Protocol summary

Summary
Study is double blind clinical trial comparative study of inhalation of chamomile essense versus plasebo on post operative pain reliefe in cesarean surgery.128 women, referred to mashhad Imam Reza Hospital operating room for cesarean surgery randomly devide into 2 groups.Inclusion criteria: The same type of anesthesia (spinal anesthesia) and anesthetic used; 38 to 42 weeks of gestational age; Nulli parous. exclusion criteria:Reluctance to continue participating in the exercises; Use powerful hypnotics or analgesics drugs; Having allergy and breathing problems; History of warfarin they will undergo spinal anesthesia and cesarean section will be performed.When the post-operative pain starts, and 4, 8, and 12 hours after that, patients will undergo aromatherapy using chamomile essence. patient’s pain score is measured using VAS and quality of pain is measured using McGill questionnaire. then ipatients in the case group will be requested to breathe over a piece of cotton containing 1 drops of the 5 % chamomile essence oil from a distance of 5 cm for 10-20 minutes, then the pain score will be measured again.If the score is > 4, 100 mg of IM Diclofenac will be prescribed.In control group the same procedures will be performed, but instead of the chamomile essence, 1 drops of placebo will be used. The heart rate, blood pressure, nausea, vomiting, dizziness and satisfaction will be recorded before and after the aromatherapy according to the questionnaire. After starting an IV line, patients will be given 500 ml of ringer solution. Then, they will undergo spinal anesthesia

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2016042427558N1
Registration date: 2016-10-09, 1395/07/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-10-09, 1395/07/18
Registrant information
Name
Ameneh Basiri
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4401 1004
Email address
basiria2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Sabzevar University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-10-22, 1394/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effectiveness of essential oils of chamomile or placebo on intensity and quality of pain after cesarean section
Public title
The effect of chamomile Essense on Cesarean post operative pain relief
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Consent for participation in the study; Ability to speake Farsi The same type of anesthesia (spinal anesthesia) and anesthetic used; 38 to 42 weeks of gestational age; Nulli parous. exclusion criteria:Reluctance to continue participating in the exercises; Use powerful hypnotics or analgesics drugs; Having allergy and breathing problems; History of warfarin
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 128
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
Sabzevar University of Medical Sciences
Street address
School of Nursing and Midwifery; Next to the Police Station to SHahroud road, Sabzevar
City
Sabzevar
Postal code
Approval date
2015-03-09, 1393/12/18
Ethics committee reference number
Medsab.Rec.93.123

Health conditions studied

1

Description of health condition studied
pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain

Primary outcomes

1

Description
Pain Intensity
Timepoint
befor of aromatherapy and after 20 minute
Method of measurement
Visual Analog Scale

Secondary outcomes

1

Description
Pain Quality
Timepoint
befor of aromatherapy and after 20 minute
Method of measurement
Modify Short Form McGill Pain Questionnaire

Intervention groups

1

Description
In the intervention group 1 drop essential oil of chamomile 5% on the pad (small gas) dropped and the patient is asked at a distance of 5 cm from nose to breathe for 20-15 minutes and then again on the half hour pain intensity using tools McGill pain questionnaire measuring visual short in the control group was given a placebo
Category
Placebo

2

Description
1 drop of placebo-treated control group on gas and at a distance of 5 cm from the nose and breathe for 15-20 minutes.And then the intensity and quality of pain was measured using the tools mentioned questionnaire.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Center of Education, Research and Treatment of Imam Reza
Full name of responsible person
Roqiyeh Zardosht
Street address
Shariati square - Mashhad - Khorasan Razavi
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Moosa Reza Tadayonfar
Street address
School of Nursing and Midwifery; Next to the Police Station to SHahroud road, Sabzevar
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Ameneh Basiri
Position
Master Student Critical Care Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Next to the Police Station to SHahroud road, Sabzevar Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4426 4430
Fax
Email
basiria2@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Roqiyeh Zardosht
Position
BSN, MSN, Ph.D candidate of Nursing. Faculty Member of Sabzevar University of Medical Sciences
Other areas of specialty/work
Street address
School of Paramedics; Next to the Police Station to SHahroud road, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4426 4430
Fax
Email
zardoshtr911@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Ameneh Basiri
Position
Master Student Critical Care Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Next to the Police Station to SHahroud road, Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 4426 4430
Fax
Email
basiria2@mums.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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