Protocol summary

Summary
The aim of this study is to investigate the effects of aromatherapy on anxiety before crusher surgery through the skin. The level of anxiety, as the main variable, will be measured using standard questionnaires before and the morning of surgery. The used aroma in the intervention group is that of roses. The study population includes all patients admitted to Jahrom Peymanieh Hospital for crusher surgery through the skin with the spinal anesthesia. People developing chronic and cancerous pain, hearing or speech loss, lack of mental health and sensitivity to roses were excluded from the study. The sample size was estimated 38 people. Prior to the surgery, patients were divided into intervention and control groups through random allocation method using random numbers table. In the control group, without any interference, anesthesia technician will get his patient to complete questionnaire the day before and the morning of surgery. In the intervention group, the technician will attend at the bedside the day before the surgery and at first get the patient to complete the questionnaire. Then the morning of surgery, he will impregnate a piece of cotton with the essence of rose 4 hours prior to surgery and will install it on the patient's clothing. The patient breathes normally during this period. After the patient’s entering to the operating room, Spielberger questionnaire will be again completed by anesthesia technicians. All patients need to have informed consent to participate in the study. It is expected that the performed intervention results in decreasing anxiety and increasing satisfaction with this non-pharmacological methods of anxiety control.

General information

Acronym
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IRCT registration information
IRCT registration number: IRCT2016020414049N3
Registration date: 2016-06-07, 1395/03/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-06-07, 1395/03/18
Registrant information
Name
Ali Abbasi Jahromi
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 79 1334 1501
Email address
abbasija@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Jahrom University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2017-12-01, 1396/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial the effect of aroma therapy on severity of anxiety in patient before crusher surgery through the skin , by spinal anesthesia compared with patients with routine care
Public title
The Effect of Aromatherapy on patient anxiety before surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: All patients who are about to undergo crusher surgery through the skin in Peymanieh Hospital affiliated with Jahrom University of Medical Sciences and spinal anesthesia can be done for them. Informed consent to participate in this study is among the main inclusion criteria. Exclusion criteria: Sensitivity to roses, education lower that primary, developing chronic and cancerous pain, hearing or speech loss, lack of mental health, chronic use of drugs and sedatives, Unstable hemodynamic status, expressed dissatisfaction to continue research.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 38
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Double blind method has been used in this study so that the 1- The volunteer and 2- The person who records anxiety are not aware of measurement methods in intervention and control group.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic Committee of Jahrom University of Medical Sciences
Street address
School of Nursing and Midwifery, Motahhari Blvd, Jahrom
City
Jahrom
Postal code
Approval date
2016-02-03, 1394/11/14
Ethics committee reference number
JUMS.Rec.1394.180

Health conditions studied

1

Description of health condition studied
The level of anxiety after Aroma Therapy
ICD-10 code
F48.8
ICD-10 code description
Other specified neurotic disorders

Primary outcomes

1

Description
Anxiety
Timepoint
before intervention and then Every 4 hours before intervention Within 24 hours(1 days)
Method of measurement
Spielberger questionnaire

Secondary outcomes

1

Description
Vital signs
Timepoint
Before surgery
Method of measurement
Monitoring Blood pressure, Heart Rate, Temperature, Breathing

Intervention groups

1

Description
In the control group, patients will receive the usual care after being admitted to the ward and anxiety will be recorded prior to the operation.
Category
N/A

2

Description
In the intervention group,Researcher will impregnate a piece of cotton with the essence of rose 4 hours prior to surgery and will install it on the patient's clothing.Then the patient breathes normally during this period. After the patient’s entering to the operating room, Spielberger questionnaire will be again completed by anesthesia technicians
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Peymanieh Hospital
Full name of responsible person
Zarean Vahid
Street address
Jahrom, Valiye Asr Street
City
Jahrom

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Jahrom University of Medical Sciences
Full name of responsible person
Solh Ju Kavos
Street address
Vice chancellor for research, Jahrom University of Medical Sciences, Motahhari Blvd, Jahrom
City
Jahrom
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, Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Zarean Vahid
Position
Anesthesia Undergraduate Student
Other areas of specialty/work
Street address
Nursing and Midwifery College, Motahhari Blvd, Jahrom
City
Jahrom
Postal code
Phone
+98 31 4585 6945
Fax
Email
vahidzaran13@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Abbasi Jahromi Ali
Position
Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Motahhari Blvd, Jahrom
City
Jahrom
Postal code
Phone
+98 7156474254600
Fax
Email
AbbasiJa@jums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Vahid Zarean
Position
Anesthesia Undergraduate Student
Other areas of specialty/work
Street address
Nursing and Midwifery College, Motahhari Blvd, Jahrom
City
Jahrom
Postal code
Phone
+98 31 4585 6945
Fax
Email
vahidzaran13@gmail.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
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