NCT06628557

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 30, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

September 30, 2024

Last Update Submit

January 14, 2025

Conditions

Keywords

The Effect of Mandala Art TherapyAnxietyPain

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

EXPERIMENTAL

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.

Other: The Effect of Mandala Art Therapy on Anxiety and Pain in Patients

The Effect of Mandala Art Therapy on Pain in Patients Undergoing Total Hip Replacement

EXPERIMENTAL

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.

Other: The Effect of Mandala Art Therapy on Anxiety and Pain in Patients

Interventions

The Effect of Mandala Art Therapy on Anxiety and Pain in Patients

Also known as: The Effect of Mandala Art Therapy
The Effect of Mandala Art Therapy on Anxiety in Patients Undergoing Total Hip ReplacementThe Effect of Mandala Art Therapy on Pain in Patients Undergoing Total Hip Replacement

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Seval Ulubay

Samsun, Atakum/Samsun, 55200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety DisordersPain

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Seval ULUBAY, PHD

    Samsun Gazi State Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
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

Locations