Comparison of the Effect of Spiritual Care and Aromatherapy on Anxiety and Sleep Pattern of Emergency referrer to Provincial Clinics
Design
Experimental group 1 received lavender extract with aromatherapy for 20 minutes with spiritual care.
In the group, 2 spiritual ritual interventions included providing short texts of the Holy Quran emphasizing patience and prayer. Next, two storybooks related to the above verses, patience and restraint will be provided.
Finally group discussion (reading the Quran and story) will be held in limited groups (about 3-5 people).
Settings and conduct
Interventions in three of the three alternate 5-day periods (couple or individual) for each of the mentioned samples will be conducted for approximately 20 minutes, with the guidance of the researcher and with the assistance of the prison cultural representatives, for each of the sample inmates at approximately 7-9 pm.
Group 3 (control group) receives only routine care in prison.
Participants/Inclusion and exclusion criteria
Men residing in prisons in Kurdistan province aged between 30 and 60 years. Has the physical and mental ability to read and write to answer questions
Intervention groups
Group 1 (Spiritual Care with Aromatherapy) and Number 2 for Group 2 (Spiritual Care) and Group 3 (Control Group)
Main outcome variables
Anxiety and sleep pattern of the study samples will be measured three times before and one month after the intervention using Spielberger Anxiety Inventory and Pittsburgh Sleep Quality Questionnaire.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191208045659N2
Registration date:2020-01-27, 1398/11/07
Registration timing:registered_while_recruiting
Last update:2020-01-27, 1398/11/07
Update count:0
Registration date
2020-01-27, 1398/11/07
Registrant information
Name
Sefollah Alaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
alaei@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-20, 1398/10/30
Expected recruitment end date
2020-07-21, 1399/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of spiritual care and aromatherapy on anxiety and sleep patterns of emergency referrers to Korsestan province prisons clinics
Public title
Comparison of the Effect of Spiritual Care and Aromatherapy on Anxiety and Sleep Pattern of Emergency referrers to Prison Clinic
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Men residing in prisons in Kurdistan province
Adequate literate, physically and mentally capable to answer the questions
No Mental Illness (Based on Documentation or Doctor's Approval)
No record of criminal problems such as murder
No history of allergies and respiratory diseases, according to the patient
No previous record of being in prison more than once
Exclusion criteria:
History of receiving painkillers and narcotic drugs 24 hours in advance
Prisoners with olfactory problems
Anxiety score less than 31 (mild anxiety)
Age
From 30 years old to 60 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are divided into three groups by simple random method. The groups are separated by giving them a random code, such as number one for group 1 (spiritual care with aromatherapy) and number two for group 2 (spiritual care) and number 2. Three will be performed for group 3 (control group).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The aforementioned proposal was submitted by the Forty-fourth Century Ethics Committee Of Semnan Uni
Street address
Semnan University of Medical Sciences, Damghan Road,
City
Semnan
Province
Semnan
Postal code
3514993437
Approval date
2019-12-16, 1398/09/25
Ethics committee reference number
IR.SEMUMS.REC.1398.238
Health conditions studied
1
Description of health condition studied
Anxiety and stress
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Anxiety
Timepoint
Anxiety will be measured three times before, immediately and one month after the intervention.
Method of measurement
Anxiety will be measured by using the Spielberger Anxiety Inventory.
2
Description
The sleep patterns
Timepoint
The sleep patterns of the study samples will be measured three times before, immediately before and one month after the intervention.
Method of measurement
The sleep patterns of the study samples will be measured by using of the Pittsburgh Sleep Quality Questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: group 1, 2 drops of lavender extract will be impregnated with 2 x 2 gas and attached to the prisoners' collar. This aromatherapy treatment was performed for 20 minutes inmates in 3 intermittent 5-day phases with spiritual care. Aromatherapy for the third stage is using a fumigation machine containing 2 liters of water and 20 drops of lavender extract.
Category
Lifestyle
2
Description
Intervention group: In group, 2 interventions included providing short texts of the Holy Qur'an that emphasized patience and prayer. It should be explained that the main focus is on the 10 verses of the Holy Quran (which have been recommended for patience and prayer). In addition, the beautiful text of the above verses will be provided to the participants and, if possible, an audio file containing the above verses will be provided. Next, two storybooks, one related to the above verses and the other a short story about patience and restraint, will be provided. In the research process, participants will be encouraged to share the story with others. To do this, meetings will be held in limited groups (about 3 to 5 people) if the conditions for spiritual intervention (reading the Quran and story) are available. It should be noted that the 3-step intervention mentioned will be performed in 3 alternate 5-day stages (couple or individual) for each of the mentioned samples. The mentioned intervention is provided for about 20 minutes under the guidance of the researcher and with the assistance of the prison cultural representatives, for each of the sample inmates at approximately 7-9 pm.
Category
Lifestyle
3
Description
Control group: Group 3 (control group) receives only routine care in prison
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Prisons in Kurdistan Province
Full name of responsible person
Milad Abdul Maleki
Street address
Km 12 Hamedan road
City
Sanandaj, Qorveh
Province
Kurdistan
Postal code
6661836915
Phone
+98 35 3523 2165
Email
abdolmalakim@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Reza Askari
Street address
Damghan Road, Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3514993437
Phone
+98 23 3365 4170
Email
asgari5000@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Milad Abdul Maleki
Position
Nursing master Graduate Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Damghan Road, Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3514993437
Phone
+98 23 3365 4170
Email
abdolmalakim@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babam Mohammadi
Position
Associate Professor of Semnan University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Damghan Road, Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3514993437
Phone
+98 23 3365 4170
Email
babamohammady2007@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Sefollah Alaei
Position
Assistant Professor Semnan University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Damghan Road, Semnan University of Medical Sciences
City
Semnan
Province
Semnan
Postal code
3514993437
Phone
+98 23 3365 4170
Email
alaei@semums.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
Yes - There is 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
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data are related to the anxiety and sleep patterns of prisoners referred to Kurdistan Prison Clinic receiving spiritual care and in the other group spiritual care with aromatherapy.
When the data will become available and for how long
Access to a portion of this information will be contain of the published articles, which will be released with the permission of the Semnan University of Medical Science and Kurdestan prisons Managers.
To whom data/document is available
Semnan University of Medical Sciences and Prisons Organization, if the article is published, everyone can access this section of information.
Under which criteria data/document could be used
Planning for improving prisoners 'health as well as conducting studies on prisoners' health
From where data/document is obtainable
Semnan University of Medical Sciences and Prisons Organization
What processes are involved for a request to access data/document
Written request to Semnan Prison Organization and Medical University