Objectives: To investigate the effect of sugar-free chewing gum on labor anxiety and plasma cortisol levels.
Design: This is a randomized clinical trial on 80 nulliparous women that will be randomly assigned in case group(n=40) and control group(n=40).
Setting and conduct: This study will be carried out in Razi hospital, Ahvaz city. At the beginning of study systolic and diastolic blood pressure, pulse rate and plasma cortisol levels will be measured at intervals of uterine contractions and Spielberger state-trait will be completed for all subjects. In this questionnaire anxiety score is between 20 to 80. The scores between 20 to 49 and 50 to 80 are related to low and high anxiety levels, respectively. After 30 minutes of chewing gum in the case group, all variables will be measured for all subjects.
Participations including major eligibility criteria: All nuliparou18 to 35 years old women with a singleton term pregnancy in active phase of labor will be included the study.
Intervention: A sugar-free Orbit gum from Wrigley factory will be used for case group. No intervention was performed in the control group.
Main outcome measures variables: Systolic and diastolic blood pressure, pulse rate, plasma cortisol level, anxiety level.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109232204N2
Registration date:2011-10-03, 1390/07/11
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-10-03, 1390/07/11
Registrant information
Name
Somayeh Makvandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 916 604 2247
Email address
s-makvandi@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapour University of Medical Sciences
Expected recruitment start date
2011-10-07, 1390/07/15
Expected recruitment end date
2012-02-04, 1390/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sugar free chewing gum on labor anxiety and plasma Cortisol levels in nulliparous women
Public title
The effect of chewing gum on anxiety
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age 18-35; Gestational age between 37 to 42 weeks based on LMP or sonography under 26 weeks; Singleton fetus; Vertex presentation; 3-4 cm of cervical dilatation
Exclusion criteria: Vaginal bleeding; Abnormal fetal heart rate; Abnormality or death of fetus; Use of narcotic or anodyne drug or other pain reliever methods; Corporation in pre-labor education classes; History of psychological disorders; The recent death of a family member; Divorced women; Any history of chronic diseases
Age
From 18 years old to 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
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 Ahvaz Jundishapour University of Medical Sciences
Street address
Golestan highway
City
Ahvaz
Postal code
Approval date
2011-07-23, 1390/05/01
Ethics committee reference number
ETH-209
Health conditions studied
1
Description of health condition studied
Anxiety levels
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
Primary outcomes
1
Description
anxiety level of active phase of labor
Timepoint
30 min after intervention
Method of measurement
Spielberger state-trait
2
Description
plasma Cortisol levels
Timepoint
30 min after intervention
Method of measurement
Blood sample
3
Description
pulse rate
Timepoint
30 min after intervention
Method of measurement
examination
4
Description
Systolic BP
Timepoint
30 min after intervention
Method of measurement
examination
5
Description
Diastolic BP
Timepoint
30 min after intervention
Method of measurement
examination
Secondary outcomes
1
Description
duration of active phase of labor
Timepoint
at the end of study
Method of measurement
observation
2
Description
duration of second stage of labor
Timepoint
at the end of study
Method of measurement
observation
3
Description
mood of delivery
Timepoint
at the end of study
Method of measurement
observation
4
Description
oxytocin volume
Timepoint
at the end of study
Method of measurement
observation
Intervention groups
1
Description
Chewing of sugar-free Orbit gum for 30 minutes in the case group
Category
Prevention
2
Description
No intervention in the control group
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
ُShirin Zargar
Street address
Felestin Street
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Mostafa Feqhi
Street address
Golestan highway
City
Ahvaz
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, Ahvaz Jundishapour 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
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Simin Montazeri
Position
student of Reproductive Health (PhD)
Other areas of specialty/work
Street address
Golestan highway
City
Ahvaz
Postal code
Phone
+98 61 1373 8333
Fax
Email
mrssiminmintazeri@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Simin Montazeri
Position
student of Reproductive Health (PhD)
Other areas of specialty/work
Street address
Golestan highway
City
Ahvaz
Postal code
Phone
+98 61 1373 8333
Fax
Email
mrssiminmintazeri@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University . Ahvaz branch
Full name of responsible person
Somayeh Makvandi
Position
Master of midwifery. Research Assistant of Nursing and midwifery faculty
Other areas of specialty/work
Street address
Farhangshahr
City
Ahvaz
Postal code
Phone
+98 61 1334 8351
Fax
+98 61 1334 8351
Email
somayemakvandi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)