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Total Hip ReplacementNCT06628557

The Effect of Mandala Art Therapy on Anxiety and Pain

A study testing The Effect of Mandala Art Therapy on Anxiety and Pain in Patients in people with Total Hip Replacement, run by Seval Ulubay at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Total Hip Replacement
What is being tested?
The Effect of Mandala Art Therapy on Anxiety and Pain in Patients
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2024to 30 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients undergoing total hip replacement in the orthopedic surgery clinic.
  • Patients aged 18 and over.

Who cannot join

  • Patients under the age of 18.
  • Patients undergoing total hip replacement surgery.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Seval Ulubay

    Samsun, Atakum/Samsun, 55200

Other trials in Turkey (Türkiye)

About this study

Official title: "The Effect of Mandala Art Therapy on Anxiety and Pain in Patients Undergoing Total Hip Replacement: A Randomized Controlled Study"

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.

Read the detailed description

Hip arthroplasty is recognized as an effective method for adults suffering from significant pain and limited mobility due to hip joint damage. The rapid advancements in total hip arthroplasty technology, alongside the increasing average life expectancy, highlight the importance of this procedure for patients who have undergone it. However, any surgical intervention can be traumatic for patients. Experiencing surgical trauma often leads to pain, and approximately 60-80% of individuals exhibit anxiety prior to such procedures. Factors contributing to anxiety and pain are frequently linked to a person's emotional, psychological, behavioral, and socio-cultural background. Previous studies have emphasized that anxiety and pain behaviors, which can adversely affect individuals during surgical processes, are related to the perception of pain. Effective and planned nursing care can significantly reduce pre-operative anxiety, resulting in lower levels of pain and anxiety post-surgery. In patients undergoing total hip arthroplasty, it is essential to manage post-operative acute pain effectively. Successful pain management allows patients to mobilize more quickly and reduces hospital stay durations. Severe post-operative pain can discourage patients from engaging in necessary exercises. To control this acute pain, it is often recommended to administer analgesics every 4-6 hours, based on medical advice. Regular pain assessment, establishing therapeutic communication with patients, and employing patient-controlled analgesia, along with oral analgesics, are among the most effective pain management strategies. Additionally, non-pharmacological methods are suggested as alternatives to pharmacological approaches. Mandala art therapy represents an inward journey for individuals, helping them feel empowered and extraordinary. The mandala, depicting the blossoming of a flower at its center, symbolizes the spiritual self. While representing unity, the mandala forms a pattern that transitions from the micro to the macro, symbolizing the moment of existence and life. Jung utilized mandala art as a therapeutic method and since then, it has been applied across various fields as mandala therapy. The mandala activity has been associated with positive psychological effects, such as enhancing individual awareness, boosting self-esteem, and reducing feelings of guilt . Literature suggests that engaging with mandalas fosters conscious awareness and positively contributes to individuals. This engagement helps focus attention and distances individuals from negative thoughts, thereby alleviating anxiety. While no significant differences have been observed between mandala coloring and drawing in terms of anxiety reduction, mandala coloring may be preferred in the future for its cost-effectiveness and ease of implementation for adults . One study found that engaging in mandala activities for at least 30 minutes daily significantly reduced anxiety levels in patients, offering an adjunctive treatment option. Another study emphasized that performing mandala activities with focus could positively impact psychological and emotional well-being, thereby reducing anxiety. A systematic meta-analysis indicated that mandala activities significantly and positively affect state anxiety. Reducing pain and anxiety in patients who have undergone total hip replacement will enhance patient comfort and satisfaction. Therefore, this study aims to evaluate the effects of mandala art therapy on anxiety and pain in patients undergoing total hip replacement.

Being tested
The Effect of Mandala Art Therapy on Anxiety and Pain in Patients
Keywords
The Effect of Mandala Art Therapy, Anxiety, Pain
Medical subject headings
Anxiety Disorders, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The Effect of Mandala Art Therapy on Anxiety and Pain in PatientsOther

    Also called The Effect of Mandala Art Therapy

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

Study groups in NCT06628557
Study groupRoleWhat they receive
The Effect of Mandala Art Therapy on Anxiety in Patients Undergoing Total Hip ReplacementExperimentalBetween 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.
Receives: 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 ReplacementExperimentalBetween 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.
Receives: Other: The Effect of Mandala Art Therapy on Anxiety and Pain in Patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Surgical Fear Scale

    A low score on the surgical fear scale indicates a low level of surgical anxiety.

    Measured: 8 weeks

  2. 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.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2024
  2. Study start1 May 2024
  3. Primary completion30 Aug 2024
  4. Study completion30 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06628557
Sponsor's protocol ID
Mandala Art
Status last verified
Jan 2025
First submitted
30 Sep 2024
Last updated
16 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ulubay S, Alptekin HM. The Effect of Mandala Art Therapy on Anxiety and Pain in Patients Undergoing Total Hip Arthroplasty: A Randomized Controlled Trial. Pain Manag Nurs. 2026 May 29:S1524-9042(26)00153-0. doi: 10.1016/j.pmn.2026.04.018. Online ahead of print.

    PubMed 42215343

Questions about this trial

What is this clinical trial studying?

A study testing The Effect of Mandala Art Therapy on Anxiety and Pain in Patients in people with Total Hip Replacement, run by Seval Ulubay at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical Fear Scale (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06628557, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.

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