: The effect of music therapy and aromatherapy of chamomile-lavender on fatigue and anxiety of nurses working in Besat hospital in Sanandaj in 2018
Design
The clinical trial was conducted in three groups of intervention and one control group, blind and randomized, in phase three with 120 samples.
Settings and conduct
This study will be carried out in the clinical departments of Besat Hospital in Sanandaj. The method of intervention is to include inhalation of chamomile - lavender essence and listening to music for 20 minutes during the rest of the staff in three intervention groups. There is no action in the control group. The intervention will be carried out by the first researcher collaborator. The second researcher will collect questionnaires. In this research, The second researcher and the statistical advisor will be blind to the intervention.
Participants/Inclusion and exclusion criteria
Entry criteria: Voluntary participationtudy, No thyroid dysfunction or mental illness, No anti-anxiety drugs
Exit criteria: Having allergies to the essance
Intervention groups
The first intervention group included inhalation of the essence of chamomile- lavender. The second intervention group included listens to the music. The third intervention group combined of inhalation of the essence of chamomile - lavender and listens to the music. In the control group, intervention will not be performed.
Main outcome variables
Fatigue; anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180923041106N1
Registration date:2018-11-30, 1397/09/09
Registration timing:retrospective
Last update:2018-11-30, 1397/09/09
Update count:0
Registration date
2018-11-30, 1397/09/09
Registrant information
Name
somayeh zamanifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3378 0079
Email address
zamanifar.s@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-26, 1397/07/04
Expected recruitment end date
2018-11-25, 1397/09/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of music therapy and aromatherapy of chamomile-lavender on fatigue and anxiety of nurses working in Besat hospital of Sanandaj in 2018
Public title
The effect of music therapy and aromatherapy of chamomile-lavender on fatigue and anxiety
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Voluntary participation in the study
Not being in critical condition
No thyroid dysfunction or mental illness such as anxiety
Not taking any anxiety and analgesics during the study
Have at least 6 months of work experience
Not having any history of life events and crises in the last 6 months
Have a sense of smell
Absence of respiratory diseases, asthma and allergic diseases
Non pregnancy, breastfeeding
Having a working shift
No vacation or sick leave during the study
Earn at least a score of 8 from the Beck Anxiety Inventory
No perfume in the day of study
Interest in listening to music
Exclusion criteria:
Having allergies
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, Stratified randomization will be used. Randomization is done particularly in each hospital ward as a Stratify. Considering having ten clinical wards as ten stratifies and a sample size of 120 samples, 12samples were considered from each Stratify. Randomized allocation of samples to groups in each Stratify will be applied based on lottery cards numbered 1 to 4 (for each group of three cards) without replacement of cards.assigned to each group and 12 will be allocated to four groups based on each other. From these quotas assigned in each category based on the draw of random numbers, One to four (number of groups) without substitution in each section will be assigned randomly to the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The method of blindness in this study is that the second-degree fellow will not be aware of the type of intervention. The first research partner in each of the three intervention groups will take the necessary interventions. The coding of the questionnaire and information registration forms based on the number assigned to the random sampling will be the responsibility of the main investigator. The second collaborator of the research after the end of the interventions, without considering and informing the groups, will refer to the samples for collecting the data based on this code and will be blind to the type of intervention. Also, all questionnaires will be given to the statistical consultant by the original researcher based on the coding, so the statistician will also be blind to the type of intervention.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences, after Qods Hospital
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Approval date
2018-09-04, 1397/06/13
Ethics committee reference number
IR.MUK.REC.1397.102
Health conditions studied
1
Description of health condition studied
Fatigue and anxiety
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Fatigue severity
Timepoint
Before the intervention and after three shifts
Method of measurement
Krupp Fatigue Severity Scale et al
2
Description
Anxiety
Timepoint
Before the intervention and after three shifts
Method of measurement
Beck anxiety inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: In the first intervention group, the aroma of chamomile-lavender will be used. The aroma of this research will be used the combination of lavender-chamomile 1.5% by inhalation breathing. Chamomile and lavender plants will be provided by Zardvand Pharmaceutical Company. Then, Shahid Beheshti Pharmaceutical Faculty will then extract it by distillation with water, after which it will be diluted 5% in the sesame oil base. This essential oil is prepared for each sample of three drops on a pre-prepared non-absorbent pad and will be inhaled at a distance of 20 cm from the nose for 20 minutes at rest.
Category
Prevention
2
Description
Intervention group 2: In the second intervention group, music therapy will be performed. In the music band, the intervention will be such that pre-designated music (traditional, pop, classical) will be selected as desired. Headphones will be used to play music. Music will be played for 20 minutes each time. This intervention will be performed over three consecutive shifts.
Category
Prevention
3
Description
Intervention Group 3: For nurses in this group simultaneously inhale the scent of Lavender Chamomile and listen to the desired music. Three drops of lavender chamomile will be prepared on one and a half percent on a pre-prepared, Non-absorbent pad. It will be inhaled at 20 cm from the nose for 20 minutes. From pre-set music (traditional, pop, classical), samples will be played back for 20 minutes. This intervention will be performed over three consecutive shifts
Category
Prevention
4
Description
Control group: Due to the fact that the samples are not sick and nursing, They do not receive any special treatment. Therefore, There is no specific action in the control group, but ethically, After the end of the study, The interventions will be done for the control group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Somayeh Zamanifar
Street address
Besat Hospital, Keshavarz Street, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6619616776
Phone
+98 87 3328 5910
Fax
+98 87 3366 3905
Email
zamanifarnursing@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Farzin Rezaee
Street address
Vice Chancellor for research and technology of Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
13446-66177
Phone
+98 87 3182 7464
Fax
+98 87 3336 6095
Email
zamanifarnursing@gmail.com
Grant name
Vice Chancellor for research and technology of Kurdistan University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Somayeh Zamanifar
Position
Nurse/MS.C
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Besat Hospital, Keshavarz Street , sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6619616776
Phone
+98 878733285910
Email
zamanifarnursing@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Jamal Siedi
Position
Ph.D, Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
13446-66177
Phone
+98 87 3182 7464
Fax
+98 87 3336 6095
Email
jamal.seidi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Jamal Seidi
Position
Ph.D/Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kurdistan University of Medical Sciences, after Qods Hospital, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
13446-66177
Phone
+98 87 3182 7464
Fax
+98 87 3336 6095
Email
jamal.seidi@yahoo.com
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