Palliative CareMANDALAPLİCNCT06132022
The Effect of Mandala Application on Anxiety Level and Caregiver Burden in Palliative Care
A study testing Mandala and Routine care in people with Palliative Care and Caregiver, run by Bartın Unıversity at 1 site in Turkey (Türkiye).
Trial summary
The caregivers of palliative care patients can also be negatively affected during the palliative care process. Especially family caregivers may experience difficulties in physical, social, economic, and psychological aspects. Non-pharmacological approaches are utilized to cope with these difficulties. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Palliative Care, Caregiver, Anxiety
- What is being tested?
- Mandala and Routine care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 May 2023to 15 Feb 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- have reached the age of 18
- Willingness to participate in the study
- Being able to read and write
- Having no problems in verbal communication
- Providing free care
Who cannot join
- Providing paid care
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Atlas University
Istanbul, Kağıthane, 34000
About this study
Official title: The Effect of Mandala Application on Anxiety Level and Caregiver Burden in Palliative Caregivers: A Randomized Controlled Trial
The caregivers of palliative care patients can also be negatively affected during the palliative care process. Especially family caregivers may experience difficulties in physical, social, economic, and psychological aspects. Non-pharmacological approaches are utilized to cope with these difficulties. The mandala study is one of the non-pharmacological approaches and has been utilized to support patients and caregivers in various illnesses. Mandala is a method that anyone can apply, based on coloring circular patterns. Recent studies have reported that mandala contributes to improving psychological and physiological well-being. This study is designed in a randomized controlled design to examine the effects of mandala application on anxiety levels and caregiver burden in palliative care caregivers. Caregivers who meet the inclusion and exclusion criteria will be randomly assigned to two groups using a computer program. Both groups of caregivers will be administered an information form, the STAI XT-1 State-Trait Anxiety Inventory, and the Zarit Burden Interview Scale. Then, the intervention group will be asked to apply mandala twice a week for 30 minutes for one month. After one month, the scales will be administered again. The caregivers in the control group will not receive any intervention, and after one month, the scales will be administered, and mandala application will be suggested. According to G Power analysis, with a Type I error (α) of 0.05 and a power (1-β) of 0.80, the minimum sample size that will meet the requirements is determined to be a total of 86 individuals (experimental: 43, control: 43). Considering potential sample loss, the aim is to reach 45 participants in each group. The statistical analysis of the data will be performed using SPSS version 22.0. Descriptive statistics such as frequency, median, standard deviation, mean, minimum, maximum, percentage, Kolmogorov-Smirnov test for normal distribution (N>30), skewness, and kurtosis will be used for sociodemographic characteristics. Correlation tests will be used for scale relationships, and ANOVA, Kruskal-Wallis, t-test, or Mann-Whitney U test and post-hoc tests will be used for scale comparisons according to independent variables. The significance level will be accepted as p<0.05.
- Conditions
- Palliative Care, Caregiver, Anxiety, Mandala, Caregiver Burden
- Being tested
- Mandala, Routine care
- Medical subject headings
- Anxiety Disorders, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MandalaOther
Mandala work is one of the non-pharmacological approaches and is used to support patients and caregivers in various diseases. Mandala is a method that anyone can apply based on coloring a circular shape.
Routine careOther
The clinic's routine information will be given to the caregivers of the control group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will be asked to practice the mandala twice a week, for 30 minutes, for a month. At the end of one month, the scales will be applied again. Receives: Other: Mandala |
| Control group | Placebo comparator | Caregivers in the control group will not take any action, and at the end of one month, after the scales have been applied, they will be offered mandala applications. Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
STAI XT-1 State-Trait Anxiety Scale
score anxiety: While the state anxiety scale shows the level of anxiety in a certain situation, the trait anxiety scale evaluates the level of anxiety experienced by the individual regardless of the situation. Scores on both scales range between 20 and 80. High scores indicate high anxiety level, low scores indicate low anxiety level.
Measured: 4 weeks
Zarit Care Burden Scale
Care Burden Scale: The scale, which can be completed by asking the caregivers themselves or the researcher, consists of 22 statements that determine the impact of caregiving on the individual's life. With this, the caregiver/patient relationship, the caregiver's health status, psychological comfort, social life and economic burden can be evaluated. The evaluation of scale, in which all items are clearly stated, is made on the basis of the total score. As the score increases, the burden of care also increases and a maximum score of 88 is obtained from the scale. Points obtained; It was evaluated by grading as (0-20) little/no burden, (21-40) moderate burden, (41-60) severe burden and (61-88) extreme burden.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start31 May 2023
- Primary completion15 Feb 2024
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Rondomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bartın Unıversity
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Necmiye ÇÖMLEKÇİ, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132022
- Sponsor's protocol ID
- 27042
- Acronym
- MANDALAPLİC
- Status last verified
- Jun 2024
- First submitted
- 30 May 2023
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will be stored in flash memory and shared with other researchers when necessary.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Application on Anxiety Level and Caregiver Burden in Palliative Caregivers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06132022
- Acronym / sponsor ID
- MANDALAPLİC / 27042
- Conditions
- Palliative Care, Caregiver, Anxiety, Mandala, Caregiver Burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Bartın UnıversityUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 15 Feb 2024 (actual)
- First posted
- 15 Nov 2023 (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.
The caregivers of palliative care patients can also be negatively affected during the palliative care process. Especially family caregivers may experience difficulties in physical, social, economic, and psychological aspects. Non-pharmacological approaches are utilized to cope with these difficulties. The mandala study is one of the non-pharmacological approaches and has been utilized to support patients and caregivers in various illnesses. Mandala is a method that anyone can apply, based on coloring circular patterns. Recent studies have reported that mandala contributes to improving psychological and physiological well-being. This study is designed in a randomized controlled design to examine the effects of mandala application on anxiety levels and caregiver burden in palliative care caregivers. Caregivers who meet the inclusion and exclusion criteria will be randomly assigned to two groups using a computer program. Both groups of caregivers will be administered an information form, the STAI XT-1 State-Trait Anxiety Inventory, and the Zarit Burden Interview Scale. Then, the intervention group will be asked to apply mandala twice a week for 30 minutes for one month. After one month, the scales will be administered again. The caregivers in the control group will not receive any intervention, and after one month, the scales will be administered, and mandala application will be suggested. According to G Power analysis, with a Type I error (α) of 0.05 and a power (1-β) of 0.80, the minimum sample size that will meet the requirements is determined to be a total of 86 individuals (experimental: 43, control: 43). Considering potential sample loss, the aim is to reach 45 participants in each group. The statistical analysis of the data will be performed using SPSS version 22.0. Descriptive statistics such as frequency, median, standard deviation, mean, minimum, maximum, percentage, Kolmogorov-Smirnov test for normal distribution (N>30), skewness, and kurtosis will be used for sociodemographic characteristics. Correlation tests will be used for scale relationships, and ANOVA, Kruskal-Wallis, t-test, or Mann-Whitney U test and post-hoc tests will be used for scale comparisons according to independent variables. The significance level will be accepted as p<0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Rondomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: MandalaThe intervention group will be asked to practice the mandala twice a week, for 30 minutes, for a month. At the end of one month, the scales will be applied again. |
| Control group | Placebo comparator | Other: Routine careCaregivers in the control group will not take any action, and at the end of one month, after the scales have been applied, they will be offered mandala applications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- have reached the age of 18
- Willingness to participate in the study
- Being able to read and write
- Having no problems in verbal communication
- Providing free care
Key exclusion criteria (1 listed)
- Providing paid care
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 |
|---|---|---|
| MandalaMandala work is one of the non-pharmacological approaches and is used to support patients and caregivers in various diseases. Mandala is a method that anyone can apply based on coloring a circular shape. | Other | Intervention group |
| Routine careThe clinic's routine information will be given to the caregivers of the control group. | Other | Control group |
Primary outcome
STAI XT-1 State-Trait Anxiety Scale
Time frame: 4 weeks
score anxiety: While the state anxiety scale shows the level of anxiety in a certain situation, the trait anxiety scale evaluates the level of anxiety experienced by the individual regardless of the situation. Scores on both scales range between 20 and 80. High scores indicate high anxiety level, low scores indicate low anxiety level.
Zarit Care Burden Scale
Time frame: 4 weeks
Care Burden Scale: The scale, which can be completed by asking the caregivers themselves or the researcher, consists of 22 statements that determine the impact of caregiving on the individual's life. With this, the caregiver/patient relationship, the caregiver's health status, psychological comfort, social life and economic burden can be evaluated. The evaluation of scale, in which all items are clearly stated, is made on the basis of the total score. As the score increases, the burden of care also increases and a maximum score of 88 is obtained from the scale. Points obtained; It was evaluated by grading as (0-20) little/no burden, (21-40) moderate burden, (41-60) severe burden and (61-88) extreme burden.
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 18 Jun 2024.
- Individual participant dataSharing planned: No. The data will be stored in flash memory and shared with other researchers when necessary.
Related trials for Palliative Care
Not yet recruitingObservational study
IN-TALK: Co-producing a Hospice Intimacy Support Toolkit in England
Communication About Intimacy Needs in Hospice and Palliative Care
Not yet recruitingPhase 2
Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
RecruitingPhase 1/2
Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction
Malignant Solid Neoplasm
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
Not yet recruiting
Comparing Radiotherapy Dose Strategies for Symptom Relief in Large Solid Tumors
Solid Tumor
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandala and Routine care in people with Palliative Care and Caregiver, run by Bartın Unıversity 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 5 inclusion and 1 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 18 Jun 2024. 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. Some participants in this study may receive a placebo. 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?
STAI XT-1 State-Trait Anxiety Scale (time frame: 4 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?
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 18 Jun 2024.