Comparison effect of massage with lavender essence and just massage on intact perineum, episiotomy and perineal laceration in nulliparous women
laceration in nulliparous women
Objective : Comparison effect of perineal massage with Lavender Essence and just massage in second stage of labor in nulliparous . Inclusion criteria: nulliparity, cephalic presention, no complications an underlying disease.The study population: nulliparous women who were admitted for vaginal birth in Taleghany Maternity House.The sample size were 255 . They were placed in massage with Lavender Essence oil , just massage or control group during second stage of labour untile crowning.Rate of intact perineum, episiotomy and degree of laceration were determined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138802031839N1
Registration date:2012-05-10, 1391/02/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-05-10, 1391/02/21
Registrant information
Name
Mahtab Attarha
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 861417350009
Email address
m.attarha@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy of research of Arak Medical Sciences University & Bareej Essence Pharma.Co.
Expected recruitment start date
2007-04-04, 1386/01/15
Expected recruitment end date
2007-09-06, 1386/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of massage with lavender essence and just massage on intact perineum, episiotomy and perineal laceration in nulliparous women
laceration in nulliparous women
Public title
Effect of perineal massage in incidence of intact perineum during vaginal birth
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria (Inclusion criteria) - Term Pregnancy (42-38 weeks), nulliparous, singleton pregnancy, vertex presentation, without PROM, placental abruption, CPD, fetal distress,vaginal infections and herpes genitalia and not do Kegl Exersice. Exclusion criteria were as follows: distosia, fetal distress, use of sedative drugs , oparative delivery,the mother withdrew from continuing massage - allergies to lavender
Age
From 15 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
265
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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
38481-769410, Second Floor of Department of Educational affair, Pardis Building Comlex, Sardasht Sq. Arak University of Medical Sciences
City
Arak
Postal code
Approval date
2007-04-04, 1386/01/15
Ethics committee reference number
235
Health conditions studied
1
Description of health condition studied
Intact perineum, Episiotomy and Laceration
ICD-10 code
080
ICD-10 code description
Pregnancy, childbirth and the puerperium
Primary outcomes
1
Description
Intact perineum
Timepoint
postpartum
Method of measurement
With check list: to determine degree of laceration: intacte perineum without any injury
2
Description
frequency of episiotomy
Timepoint
cross sectional
Method of measurement
quantitative variables
3
Description
Intensity of perineal laceration
Timepoint
cross sectional
Method of measurement
qualitative were changed to quntative variables
Secondary outcomes
empty
Intervention groups
1
Description
intervent group: perineal massage with lavender essence oil,5-10 drops in 30-60 cc olive as carrier oil by the midwife, in second stage of labour until crowning of infantُs head, for 10 minutes
Category
Prevention
2
Description
Intervent group: just perineal massage by the midwife in second stage of labour until crowning of infantُs head for ten minutes
Category
Prevention
3
Description
Control group: no intervention
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghany Maternity House
Full name of responsible person
Mahtab Attarha
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor and Research of Arak University of Medical Sciences
Full name of responsible person
dvood Hekmatpoo Phd
Street address
Po Box: 38481-769410, Second Floor of Educational Department, Pardis Building Comlex Sardasht Sq. Arak University of Medical Sciences
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor and Research of Arak University of Medical Sciences
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Bareej Essence Pharmacotical Co
Full name of responsible person
Reza Bekhradi
Street address
1178, Delijan, Kashan Road
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bareej Essence Pharmacotical Co
Proportion provided by this source
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
Nursing Midwifery Faculty of Arak University of Medical Sciences
Full name of responsible person
Attarha Mahtab
Position
Sinior lecturer, Academician
Other areas of specialty/work
Street address
Vice Chancellor of Arak University of Medical Sciences
City
Arak
Postal code
Phone
+98 86 1417 3516
Fax
Email
mahtab_at2004@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak Medical Science University and Bareej Essence Pharmaco. Co
Full name of responsible person
Attarha M, Bekhradi R
Position
Academician and Dean of Clinical Research Department of Bareej Essence Co
Other areas of specialty/work
Street address
vice Chanceller of Arak Medical Sciences University
City
Arak & Kashan
Postal code
Phone
+98 86 1417 3516
Fax
Email
mahtab_at2004@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nursing Midwifery Faculty of Arak University of Medical Sciences
Full name of responsible person
Attarha M
Position
Other areas of specialty/work
Street address
Second Floor, Blue Wing, Nursing Midwifery Faculty, Sardasht Building Complex
City
Arak
Postal code
38481-769410
Phone
Fax
+98 86 1417 3524
Email
m.attarha@arakmu.ac.irmahtab_at2004@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)