The aim of this study was to investigate the effect of chamomile on the severity of postoperative pain and post-cesarean anxiety in primipara mothers. Design: Double blind clinical trial with placebo method: In this study, after obtaining informed consent, patients will be randomly divided into two groups of intervention and control. 43 people will be in every group. Members of both groups at the first completed the questionnaire of visual acuity and Spilberger's apparent and hidden anxiety. Then the members of the intervention group inhale the chamomile fragrance for ten minutes, and the members of the control group inhale the distilled water. After 10 minutes of inhalation, again, in both groups, the intervention and control, the visual acuity questionnaire and Spilberger's apparent and hidden anxiety are completed. Inclusion criteria: age 18 to 35 years؛ use of spinal anesthesia؛ transverse incision؛ duration of operation less than 90 minutes؛ Iranian race؛ singleton pregnancy؛ absence of simultaneous surgery؛ Not having chamomile sensitivity؛ lack of anxiety disorders.
exclusion criteria: Inertia during or after surgery؛ Ileus.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052834169N1
Registration date:2017-09-05, 1396/06/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-05, 1396/06/14
Registrant information
Name
Zahra Iiman Panah
Name of organization / entity
Gonabad University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4333 6654
Email address
z.imanpanah@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Gonabad University Of Medical Sciences
Expected recruitment start date
2017-06-01, 1396/03/11
Expected recruitment end date
2017-07-31, 1396/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Chammomil fragrance impact on anxiety and pain after cesarean section in nulliparous women
Public title
Chammomil effect on pain and anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
inclusion criteria، 18 to35 years، the use spinal anesthesia، transects، opeation times less than 90 minutes، iranian race؛single pregnancy، no time surgery، insensivity to MC، the absence of anxiety disorders؛
exclusion criteria: ileus، inersi during or after operation.
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:
98
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Gonabad University Of Medical Sciences
Street address
Gonabad University Of Medical Sciences
City
Gonabad
Postal code
Approval date
2017-02-19, 1395/12/01
Ethics committee reference number
IR.GMU.REC.1395.124
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
f41.1
ICD-10 code description
Generalized anxiety disorder
2
Description of health condition studied
Pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
PAIN
Timepoint
10 MINUTES
Method of measurement
VAS
2
Description
anxiety
Timepoint
10minute
Method of measurement
spilberg anxiety inventory
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: Seven drops of chamomile fragrance for 10 minutes inhalation
Category
Treatment - Drugs
2
Description
control group: Seven drops of strill water for 10 minutes .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hakim Hospital، Neishaboor
Full name of responsible person
Dr Noori
Street address
Neishabour، Hakim Hospital
City
Neishabour
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gonabad University Of Medical Sciences
Full name of responsible person
Dr Alireza MohammadZadei
Street address
Gonabad University Of Medical Sciences
City
Gonabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad 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
Gonabad University Of Medical Sciences
Full name of responsible person
Zahra Iman panah
Position
expert
Other areas of specialty/work
Street address
Gonabad University Of Medical Sciences
City
gonabad
Postal code
Phone
+98 51 5722 3028
Fax
Email
imanpanah.64@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gonabad University Of Medical Sciences
Full name of responsible person
Dr Mohammad Mojalli
Position
Ph.D. in Nursing
Other areas of specialty/work
Street address
Gonabad University Of Medical Sciences
City
Gonabad
Postal code
Phone
+98 51 5722 3028
Fax
Email
mmojali@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Gonabad University Of Medical Sciences
Full name of responsible person
Zahra Iman Panah
Position
expert
Other areas of specialty/work
Street address
Hakim Hospital Of Neyshaboor
City
Neishabour
Postal code
Phone
+98 51 5722 3028
Fax
Email
imanpanah.64@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)