Protocol summary

Summary
Background: Surgery can cause high levels of anxiety in patients. Preoperative anxiety can increase postoperative pain and need for postoperative analgesia, delay wound healing and increase stay in hospital. Nurses often look for ways to help control anxiety following surgery and disease. Aromatherapy is currently recognized as a complementary therapy and tool holistic nursing care in many countries that may help patients and lower their anxiety. Objective of this study is comparison the effect of Massage Aromatherapy and Inhalation Aromatherapy on the level of anxiety in preoperative patients. Methods: This research is a randomized clinical trial on 144 preoperative patients who admitted to Golestan and Imam Khomeini hospitals in Ahwaz, Iran. Patients is going to divide to four groups; first group take inhalation aromatherapy, second group take inhalation placebo, third group take massage aromatherapy and forth group take massage with almond oil. The level of anxiety will be evaluated by Spillberger questionnaire before and after intervention and vital signs will be documented.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201107227090N1
Registration date: 2011-08-21, 1390/05/30
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-08-21, 1390/05/30
Registrant information
Name
Monireh Babashahi
Name of organization / entity
Islamic Azad University of Najafabad
Country
Iran (Islamic Republic of)
Phone
+98 913 107 5944
Email address
babashahi_m@pnu.iaun.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahwaz Jundishapur University of Medical Sciences
Expected recruitment start date
2008-05-27, 1387/03/07
Expected recruitment end date
2008-09-06, 1387/06/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Massage Aromatherapy and Inhalation Aromatherapy on the level of anxiety in preoperative patients
Public title
Comparison the effect of Massage Aromatherapy and Inhalation Aromatherapy on the level of anxiety in preoperative patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: over 18 years old; getting more the 20 score from Spilburger questionnaire; hospitalizing at the night before surgery; ability to talk and understanding Persian language. Exclusion criteria: sever acute pain at the time of filling out the questioner; taking benzodiazepine; anti coagulants; analgesics opioids; history of exema and allergy to plants, migraine; chronic headache; inflammation; wound or burn in back skin; bleeding disease; acute mental illness according to physician diagnose and olfactory disorder.
Age
From 18 years old to 57 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 144
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ahwaz Jundishapur University of Medical Sciences
Street address
Golestan avenue
City
Ahwaz
Postal code
61355-45
Approval date
2008-05-27, 1387/03/07
Ethics committee reference number
8/20/1848/پ

Health conditions studied

1

Description of health condition studied
anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

Primary outcomes

1

Description
Anxiety
Timepoint
before & after intervention
Method of measurement
Spillberger questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
20 minute inhalation of handkerchief with 2 drop lavandula in Inhalation Aromatherapy group.
Category
Other

2

Description
In group of massage with almond oil, after washing and drying hands, the patients back has been massaged by the 15cc of almond oil from the last cervical vertebral to the lumbar and from the left to right posterior axillary line for 20 minutes.
Category
Other

3

Description
In massage aromatherapy group after washing and dryintg hands the patients back has been massaged by the 15cc of almond oil from the last cervical vertebral to the lumbar and from the left to right posterior axillary line for 20 minutes.
Category
Other

4

Description
20 minute inhalation handkerchief with 2 drop water in placebo group .
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Golestan and Emam khomeini hospitals of Ahwaz
Full name of responsible person
Monireh Babashahi
Street address
Medical-Surgical group, Nursing-Midwifery School, Isfahan Najafabad Islamic Azad University
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Alireza sarkaki
Street address
Vice chancellor for research, Ahwaz Jundishapur University of Medical Sciences, Golestan St.
City
Ahvaz
Grant name
u-87017
Grant code / Reference number
u-87017
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahwaz Jundishapur 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
Islamic Azad University of najafabad
Full name of responsible person
Monireh Babashahi
Position
MA-instructor
Other areas of specialty/work
Street address
Medical-Surgical group, Nursing-Midwifery School, Islamic Azad University of Najafabad, Najafabad
City
Isfahan
Postal code
8186633731
Phone
+98 913 107 5944
Fax
Email
babashahi_m@yahoo.com ; babashahi_m@pnu.iaun.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Sadighe Fayazi
Position
MA-instructor
Other areas of specialty/work
Street address
Medical-Surgical group, Nursing-Midwifery School, Ahvaz Jundishapur University of Medical Sciences, shahrak Daneshgahi
City
Ahvaz
Postal code
61355-45
Phone
+98 916 113 6441
Fax
Email
sadighe_fa@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University of Najafabad
Full name of responsible person
Monireh Babashahi
Position
MA-instructor
Other areas of specialty/work
Street address
Medical-Surgical group, Nursing-Midwifery School, Islamic Azad University of Najafabad, Najafabad
City
Isfahan
Postal code
8186633731
Phone
+98 913 107 5944
Fax
Email
babashahi_m@yahoo.com ; babashahi_m@pnu.iaun.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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