Protocol summary

Summary
This study aimed to determine the effects of massage therapy on pain of labor, and its effect on pregnancy outcomes in nulliparous women was conducted on 66 pregnant mother. The intervention group (n = 33) under Petrissage massage (Peterissage) in the active phase of labor, dilatation of 4 cm and 8 cm in three stages and 10 cm, were in the back. The control group (n = 33) received only routine care nursing. In both physiological parameters and anthropometric measures and breast pain intensity at baseline were recorded. Also in the active phase in the intervention group and the control group after 30 minute massage routine after the pain was measured and the results were analyzed by t-test and SPSS16 software. Inclusion criteria: nulliparous women; age range 35-20 years age Hamlgy42-39 weeks, singleton, cephalic presentation, estimated fetal weight 4000-2500 g; bags of clean water, lack of drug addiction, lack of medical problems and psychological; the absence of contraindications for massage, onset of labor suits Exclusion criteria: the reluctance of mothers to continue to participate in the scheme; anything that the mother undergoing cesarean section.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015090723934N1
Registration date: 2015-09-20, 1394/06/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-09-20, 1394/06/29
Registrant information
Name
Tayebe Golchin
Name of organization / entity
Arak University of Medical Sceinces
Country
Iran (Islamic Republic of)
Phone
+98 86334172517
Email address
t.golchin@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy Minister for Research and Technology, Arak University of Medical Sciences
Expected recruitment start date
2014-02-24, 1392/12/05
Expected recruitment end date
2015-07-27, 1394/05/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the effect of massage therapy on Labor process & Outcomes of fetus
Public title
Study the effect of massage therapy on Labor process & Outcomes of fetus
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: nulliparous women; age range 35-20 years age Hamlgy42-39 weeks, singleton, cephalic presentation, estimated fetal weight 4000-2500 g; bags of clean water, lack of drug addiction, lack of medical problems and psychological; the absence of contraindications for massage, onset of labor suits Exclusion criteria: the reluctance of mothers to continue to participate in the scheme; anything that the mother undergoing cesarean section.
Age
From 20 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
N/A
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 Arak University of Medical Sciences
Street address
Alamolhoda, Maskan, Arak
City
Arak
Postal code
Approval date
2014-02-24, 1392/12/05
Ethics committee reference number
1045

Health conditions studied

1

Description of health condition studied
Delivery
ICD-10 code
O60
ICD-10 code description
Pregnancy with abortive outcome

Primary outcomes

1

Description
Labor pain
Timepoint
During delivery
Method of measurement
VAS

Secondary outcomes

1

Description
The first and fifth minute Apgar Newborn
Timepoint
1, 5 minutes after birth
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention Groups: under Petrissage massage in their active phase, three phase dilatation 4, 8 and 10 cm, were in the back.
Category
Treatment - Devices

2

Description
control group : only received routine care nursing
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital Arak
Full name of responsible person
Dr. tayebeh golchin
Street address
Taleghani Hospital Arak
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sceinces
Full name of responsible person
Dr. Mohammad Rafiee
Street address
Arak, School of Medicine
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sceinces
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
Arak University of Medical sceinces
Full name of responsible person
Dr. Tayebeh golchin
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Taleghani Hospital Arak
City
Arak
Postal code
Phone
+98 86 3313 7550
Fax
Email
T.golchin@arakmu.ac.ir;rahenorayaneh@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. tayebeh golchin
Position
Resident of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Taleghani Hospital Arak
City
Arak
Postal code
Phone
+98 86 3313 7550
Fax
Email
T.golchin@arakmu.ac.ir; rahenorayaneh@yahoo.com
Web page address

Person responsible for updating data

Contact

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
Loading...