Protocol summary

Summary
Objective: comparing the effect of aromatherapy with lavender oil and liquid paraffin on post dura puncture headache in patients undergoing spinal anesthesia Design: double blind randomized clinical trial Randomization: Subjects will allocate to two equal groups of control and intervention using block randomization method. Participants including major eligibility criteria: this study will conduct on 50 patients with post dura puncture headache following spinal anesthesia refer to Qom Shahid Behashti and Kamkar-Arabnia Hospital. Main inclusion criteria include having post dura puncture headache following spinal anesthesia; having no emergency conditions; lack of being in delivery or near the delivery period (until 45 days after the delivery); lack of seizures, history of migraine, tensional and other kinds of headaches, infection diseases (such as sinusitis or meningitis), intrathecal disorders, sever heart diseases and diabetes and main exclusion criteria include unwillingness for study follow-up and having nausea and vomiting or other complications due to severe headache. Main outcome: headache Intervention: Subjects in intervention group will inhale 3 drops of lavender oil 2% poured on upper lip during 15 minutes. Subjects in control group will inhale 3 drops of placebo (liquid paraffin) poured on upper lip during 15 minutes.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017051617468N3
Registration date: 2017-05-29, 1396/03/08
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-05-29, 1396/03/08
Registrant information
Name
Meysam Hoseini Amiri
Name of organization / entity
Faculty of Nursing and Midwifery, Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 0936
Email address
hoseiniam911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Qom University of Medical Sciences
Expected recruitment start date
2017-06-05, 1396/03/15
Expected recruitment end date
2018-07-21, 1397/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of aromatherapy with lavender oil on post dura puncture headache
Public title
Compassion the effect of aromatherapy with lavender oil and liquid paraffin on post dura puncture headache in patients undergoing spinal anesthesia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Having informed written consent for research participation; age of 18-60 years old; having complete consciousness; having no emergency conditions; having communication and speaking abilities; lack of being in delivery or near the delivery period (until 45 days after the delivery); having post dura puncture headache following spinal anesthesia; lack of seizures, history of migraine, tensional and other kinds of headaches, infection diseases (such as sinusitis or meningitis), intrathecal disorders, severe heart diseases and diabetes. Exclusion criteria: Unwillingness for study follow-up; having nausea and vomiting or other complications due to sever headache.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Subjects will allocate to two equal groups of control and intervention using block randomization method.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Researches of Qom University of Medical Sciences
Street address
Vice chancellor for research of Qom University of Medical Sciences, Safashar road, Qom, Iran
City
Qom
Postal code
Approval date
2017-05-02, 1396/02/12
Ethics committee reference number
IR.MUQ.REC.1396.16

Health conditions studied

1

Description of health condition studied
Headache
ICD-10 code
G44.8
ICD-10 code description
Other specified headache syndromes

Primary outcomes

1

Description
Post dura puncture headache
Timepoint
Before intervention and immediately, 30, 60, 90, and 120 minutes after the intervention
Method of measurement
Visual analog scale

Secondary outcomes

1

Description
Quality of headache
Timepoint
Immediately after intervention
Method of measurement
Modified McGill quality of pain questionnaire

Intervention groups

1

Description
Subjects in control group will inhale 3 drops of placebo (liquid paraffin) poured on upper lip during 15 minutes.
Category
Prevention

2

Description
Subjects in intervention group will inhale 3 drops of lavender oil 2% poured on upper lip during 15 minutes.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Qom Kamkar-Arabnia Hospital
Full name of responsible person
Meysam Hoseini Amiri
Street address
Qom Kamkar-Arabnia Hospital, Bjak road, Qom
City
Qom

2

Recruitment center
Name of recruitment center
Qom Shahid Behashti Hospital
Full name of responsible person
Meysam Hoseini Amiri
Street address
Qom Shahid Behashti Hospital, Shahid Behashti road, Qom
City
Qom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Qom University of Medical Sciences
Full name of responsible person
Hossein Saghafi
Street address
Vice chancellor for research of Qom University of Medical Sciences, Safashar road, Qom
City
Qom
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, Qom 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
Qom University of Medical Sciences
Full name of responsible person
Meysam Hosseini Amiri
Position
MSc of nursing
Other areas of specialty/work
Street address
Qom University of Medical Sciences, Pardisan, Qom
City
Qom
Postal code
Phone
+98 913 250 7861
Fax
Email
hoseini_amiri@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Meysam Hosseini Amiri
Position
MSc of nursing
Other areas of specialty/work
Street address
Qom University of Medical Sciences, Pardisan, Qom
City
Qom
Postal code
Phone
+98 913 250 7861
Fax
Email
hoseini_amiri@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Qom University of Medical Sciences
Full name of responsible person
Morteza Nasiri
Position
MSc of nursing
Other areas of specialty/work
Street address
Qom University of Medical Sciences, Pardisan, Qom
City
Qom
Postal code
Phone
00
Fax
Email
mortezanasiri.or87@yahoo.com
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
Loading...