Aims: Effect of warm shower and intravenous injection of hyoscine on the pain severity and duration of the active phase of labor in primiparous women
Design: Single-blind randomized clinical trial
Method: This study will be carried out in 29 Bahman Hospital of Tabriz. The subjects will be randomly assigned into three groups of 54 subjects with block sizes of 3 and 6 using computer software. In order to conceal allocation, the type of intervention will be written on a piece of paper and will be placed inside opaque sealed sequentially numbered envelops.
Participants: 162 nulliparous women.
Interventions: Two intervention groups will receive hot shower and intravenous Hyoscine injection and the control group will recieve no intervention. Hot shower will be firstly applied for 20 minutes at 4 cm dilation and then at 7 cm dilation. Also, Hyoscine will be injected at 4 cm dilation and then at 7 cm dilation, 20 mg in ml intravenously and diluted with 5 cc of distillated water. The duration of intravenous injection will be 1 to 2 minutes.
Main outcome measures include the pain severity and the duration of active phase that will be measured respectively by Visual Analogue Scale (VAS) and partograph form.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015012610324N22
Registration date:2015-06-05, 1394/03/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-05, 1394/03/15
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
: Effect of warm shower and intravenous injection of hyoscine on the pain severity and duration of the active phase of labor in primiparous women
Public title
: Effect of warm shower and intravenous injection of hyoscine on the pain severity and duration of the active phase of labor in primiparous women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Being primiparous; Spontaneous starting of labor pain; Not suffering from disease; Normal fetal heart rate according to CTG; Cephalic presentation based on ultrasound; Desire to participate in study.
Exclusion criteria: Having contraindication of normal delivery; Taking sedative and narcotic drugs during 48 hours prior to entering the study; Mental disorder history according to the patient's expression; Internal-surgical diseases including cardiovascular disease, thyroid disease, liver disease, kidney disease, asthma, epilepsy and etc according to the patient's expression; History of health problems in the current pregnancy according to the patient's expression; Participate in physiological childbirth classes.
Age
From 15 years old to 49 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
162
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 Tabriz University of Medical Sciences
Street address
Research Department of Tabriz University of Medical Sciences, Tabriz, Mohammad Reza Rashidi, Liberty Street, St. Golgasht, Tabriz University of Medical Sciences, Central Building No. 2, Third Floor, Research Department of Tabriz Tabriz
City
Tabriz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
93165
Health conditions studied
1
Description of health condition studied
Delivery
ICD-10 code
O80
ICD-10 code description
Single spontaneous delivery
Primary outcomes
1
Description
Labor pain severity
Timepoint
30 minutes after the intervention
Method of measurement
Visual Analogue Scale
2
Description
Duration of active phase of labor
Timepoint
From 4 cm dilation to full dilation
Method of measurement
Partograph form in terms of minute
Secondary outcomes
1
Description
Duration of second stage of labor
Timepoint
From full dilation until the newborn expulsion
Method of measurement
Partograph form in terms of minute
2
Description
Duration of third stage of labor
Timepoint
From newborn expulsion until placenta expulsion
Method of measurement
Partograph form in terms of minute
3
Description
Birth experience
Timepoint
12 to 24 hours postpartum
Method of measurement
Birth experience scale
Intervention groups
1
Description
The control group will receive no intervention.
Category
N/A
2
Description
The first intervention group will receive hot shower for 20 minutes at 4 cm and 7 cm dilation.
Category
Treatment - Other
3
Description
The second intervention group will receive Hyoscine at 4 cm and 7 cm dilation, 20 mg in ml intravenously diluted with 5 cc of distillated water.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
29 Bahman hospital of Tabriz
Full name of responsible person
Safa Madadi
Street address
29 Bahman Hospital, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Rashidi Mohammad Reza
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East Azerbaijan
City
Tabriz
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, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street, Tabriz
City
Tabriz
Postal code
51745-347
Phone
+98 41 3479 6770
Fax
+98 41 3479 6969
Email
Mirghafourvandm@tbzmed.ac.ir; Mirg1385@yahoo.com
Web page address
http://nursing.tbzmed.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street, Tabriz
City
Tabriz
Postal code
51745-347
Phone
+98 41 3479 6770
Fax
+98 414796969
Email
Mirghafourvandm@tbzmed.ac.ir; Mirg1385@yahoo.com
Web page address
http://nursing.tbzmed.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Safa Madadi
Position
MSc student in Midwifery
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street, Tabriz
City
Tabriz
Postal code
Phone
+98 49 2302 2778
Fax
Email
topmid62@yahoo.com
Web page address
http://aras.tbzmed.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)