- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06628557
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"
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Atakum/Samsun
-
Samsun, Atakum/Samsun, Turkey, 55200
- Seval Ulubay
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients undergoing total hip replacement in the orthopedic surgery clinic.
- Patients aged 18 and over.
Exclusion Criteria:
- Patients under the age of 18.
- Patients undergoing total hip replacement surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The Effect of Mandala Art Therapy on Anxiety in Patients Undergoing Total Hip Replacement
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. 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 Anxiety and Pain in Patients
Other Names:
|
|
Experimental: The Effect of Mandala Art Therapy on Pain in Patients Undergoing Total Hip Replacement
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. 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 Anxiety and Pain in Patients
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgical Fear Scale
Time Frame: 8 weeks
|
A low score on the surgical fear scale indicates a low level of surgical anxiety.
|
8 weeks
|
|
Visual Analog Scale (VAS)
Time Frame: 8 weeks
|
It is displayed on a straight line between 0 and 10.
As the numerical value increases, so does the stress level.
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: SEVAL ULUBAY, PHD, Samsun Gazi State Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Mandala Art
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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