creates during massage; childbirth during the study; not desire to continue study; no intervention (listen to CDs less than three days a week).
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:
75
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
zahedan university of Medical Sciences
Street address
field doctor hesabi - College of Medical Sciences
City
zahedan
Postal code
Approval date
2015-12-27, 1394/10/06
Ethics committee reference number
IR.ZAUMS.REC.1394.343
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
anxiety
Timepoint
pre- intervention and 6 weeks after intervention
Method of measurement
Pregnancy related anxiety questionnaire - revised
Secondary outcomes
empty
Intervention groups
1
Description
In massage group, participants after pre-test have the head and neck, back, arms and legs massage for 20 minutes, once a week during six weeks (from 22 to 28 weeks gestation) in training classes for mothers in health centers equipped with facilities such as appropriate mats. First session will take about half an hour and other sessions take 20 minutes. In the first session, it will be explained about the causes of anxiety and ways to control it and the purpose of the intervention. To maintain patient privacy, the room where massage will be done is equipped with thick curtains and paravan. To maintain more privacy for patients during the massage, the room doors will be locked to prevent possible entry and exit.
Category
Behavior
2
Description
In the guided imagery group, intervention after pre-test will be done when participants receive the guided imagery techniques for 20 minutes, once a week during for six weeks (from 22 to 28 weeks gestation) in the training classes of health center. In addition, the registration daily workouts form will be given to the mothers. They have to listen to the CD in a quiet environment for 20 minutes every day, and insert it in the form. We called the mother twice a week while remind them of importance of exercise. Forms will be collected by a researcher at the next meeting.
Category
Behavior
3
Description
The control group will receive the routine and common care during pregnancy. At the end of the sixth week, we will call and invite them to participate in the post-test.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Jawad Health Center
Full name of responsible person
Parisa Zargari
Street address
City
Zahedan
2
Recruitment center
Name of recruitment center
Imam Hadi Health Center
Full name of responsible person
Cimin Lyaghat
Street address
City
Zahedan
3
Recruitment center
Name of recruitment center
Nastaran Health centers
Full name of responsible person
Zahra Dehbashi
Street address
City
Zahedan
4
Recruitment center
Name of recruitment center
Moaallem Health Center
Full name of responsible person
Batool Kaikavooci
Street address
City
Zahedan
5
Recruitment center
Name of recruitment center
Moses Ibn Jafar Health Center
Full name of responsible person
Zahra Meir
Street address
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Hoshang Rafighdost
Street address
University of Medical Sciences, Field docter Hesabi, Zahedan
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Esmat sahlabadi
Position
Masters student in the field Consultation of midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Square Of Mashahir, Zahedan
City
Zahedan
Postal code
Phone
+98 54 3344 2482
Fax
Email
Essahlabadi84@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Farnoosh khojasteh
Position
Master science
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Square Of Mashahir, Zahedan
City
Zahedan
Postal code
Phone
+98 54 3344 2482
Fax
Email
khojastehfarnoosh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Esmat sahlabadi
Position
Masters student in the field consultationof midwifery
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Square Of Mashahir, Zahedan
City
Zahedan
Postal code
Phone
00
Fax
Email
Essahlabadi84@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)