Protocol summary

Study aim
Assessing the effect of aromatherapy (Rosa damascene essence) on the post-operative pain intensity of inguinal hernia repair
Design
Clinical trial study, randomized, double blind, duplicate and having control groups. Each group of 30 patients was designed from July to October, 2018.
Settings and conduct
The statistical population is the patients after inguinal hernia surgery in the surgical ward of Amiralmomenin Hospital in Qeydar, Iran. After surgery and transferring the patients to ward, we will measure score pain of patients by visual analog scale (VAS) within 4,8,12 hours after surgery and if pain score was upper than 3 the patients will receive rosa damascene ( experimental group ) and sweet almond oil(control group) and their score pain will be measured again and the result will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: desiring to participate in the study, having inguinal hernia surgery, not having surgery history, having full awareness and cooperation, healthy smell status, healthy visual and mind status to see and understand VAS tool, being older than 18 years old and older, being able to understand Persian or Turkish language, Not having a history of allergy to plants, not having: Pregnancy, Hypertension, Coagulation disorder, Diabetes, Breathing disorder. Not having moderate to severe anxiety and not taking analgesic and anti- anxiety drugs and no addiction. Exclusion criteria: complications of post- surgery (bleeding, hematoma at the site of surgery), need to oxygen therapy after surgery, and patient’s unwillingness to participate in the study after first intervention
Intervention groups
The patients will be randomly divided into 2 groups: the first group will inhale 40% rosa damascene essence and the second group will inhale sweet almond.
Main outcome variables
Post-operative pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140304016843N12
Registration date: 2018-07-28, 1397/05/06
Registration timing: prospective

Last update: 2018-07-28, 1397/05/06
Update count: 0
Registration date
2018-07-28, 1397/05/06
Registrant information
Name
Nasrin Bahraminejad
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 24 3314 8325
Email address
bahrami_n@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-01, 1397/05/10
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of aromatherapy (Rosa damascene essence) on the postoperative pain intensity of inguinal hernia repair
Public title
The effect of aromatherapy with Rosa damascene on post-operative pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Desiring to participate in the study Having inguinal hernia surgery Not having surgery history Having full awareness and cooperation Healthy smell status Healthy visual and mind status to see and understand VAS tool Being older than 18 years old and older Being able to understand Persian or Turkish language Not having a history of allergy to plants Not having: Pregnancy, Hypertension, Coagulation disorder, Diabetes, Breathing disorder Not having moderate to severe anxiety and not taking analgesic and anti- anxiety drugs No addiction
Exclusion criteria:
Complications of post- surgery (bleeding, hematoma at the site of surgery) Need to oxygen therapy after surgery Patient’s unwillingness to participate in the study after first intervention
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Candidate patient for inguinal hernia surgery will be selected through convenience sampling and with Block random allocation method will be applied to the case and control groups. we use of block randomization To create two identical groups, first for each of group will be allocated letters A and B. size of blocks will be foursome, After the list of all possible modes and assign a number to each one, some block will be selected through Table of random numbers until number of sample to be 60
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study patients will be informed that they will participate in study but they will not notice that they are in the case group or in the control group. Samplers will not notice that which group are the case group and which group are the control group ( materials required for intervention will be given to samplers in the form two containers with the names A and B and will not be given explanatory about content of the container for them), Also, nurses are working in the department will not be informed of the case or control groups.
Placebo
Used
Assignment
Parallel
Other design features
Experimental double blind clinical trial study

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences, Azadi blvd
City
Zanjan
Province
Zanjan
Postal code
4581955159
Approval date
2018-05-29, 1397/03/08
Ethics committee reference number
IR.ZUMS.REC.1397.20

Health conditions studied

1

Description of health condition studied
Post-operative pain
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Post-operative pain
Timepoint
In 4, 8, and 12 hours after the transfer of the patient from the operating room to the surgical unit
Method of measurement
VAS (Visual analog Scale)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: in this study, Intervention will be done in the form aromatherapy with Rosa damascene essence. After we have found that the result of skin sensitivity test for essence is negative, pain score of patient will be checked with visual analog scale (VAS) in 4,8,12 hours after surgery and if pain score of patients was upper than 3, five drops of Rosa damascene essence will be poured on cotton ball and pinned to the patient’s shirt and Patients will inhale it for 20 minutes at a distance of 20 cm, then pain score will be measured with visual analog scale again. In all three interventions, if pain score of patient after aromatherapy was upper than 3, the patients will receive routine analgesics by the staff.
Category
Treatment - Drugs

2

Description
Control group: in control group, patient will receive aromatherapy like experimental group but this group will receive Sweet Almond Oil (placebo) instead of Rosa damascene essence and pain score of patients will be measured similar to the experimental group.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Abolfazl amini
Street address
Amiralmomenin Hospital, Shafa Street
City
Qeydar
Province
Zanjan
Postal code
4581955159
Phone
+98 24 3422 1693
Email
amini.abolfazle@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Alireza Shoghli
Street address
Zanjan University of Medical Sciences, Azadi square
City
Zanjan
Province
Zanjan
Postal code
4581955159
Phone
+98 24 3315 6570
Email
amini.abolfazle@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Abolfazl Amini
Position
دانشجوی کارشناسی ارشد پرستاری داخلی جراحی
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Faculty, Mahdavi Blvd, Karmandan settlement
City
Zanjan
Province
Zanjan
Postal code
Iran
Phone
+98 24 3314 8300
Email
amini.abolfazle@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr Nasrin Bahraminejad
Position
Ph.D
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Mahdavi Blvd, Karmandan settlement
City
Zanjan
Province
Zanjan
Postal code
Iran
Phone
+98 24 3314 8325
Email
bahrami_n@zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Nasrin Bahraminejad Dr
Position
Ph.D.
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Mahdavi Blvd, Karmandan settlement
City
Zanjan
Province
Zanjan
Postal code
Iran
Phone
+98 24 3314 8325
Email
bahrami_n@zums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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