Protocol summary

Summary
Aim: The effect of rosewater aromatherapy on reducing labor pain in primiparous women Inclusion criteria: Nulliparous women, Gestational age of 37 weeks until 42 weeks, Singleton Exclusion criteria: Using other methods of pain relief during the study, Labor complications after intervention, Patient intolerance The study population: The nulliparous women in 38-42 weeks pregnancy that admitted to Arak΄s Taleghani Hospital for vaginal delivery The sample size: One hundred and eleven nulliparous women including 1- Rosewater (N=37) 2-placebo (N=37) and 3- control (N=37) group Intervention: Women randomly were divided to three groups, including rosewater, placebo (water) and negative control group. In initial study (5-4 cm dilation) labor pain intensity was determined by pain visual analogue scale. Then the client was asked to inhale rosewater or placebo in dilatation of 5-7 and 8-10 cm. In control group, routine care was conducted by the researcher assistant Pain intensity was measured before and 30 minutes after intervention and also dilatation of 10 cm. Outcome: labor pain intensity

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014110914450N3
Registration date: 2014-12-22, 1393/10/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-12-22, 1393/10/01
Registrant information
Name
Nasrin Roozbahani
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 633684615
Email address
roozbahani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Arak University of Medical Sciences
Expected recruitment start date
2012-02-13, 1390/11/24
Expected recruitment end date
2013-01-18, 1391/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of rosewater and placebo on reducing labor pain in primiporous women
Public title
The effect of rose water aromatherapy on reducing labor pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Nulliparous women; Gestational age of 37 weeks until 42 weeks; Singleton; Cephalic presentation; 4 to 5 cm dilation Exclusion criteria: Using other methods of pain relief during the study; Labor complications after intervention; Patient intolerance
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 111
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
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
Arak University of Medical Sciences, Pardis Danshgae, Basij square, Arak, Iran
City
Arak
Postal code
6941-7-38481
Approval date
2009-02-19, 1387/12/01
Ethics committee reference number
24-1-87

Health conditions studied

1

Description of health condition studied
labor pain
ICD-10 code
080.0
ICD-10 code description
Spontaneous vertex delivery

Primary outcomes

1

Description
severity Labor pain
Timepoint
before and 30 min after intervention
Method of measurement
visual analogue scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In initial study (5-4 cm dilation) labor pain intensity was determined by pain visual analogue scale. Then the client was asked to inhale rosewater in dilatation of 5-7 and 8-10 cm. Pain intensity was measured before and 30 minutes after intervention and also dilatation of 10 cm.
Category
Treatment - Drugs

2

Description
Placebo group: In initial study (5-4 cm dilation) labor pain intensity was determined by pain visual analogue scale. Then the client was asked to inhale water (placebo) in dilatation of 5-7 and 8-10 cm. Pain intensity was measured before and 30 minutes after intervention and also dilatation of 10 cm.
Category
Placebo

3

Description
Control group: In initial study (5-4 cm dilation) labor pain intensity was determined by pain visual analogue scale. Routine care was conducted by the researcher assistant. Pain intensity was measured in dilatation of 5-7 and 8-10 cm and 30 minutes later and also dilatation of 10 cm.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Taleghani‏ Hospital
Full name of responsible person
Dr. Nasrin Roozbahani
Street address
Ayatollah Taleghani‏ Hospital, Imam khomeini street, Arak, Iran
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Arak University of Medical Sciences
Full name of responsible person
Dr. Aliasgar Yagobi
Street address
Arak University of Medical Sciences, Pardis Danshgae, Basij square, Arak, Iran
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 for research of Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr. Nasrin Roozbahani
Position
Faculty member
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Pardis Danshgae, Basij square, Arak, Iran
City
Arak
Postal code
38181-4-6851
Phone
+98 86 3368 4615
Fax
Email
roozbahani@Gmail.com; roozbahani@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Nasrin Roozbahani
Position
Ph.D of Health Education
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Pardis Danshgae, Basij square, Arak, Iran
City
Arak
Postal code
38181-4-6851
Phone
+98 86 3368 6443
Fax
Email
roozbahani@Gmail.com; roozbahani@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Nasrin Roozbahani
Position
Ph.D of Health Education
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Pardis Danshgae, Basij square, Arak, Iran
City
Arak
Postal code
38181-4-6851
Phone
+98 86 3368 4615
Fax
Email
roozbahani@Gmail.com; roozbahani@arakmu.ac.ir
Web page address

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
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