The Effect of Mandala Art Therapy on Anxiety and Pain
"The Effect of Mandala Art Therapy on Anxiety and Pain in Patients Undergoing Total Hip Replacement: A Randomized Controlled Study"
1 other identifier
interventional
84
1 country
1
Brief Summary
This study aims to evaluate the effects of mandala art therapy on anxiety and pain in patients undergoing total hip replacement. The data obtained from the research is expected to provide evidence regarding the impact of mandala art therapy, a non-pharmacological approach, on anxiety and pain levels in post-operative patients who have undergone total hip replacement.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2024
CompletedFirst Submitted
Initial submission to the registry
September 30, 2024
CompletedFirst Posted
Study publicly available on registry
October 8, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedJanuary 16, 2025
January 1, 2025
4 months
September 30, 2024
January 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Surgical Fear Scale
A low score on the surgical fear scale indicates a low level of surgical anxiety.
8 weeks
Visual Analog Scale (VAS)
It is displayed on a straight line between 0 and 10. As the numerical value increases, so does the stress level.
8 weeks
Study Arms (2)
The Effect of Mandala Art Therapy on Anxiety in Patients Undergoing Total Hip Replacement
EXPERIMENTALBetween May 22, 2024, and December 30, 2024, patients undergoing total hip replacement surgery at Samsun Gazi State Hospital's Orthopedic Surgery Clinic will be informed about the study. Between May 22, 2024, and December 30, 2024, patients undergoing total hip replacement surgery at Samsun Gazi State Hospital's Orthopedic Surgery Clinic will be informed about the study. Those who agree to participate will complete an Informed Consent Form, Patient Introduction Form, Pain Assessment Scale, and State-Trait Anxiety Inventory (STAI-I). One group will engage in mandala coloring activities using a coloring book on the second day post-surgery, while the other group will not receive this intervention. The same questionnaires will be administered again after the intervention. Data Analysis Data evaluation will utilize frequency, percentage, mean, standard deviation, Student's t-test, analysis of variance, and Pearson correlation analysis.
The Effect of Mandala Art Therapy on Pain in Patients Undergoing Total Hip Replacement
EXPERIMENTALBetween May 22, 2024, and December 30, 2024, patients undergoing total hip replacement surgery at Samsun Gazi State Hospital's Orthopedic Surgery Clinic will be informed about the study. Between May 22, 2024, and December 30, 2024, patients undergoing total hip replacement surgery at Samsun Gazi State Hospital's Orthopedic Surgery Clinic will be informed about the study. Those who agree to participate will complete an Informed Consent Form, Patient Introduction Form, Pain Assessment Scale, and State-Trait Anxiety Inventory (STAI-I). One group will engage in mandala coloring activities using a coloring book on the second day post-surgery, while the other group will not receive this intervention. The same questionnaires will be administered again after the intervention. Data Analysis Data evaluation will utilize frequency, percentage, mean, standard deviation, Student's t-test, analysis of variance, and Pearson correlation analysis.
Interventions
The Effect of Mandala Art Therapy on Anxiety and Pain in Patients
Eligibility Criteria
You may qualify if:
- Patients undergoing total hip replacement in the orthopedic surgery clinic.
- Patients aged 18 and over.
You may not qualify if:
- Patients under the age of 18.
- Patients undergoing total hip replacement surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seval Ulubaylead
Study Sites (1)
Seval Ulubay
Samsun, Atakum/Samsun, 55200, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seval ULUBAY, PHD
Samsun Gazi State Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
September 30, 2024
First Posted
October 8, 2024
Study Start
May 1, 2024
Primary Completion
August 30, 2024
Study Completion
December 30, 2024
Last Updated
January 16, 2025
Record last verified: 2025-01