Assessment of the effect of matrica chamomillabreath on anxiety and pain of delivery on primigravida women who referred to Abhar Emdadi hospitals delivery room in 2013.
The aim of this study is to investigate the effect of matrica chamomilla aroma on anxiety and pain of delivery on primigravida women who referred to Abhar Emdadi hospitals delivery room in 2013. This is a randomized, single blind, placebo controlled‚ single centered phase II trial. Study population: Iranian primigravida women aged between 18 and 35, gestational age of 37-42 weeks who didn’t mention any auditory ‚ olfactory and neuro-psychic disorders; hadn’t taken any narcotics eight hours before any active phases in delivery process; hadn’t had any uterine surgery ‚ placenta previa ‚ history of cerclage and any indication for caesarian section. Exclusion criteria: The existence of any disorder in fetal heart rate ‚ placenta abruptia ‚ severe preeclampsia and any problem during labor, and being allergic to matrica chamomilla. Sample size is 126 women. In the intervention group two drops of chamomile were used on a guaze and was kept at a distance of 5 to 10 cm from the subject’s nose for one minute. In the control group two drops of distilled water were used in the same manner. Aroma therapy was repeated three times in half an hour intervals at 3-4, 5-7 and 8-10cm dilatations. Pain was measured using McGill pain scale before intervention and three times after aroma therapy at each dilatation. Anxiety was measured using spilberger questionnaire at the same intervals as pain’s.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201308066807N7
Registration date:2014-12-20, 1393/09/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-12-20, 1393/09/29
Registrant information
Name
Sedigheh Amir Ali Akbari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2272 9240
Email address
akbarisedd@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chanceller for research, Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of matrica chamomillabreath on anxiety and pain of delivery on primigravida women who referred to Abhar Emdadi hospitals delivery room in 2013.
Public title
Assessment of the effect of chamomile breath on anxiety and pain during delivery in primigravida women
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Iranian primagravida women aged between 18 and 35 with gestation age of 37-42 weeks who had live single fetus without any major anomaly and with cephalic presentation and having normal weight of 2500-3400 grams. Mother should have a normal Body Mass Index at the time of entry and shouldn’t have any auditory‚ olfactory and mental problems; not suffered from any special medical disorders‚ should not have any known acute and chronic nouro- psychic illnesses ; not taking any special neuro – psychic medicine; not having any acute and chronic pain like migraine; not taking any narcotics eight hours before any active phases in delivery process; not having any indication of caesarian like uterine surgeries ‚ placenta previa‚ cephalopelvic disproportion ‚ preeclampsia ‚ any history of cerclage and fetus distress ‚ any history of alcohol and narcotic addiction.
Exclusion criteria:
observing any kind of allergy or intolerance to chamomile; any disorders in labor process which led to bleeding; hypertension; disorders in fetus heart rate; prolapse of cord; placenta abruptia; prolonged rupture of membrane and inspecting meconium or making a decision to do delivery using instruments or surgery
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:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
According to sampling days , the candidates were categorized to two intervention and control group using pockets A and B.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences,Velenjak,Tehran
City
Tehran
Postal code
-
Approval date
2013-09-08, 1392/06/17
Ethics committee reference number
400/4013
Health conditions studied
1
Description of health condition studied
Pain and anxiety during normal delivery
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Pain
Timepoint
Pain was measured using McGill pain scale before intervention and three times after aroma therapy at each dilatation interval at 3-4, 5-7 and 8-10cm.
Method of measurement
McGill Pain Questionnaire
2
Description
Anxiety
Timepoint
Anxiety was measured using spilberger questionnaire before intervention and three times after aroma therapy at each dilatation interval at 3-4, 5-7 and 8-10cm.
Method of measurement
spilberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group two drops of chamomile were used on a guaze and was kept at a distance of 5 to 10 cm from the subject’s nose for one minute.
Category
Treatment - Other
2
Description
In the control group two drops of distilled water were used on a guaze and was kept at a distance of 5 to 10 cm from the subject’s nose for one minute.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Emdadi Abhar Hospital
Full name of responsible person
Abolhasan Rafiee
Street address
Emdadi Abhar Hospital, Khoramshahr Street, Abhar
City
Abhar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shahid Beheshti University of Medical Sciencs
Full name of responsible person
Doctor Masoume Simbar
Street address
Obstetrics department, Valiasr Street, Tehran
City
Tehran
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 Shahid Beheshti University of Medical Sciencs
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
School of Nursing, Midwifery Shahid Beheshti
Full name of responsible person
Solmaz Heydari Fard
Position
Master of Midwifery
Other areas of specialty/work
Street address
Obstetrics department, Valiasr Street, Tehran
City
Tehran
Postal code
-
Phone
+98 24 3522 4536
Fax
-
Email
Heydari_s88@yahoo.com
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Sedighe Amir Ali Akbari
Position
Ph.D. in Midwifery
Other areas of specialty/work
Street address
Obstetrics department, Valiasr Street, Tehran
City
Tehran
Postal code
-
Phone
+98 21 8820 2512
Fax
-
Email
asa_akbari@yahoo.com
Web page address
-
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)