Objectives: To investigate the Comparison effect of chewing flavourless and flavored with mint gum on stress and anxiety the first stage of labor in nulliparous women. Design: This is a randomized clinical trial on 90 nulliparous women that will be randomly assigned in 2case group(n=60) and control group(n=30). Setting and conduct: This study will be carried out in Ommol Banin hospital, Mashhad city. At the beginning of study for all subjects questionnaire demographic, family, labor, fatigue, hunger and perceived stress scale completed and Spielberger state-trait will be completed for all subjects and Saliva samples were taken to measure the stress. After 20 minutes of chewing gum in the 2case 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 in 7-5 cm dilatation will be included the study. Intervention: A sugar-free smile gum from will be used for 1case group and A sugar-free mint gum from will be used for 2case group. No intervention was performed in the control group. Main outcome measures variables: saliva cortisol level, anxiety level
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013011312108N1
Registration date:2013-02-09, 1391/11/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-02-09, 1391/11/21
Registrant information
Name
Seiede Fateme Alavian
Name of organization / entity
Mashhad univercity of medical sciente
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 1515
Email address
alavianf891@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2012-12-25, 1391/10/05
Expected recruitment end date
2013-04-25, 1392/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effect of chewing flavourless and flavored with mint gum on stress and anxiety the first stage of labor in nulliparous women
Public title
Comparison effect of chewing flavourless and flavored with mint gum on stress and anxiety the first stage of labor in nulliparous women
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria :Gestational age of 42-37 weeks ;
presence of at least 18 natural teeth in a good state of repair with the
ability to chew gum for at least 20 min at a time; Refrain from eating 1hourse before preparation of saliva samples;5-7 cm of cervical dilatation
Exclusion criteria: History of Medical and psychological disorders;Very mild or severe anxiety and stress;extreme hunger and fatigue
;Obstetric problems ;Develop symptoms of fetal distress Lack of saliva 5-3 ml.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
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 Mashhad University of Medical Sciences