This study is a randomized controlled clinical trial. The aim of this study is to evaluate the effect of massage therapy on depressive symptoms during pregnancy.The inclusion criteria included Gestational age less than 32 weeks ; Having a score greater than 9 and less than 18 from the Beck Depression Inventory; No history of medical or psychiatric disease; The lack of any medical or obstetrical complications in the current pregnancy; No history of miscarriage or preterm labor in previous pregnancies; ; No smokingl; Singleton pregnancy and exclusion criteria include:The occurrence of side effects; The use of sedation drugs or relaxation techniques during study; Absence in the intervention sessions more than 2 sessions. The research site is all health centers in the city of ilam.The sampling is easy and allocation of Samples in each intervention and control groups will be randomly.In the massage group the interventions including stroke massage on the back, which is done by the researcher. The intervention is carried out in health centers and be done with Vaseline oil.This intervention will be 6 sessions(three consecutive weeks, during two consecutive days each time for 20 minutes). No procedure will be performed in the control group.To assess the effects of massage therapy on symptoms of depression, Beck depression scale before, immediately after the intervention and four weeks after the intervention is completed by participants in the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013021112440N1
Registration date:2014-02-19, 1392/11/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-02-19, 1392/11/30
Registrant information
Name
Ziba Taghizade
Name of organization / entity
Tehran University of Medical Sciences school of nursing and midwifery
Country
Iran (Islamic Republic of)
Phone
+98 21 8824 4694
Email address
taghizad@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University of Medical Science
Expected recruitment start date
2014-01-16, 1392/10/26
Expected recruitment end date
2014-04-15, 1393/01/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of massage therapy on depression in pregnant women with mild depression
Public title
The effect of massage therapy on depression during pregnancy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Gestational age less than 32 weeks based on reliable LMP or ultrasound before 20 weeks of gestation in those who do not know your LMP; Having a score greater than 9 and less than 18 from the Beck Depression Inventory (mild depression); No history of recognized chronic or systemic disease; No personal or family history of mental illness or hospitalization due to recognized mental illness; The lack of any medical or obstetrical complications in the current pregnancy; No history of miscarriage or preterm labor in previous pregnancies; Not experienced stressful events during the 6 months before study; No smoking and drugs and do not drinking alcohol; Singleton pregnancy; Spontaneous pregnancy; No wound, infection or any other lesion on the back.
Exclusion criteria:The occurrence of side effects such as a reaction to the oil used during the intervention; Occurrence of any stressful event during the study; The use of sedation drugs or relaxation techniques during study; Absence in the intervention sessions more than 2 sessions.
Age
From 16 years old to 49 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
70
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 Tehran University of Medical Science
Street address
Vice Chancellor for Research,Tehran University of Medical Science, Ghods St, Keshavarz Bv.
City
Tehran
Postal code
Approval date
2013-06-01, 1392/03/11
Ethics committee reference number
130/399/د/92
Health conditions studied
1
Description of health condition studied
Mild depressive Disorder
ICD-10 code
F32.0
ICD-10 code description
Mild depressive episode
Primary outcomes
1
Description
Depression score
Timepoint
Before the intervention, immediately after intervention and 4 weeks after intervention
Method of measurement
Beck Depression Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The interventions including stroke massage on the back, which is done by the researcher(After training under the supervision of traditional medicine And obtain the required certificate to do it). The intervention is carried out in health centers and be done with Vaseline oil.This intervention will be 6 sessions (Three consecutive weeks, during two consecutive days each time for 20 minutes)
Category
Treatment - Other
2
Description
Control group : No procedure will be performed in the control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Number one urban health center
Full name of responsible person
Street address
Next to Tarbiat school, Ayatollah Haidari St.
City
Ilam
2
Recruitment center
Name of recruitment center
Number two urban health center
Full name of responsible person
Zohre Ahmadi
Street address
Behind Vali Castle, Takhti St.
City
Ilam
3
Recruitment center
Name of recruitment center
Number three urban health center
Full name of responsible person
Zohre Ahmadi
Street address
Shahid Hemmat karami st, Intersection Resalat.
City
Ilam
4
Recruitment center
Name of recruitment center
Numder seven urban health center
Full name of responsible person
Zohre Ahmadi
Street address
Beasat street, Jomhori Boulevard.
City
Ilam
5
Recruitment center
Name of recruitment center
Number four urban health center
Full name of responsible person
Zohre Ahmadi
Street address
Imam Northern Blvd.
City
Ilam
6
Recruitment center
Name of recruitment center
Number five urban health center
Full name of responsible person
Zohre Ahmadi
Street address
Edalat street.
City
Ilam
7
Recruitment center
Name of recruitment center
Numder Six urban health center
Full name of responsible person
Zohre Ahmadi
Street address
Below the Shahid Mustafa Khomeini Hospital.
City
Ilam
8
Recruitment center
Name of recruitment center
Number eight urban health center
Full name of responsible person
Zohre Ahmadi
Street address
Edalat street
City
Ilam
9
Recruitment center
Name of recruitment center
Number nine urban health center
Full name of responsible person
Zohre Ahmadi
Street address
Alleys Abdullahi, Street 24 yard.
City
Ilam
10
Recruitment center
Name of recruitment center
Number ten urban health center
Full name of responsible person
Zohre Ahmadi
Street address
Hor street.
City
Ilam
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Cheraghi
Street address
Vice Chancellor for Research,Tehran University of Medical Sciences. Ghods St. Keshavarz Bv.
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 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
Full name of responsible person
Zohre Ahmadi
Position
MSc student
Other areas of specialty/work
Street address
Alley Khalil Taba, Beasat st.
City
Ilam
Postal code
6931749331
Phone
+98 84 1334 1520
Fax
Email
zohre.ahmadi7025@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zohre Ahmadi
Position
MSc studen
Other areas of specialty/work
Street address
Alley Khalil Taba, Beasat st.
City
Ilam
Postal code
6931749331
Phone
+98 84 1334 1520
Fax
Email
zohre.ahmadi7025@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zohre Ahmadi
Position
MSc student
Other areas of specialty/work
Street address
Alley Khalil Taba, Beasat st.
City
Ilam
Postal code
6931749331
Phone
+98 84 1334 1520
Fax
Email
zohre.ahmadi7025@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)