Determining the effect of mandala coloring on existential anxiety, loneliness, and spiritual health of the elderly living in nursing homes
Design
Randomized clinical trial
Settings and conduct
The current study is a randomized clinical trial study that will be conducted at the Shahrekord University of Medical Sciences in 1403. The sample will be done by simple randomization from 3 nursing homes in Shahrekord and Borujen, and participants will be randomly assigned to two test and control groups. The intervention involves the implementation of the mandala painting method over 4 weeks. Before and after the intervention, demographic and health information questionnaires, Good existential anxiety questionnaire, UCLA Loneliness Scale and spiritual health scale will be collected.
Participants/Inclusion and exclusion criteria
Being at least 60 years old- Participant's consent to participate in the research- - People who are accommodated in a nursing home (separate from their family) - Not memory impairment or Alzheimer's disease according to the hospice doctor's diagnosis and the information in the file-
Intervention groups
The researcher gives detailed verbal explanations to the elderly in the intervention group about the intervention method. Then, each elderly person is given a box of 6 colored pencils (red, orange, yellow, green, blue, and purple) and the subjects during 4 consecutive weeks, in 2 sessions per week (Saturday and Tuesday every week), mandala designs in the dimensions of A4 paper (21.0 cm x 29.7 cm) provided by the researcher in each session from simple to complex for 20 minutes from the periphery to the center of the circle for.
After the pretest, the control group will receive only routine care from the nursing home staff.
Main outcome variables
Existential anxiety, loneliness and spiritual health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240806062674N1
Registration date:2024-08-26, 1403/06/05
Registration timing:prospective
Last update:2024-08-26, 1403/06/05
Update count:0
Registration date
2024-08-26, 1403/06/05
Registrant information
Name
Farshad Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 0061
Email address
heidari.f@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-10-22, 1403/08/01
Expected recruitment end date
2025-10-23, 1404/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Coloring Mandala on Existential Anxiety, Feeling Loneliness, and Spiritual Health of the Elderly
Public title
The effect of coloring on anxiety, loneliness and spiritual health
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
- Being at least 60 years old- Participant's consent to participate in the research- - People who are accommodated in a nursing home (separate from their family) - Not having a mental or physical disability based on the file information (the elderly person has the necessary visual, hearing and movement ability)- Not memory impairment or Alzheimer's disease according to the hospice doctor's diagnosis and the information in the file- Not having acute mental disorders based on the diagnosis of the hospital doctor and file information- Non-participation in other treatment courses at the same time- Not receiving psychiatric drugs for more than two weeks before the start of the intervention based on the report of the elderly and file information- At least 3 months have passed since the elderly person was in the nursing home- Not using temporary leave for more than one week during the study period
Exclusion criteria:
- Withdrawal of participants from continuing cooperation- Death of a participant during the study period- Absence from the intervention for more than two sessions- Occurrence of any kind of serious physical and mental illness leading to hospitalization of the elderly.- Taking medication for the nerves and psyche during the implementation of the intervention- Non-participation of the elderly in the assessments before or after the intervention
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blocking of two pairs: The researcher wrote down the different conditions of the two groups (4 conditions in total: 1 control, test 2 test, control 3 test, test 4 control, control) on 5 cards each in a sealed envelope These envelopes are placed in a box and the researcher does not know which group the studied units belong to before selecting the card
By taking one of the envelopes out of the box, the researcher determines which group the two elderly people participating in the study will belong to. This process continues until all 5 cards have been removed from the box. Then the cards are put back into the box and the random selection of cards is repeated.
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
Research Ethics Committees of Shahrekord University of Medical Sciences
Street address
Kashani Blvd
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Approval date
2024-07-09, 1403/04/19
Ethics committee reference number
IR.SKUMS.REC.1403.052
Health conditions studied
1
Description of health condition studied
Elderly
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Existential Anxiety
Timepoint
Before the start of the intervention - after the end of the intervention
Method of measurement
Good Existential Anxiety Scale (EAS)
2
Description
Feeling Loneliness
Timepoint
Before the start of the intervention - after the end of the intervention
Method of measurement
UCLA Loneliness Scale
3
Description
Spiritual Health
Timepoint
Before the start of the intervention - after the end of the intervention
Method of measurement
Spiritual Health Scale (SWBS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After an online search on http://www.free-mandalas.net, the researcher selects pre-drawn mandala designs that are suitable for the elderly population. Mandalas are not so complicated but still interesting and have clear, bold lines that are easy to see and can be easily colored by older people. The intervention will be done on each of the participants in the test group individually in the consultation room of the elderly care center. The researcher gives the older people in the intervention group detailed verbal explanations about the method for carrying out the intervention. Then, each elderly person will be given a box of 6 colored pencils (red, orange, yellow, green, blue, and purple) and the subjects paint mandala designs in the dimensions of A4 paper (21.0 cm x 29.7 cm) provided by the researcher in each session from simple to complex for 20 minutes from the periphery to the center of the circle for 4 consecutive weeks in 2 sessions per week (Saturdays and Tuesdays). The individual motifs are colored freely and according to the personal ideas of the participants. Immediately after coloring the last mandala design in the eighth session, the scales of existential anxiety, loneliness, and spiritual health are evaluated by the participants.
Category
Rehabilitation
2
Description
Control group: After the pre-test, the control group will only receive routine care from the nursing home staff. In this group, the researcher will answer the subjects' questions about their state of health and the training they have received from the care staff. In this group, a post-test will be conducted after 4 weeks. The post-tests for the test and control groups will be carried out on different days. To comply with ethical considerations, the research method will be explained to the participants in the control group at the end so that they can also use this method if they wish.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahrekord nursing home
Full name of responsible person
Marzieh Borjian
Street address
،بلوار امام علی،خ هاشم مبینی،خ امام قلی جعفر زاده
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733333
Phone
+98 38 3227 5686
Email
m.borjian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr Omrani
Street address
Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 0061
Email
m.borjian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Marzieh Borjian
Position
Educator
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 0061
Email
m.borjian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Marzieh Borjian
Position
Educator
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 0061
Email
m.borjian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Farshad Heidari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahrekord University of Medical Sciences, Kashani Blvd., Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
۸۸۱۵۷۱۳۴۷۱
Phone
+98 38 3333 0061
Email
Heidari.f@skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD