The effect of mandala coloring on the level of anxiety and physiological indicators of endoscopy candidates referring to hospitals and educational clinics affiliated to Mazandaran University of Medical Sciences in 2024
Investigating the effect of mandala coloring on anxiety and physiological indicators of endoscopy candidates
Design
The current study is a randomized clinical trial with two groups. The selection of samples in the present study will be available. 70 participants will be included in the study according to the inclusion criteria. Then they will be assigned to two intervention and control groups by random block method.
Settings and conduct
After the samples were selected in Imam Khomeini Hospital, Sari, the Spielberger anxiety questionnaire will be completed by the patient and the physiological indicators checklist will be completed by the researcher before the intervention in both groups. will be. On the day of endoscopy, Spielberger's anxiety questionnaire will be completed by both groups before the start of endoscopy, and physiological indicators will be checked and recorded. Then the data will be entered in SPSS statistical software and the results will be analyzed by statistical methods.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Patients on the list for endoscopy aged 18 to 50 years
Ability to provide informed consent
Exclusion Criteria:
History of previous endoscopy
Neurological disorders and use of psychoactive and sedative medications
Intervention groups
A booklet containing mandala designs will be provided to the entry group. The people of the intervention group will be asked to paint the mandala for 6 consecutive days and 30 minutes a day before the endoscopy. The control group will not receive the intervention during this period.
Main outcome variables
Anxiety and physiological indicators (systolic and diastolic blood pressure, breathing rate, heart rate and percentage of oxygen saturation in peripheral blood)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240723062521N2
Registration date:2024-08-14, 1403/05/24
Registration timing:prospective
Last update:2024-08-14, 1403/05/24
Update count:0
Registration date
2024-08-14, 1403/05/24
Registrant information
Name
Negar Karami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3425 8062
Email address
negarkarami88@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-05, 1403/06/15
Expected recruitment end date
2024-11-05, 1403/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mandala coloring on the level of anxiety and physiological indicators of endoscopy candidates referring to hospitals and educational clinics affiliated to Mazandaran University of Medical Sciences in 2024
Public title
The effect of mandala coloring on the level of anxiety and physiological indicators of endoscopy candidates
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to cooperate in research
Ages 18 to 50 years
The patient is on the list for endoscopy
Have the ability to color
Exclusion criteria:
Have a previous history of endoscopy
Having a history of neurological diseases and the use of psychoactive drugs (through questioning and self-reporting by the patient)
Use of benzodiazepines and sedatives during participation in a mandala coloring intervention
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Sample selection in this study will be done using a convenience sampling method. Allocation to intervention and control groups will occur based on entry criteria and the order of participant enrollment, employing a randomized block design (blocks of four) to assign participants to either the intervention group (A) or the control group (B), with a reallocation of the blocks. The randomization list for the blocks of four will be determined by a statistician and provided to the researcher.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
13th floor, block A, Treatment and Medical Education, Central headquarters of the Ministry of Health, between South Flamak and Zarafshan, Simai Iran St, Quds town (west), Tehran
City
sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Approval date
2024-07-29, 1403/05/08
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1403.027
Health conditions studied
1
Description of health condition studied
اضطراب و شاخص های فیزیولوژیک
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The first measured outcome is reduction of anxiety score in the intervention group compared to the control group.
Timepoint
In both groups, it will be done once before the intervention and once at the end of the intervention.
Method of measurement
Spielberger anxiety questionnaire
2
Description
The second outcome variable is the improvement of physiological indicators (systolic and diastolic blood pressure, breathing rate, heart rate and body temperature) in the intervention group compared to the control group.
Timepoint
In both groups, it will be done once before the intervention and once at the end of the intervention.
Method of measurement
Digital blood pressure indicator, monitoring device, counting chest movements and pulse oximeter device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, the patient is asked to color the mandala design for 30 minutes a day for 6 consecutive days before the endoscopy, and also half an hour before the endoscopy, the research units will color the mandala.
Category
Rehabilitation
2
Description
Control group: In the control group, no intervention will be performed and all routine care will be performed before the endoscopy.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Ali Rahimi
Street address
Razi St., Imam Khomeini hospital
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3335 0670
Email
emamsari.hospital@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Ali Rahimi
Street address
Mazandaran University of Medical Sciences and Health Services, the beginning of Vali Asr Highway, Joibar Street, Sari
City
Sari
Province
Mazandaran
Postal code
Phone
+98 11 3448 4800
Email
pajhoheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?