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).
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.
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.
- Conditions
- 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 group | Role | What they receive |
|---|---|---|
| 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. 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 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. 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.
Surgical Fear Scale
A low score on the surgical fear scale indicates a low level of surgical anxiety.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 May 2024
- Primary completion30 Aug 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Hip ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Seval Ulubay
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Seval Ulubay, Istanbul University - Cerrahpasa
- Investigators
- Seval ULUBAY, PHD, Principal investigator, Gazi State Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Effect of Mandala Art Therapy on Anxiety and Pain in Patients Undergoing Total Hip Replacement: A Randomized Controlled Study"
- ClinicalTrials.gov ID
- NCT06628557
- Acronym / sponsor ID
- Mandala Art
- Conditions
- Total Hip Replacement
- Keywords
- The Effect of Mandala Art Therapy, Anxiety, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Seval UlubayUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| The Effect of Mandala Art Therapy on Anxiety in Patients Undergoing Total Hip Replacement | Experimental | Other: The Effect of Mandala Art Therapy on Anxiety and Pain in PatientsBetween 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 | Experimental | Other: The Effect of Mandala Art Therapy on Anxiety and Pain in PatientsBetween 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing total hip replacement in the orthopedic surgery clinic.
- Patients aged 18 and over.
Key exclusion criteria (2 listed)
- Patients under the age of 18.
- Patients undergoing total hip replacement surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Effect of Mandala Art Therapy on Anxiety and Pain in PatientsAlso: The Effect of Mandala Art TherapyThe Effect of Mandala Art Therapy on Anxiety and Pain in Patients | Other | The Effect of Mandala Art Therapy on Anxiety in Patients Undergoing Total Hip Replacement, The Effect of Mandala Art Therapy on Pain in Patients Undergoing Total Hip Replacement |
Primary outcome
Surgical Fear Scale
Time frame: 8 weeks
A low score on the surgical fear scale indicates a low level of surgical anxiety.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Derived from this study: PubMed 42215343Ulubay 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.
Related trials for Total Hip Replacement
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
Recruiting
Intravenous Dexmedetomidine as a Perioperative Autonomic-Immune Neuromodulator
Hip Osteoarthritis
Not yet recruiting
Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty
Total Hip Arthroplasty (THA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seval ULUBAY, PHD principal investigator
Gazi State Hospital
1 site in 1 country: see every site and its status.
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.