Comparing the effects of aromatherapy with Citrus aurantium and music therapy on anxiety and some of vital signs in non emergency coronary Angiography candidates.
The aim of this study is to determine the effects of aromatherapy with Citrus aurantium and music therapy on anxiety and some of vital signs in non emergency coronary Angiography candidates. This study is a clinical trial of phase 3, single-centered. 120 patients with inclusion criteria: candidates for angiography. Exclusion criteria: Severe reaction to Citrus aurantium and its flavor intolerance; Unstable patient hemodynamic status during intervention; There is a hearing impairment, smell and vision.The patients are divided into four groups of 30 people. At first, the vital signs and anxiety level of the patients are measured using an anxiety questionaire. Then, in the first group three drops of Citrus aurantium, in the second group three drops of normal saline were poured onto cotton and inhale for twenty minute. In the third group mildly instrumental music is played by headphone for twenty minute and in control group it isn't done any intervention. Twenty minutes later, the level of anxiety and vital signs are checked again and they are determine the response to treatment
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017092610222N13
Registration date:2017-09-28, 1396/07/06
Registration timing:na
Last update:
Update count:0
Registration date
2017-09-28, 1396/07/06
Registrant information
Name
Zahra Keivani
Name of organization / entity
Shahrekord University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1222 0016
Email address
keivani@skums.ac.ir
Recruitment status
Not enough for processing
Funding source
Shahrekord University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of aromatherapy with Citrus aurantium and music therapy on anxiety and some of vital signs in non emergency coronary Angiography candidates.
Public title
Comparing the effects of aromatherapy with Citrus aurantium and music therapy on anxiety and some of vital signs in non emergency Angiography candidate
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criterion: candidates for angiography.
Exclusion criteria: Severe reaction to Citrus aurantium and its flavor intolerance; Unstable patient hemodynamic status during intervention; There is a hearing impairment, smell and vision
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Kashani street, shahrekord university of medical sciences, shahrekord
City
Shahrekord
Postal code
Approval date
2017-09-24, 1396/07/02
Ethics committee reference number
IR.SKUMS.REC.196.158
Health conditions studied
1
Description of health condition studied
Coronary Angiography
ICD-10 code
Z95.5
ICD-10 code description
Presence of coronary angioplasty implant and graft
Primary outcomes
1
Description
anxiety level
Timepoint
twenty minute later
Method of measurement
questionaire
Secondary outcomes
1
Description
vital sign
Timepoint
twenty minute later
Method of measurement
heart monitoring
Intervention groups
1
Description
in the first group, three drops of Citrus aurantium were poured onto cotton and inhale for twenty minute.
Category
Treatment - Drugs
2
Description
in the second group, three drops of normal saline were poured onto cotton and inhale for twenty minute
Category
Treatment - Drugs
3
Description
In the third group mildly instrumental music is played for twenty minute by headphone.
Category
Treatment - Drugs
4
Description
in control group it isn't done any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar Hospital in Shahrekord
Full name of responsible person
Fereshte Aein
Street address
Parastar street,Hajar Hospital of Shahrekord University of Medical Sciences, shahrekord
City
shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shahrekord University of Medical Science
Full name of responsible person
Dr. Kamal Solati
Street address
Kashani street, shahrekord university of medical sciences, shahrekord
City
Shahrekord
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 of Shahrekord University of Medical Science
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
Shahrekord University of Medical Sciences
Full name of responsible person
Fereshte Aein
Position
Ph.D. in Nursing, Associate professor
Other areas of specialty/work
Street address
Rahmatie, Faculty of Nursing Midwifery ,Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3333 5652
Fax
Email
fereshtehaein@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Fereshte Aein
Position
Ph.D. in Nursing, Associate professor
Other areas of specialty/work
Street address
Rahmatie, Faculty of Nursing Midwifery ,Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 3333 5652
Fax
Email
fereshtehaein@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahrekord University of Medical
Full name of responsible person
Fereshte Aein
Position
Ph.D. in Nursing, Associate professor
Other areas of specialty/work
Street address
Rahmatie, Faculty of Nursing Midwifery ,Shahrekord University of Medical Sciences, Shahrekord
City
Shahrekord
Postal code
Phone
00
Fax
Email
fereshtehaein@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)