ARTNCT05283460
The Effect of Mandala Activity on Life Satisfaction
A study testing mandala in people with ART and Life Satisfaction, run by Munzur University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the effect of mandala activity on life satisfaction of women receiving chemotherapy for gynecological cancer. Read more about this study
- Who is it for?
- Ages 25 to 65 years, women only
- Conditions the study is for
- ART, Life Satisfaction, Gynecologic Cancer
- What is being tested?
- mandala
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 31 Dec 2021
- 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 25 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving chemotherapy
- No communication problems
- Having at least 6 months of cancer diagnosis
- Being in Stage 2 and Stage 3 of the disease
Who cannot join
- Having a medical device (IV catheter, etc.) or physical symptoms (vision problems, Parkinson's disease, etc.) that may prevent mandala drawing.
- Being in Stage 1 and Stage 4 of the disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mandala Activity on Life Satisfaction of Women Receiving Chemotherapy for Gynecological Cancer: A Randomized Controlled Study
This study aimed to determine the effect of mandala activity on life satisfaction of women receiving chemotherapy for gynecological cancer.
Read the detailed description
Data will be collected using the descriptive information form and the Life Satisfaction Scale.
- Conditions
- ART, Life Satisfaction, Gynecologic Cancer
- Being tested
- mandala
- Keywords
- Gynecologic Cancer, Life satisfaction, Mandala
- Medical subject headings
- Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mandalaBehavioural
Also called control group
The Life Satisfaction Scale was administered to patients in the control group at the first encounter (pre-test) and three weeks after the first encounter (post-test). Although the pre- and post-test treatment protocols were the same for both intervention and control groups, the only difference between their treament was the mandala activity, which was not applied to those in the control group. Patients in the control group continued their routine lives at home for three weeks. After the application, the mandala activity was applied to all patients who wanted it.
| Study group | Role | What they receive |
|---|---|---|
| mandala | Experimental | As in the case of previous studies, to prevent confusion and make the mandala drawing process easier, a few videos describing what a mandala is were shown to the patients, and information was provided. Next, each patient was given a set of felt-tip pens (in 24 different colors) and ready-to-use mandala papers, and they were asked to complete the mandala activity. The patients were given empty mandala books with enough pages for them to draw mandalas every day, they were asked to perform the mandala activity regularly in a time interval of their own choice every day, and whether they performed the activity was checked daily without them noticing (so that they would not have the feeling of being checked on or inspected). Receives: Behavioral: mandala |
| control group | No intervention | The Life Satisfaction Scale was administered to patients in the control group at the first encounter (pre-test) and three weeks after the first encounter (post-test). Although the pre- and post-test treatment protocols were the same for both intervention and control groups, the only difference between their treament was the mandala activity, which was not applied to those in the control group. Patients in the control group continued their routine lives at home for three weeks. After the application, the mandala activity was applied to all patients who wanted it. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Life satisfaction scale mean
Average score from life satisfaction scale ( Minimum score; 5, Maximum score;25)
Measured: up to 3 weeks
Secondary outcomes (1)
Life satisfaction scale mean
Average score from life satisfaction scale( Minimum score;5 , Maximum score;25)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Jun 2021
- Primary completion1 Nov 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARTStudies 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
- This study was designed as a randomized controlled prospective double-blind clinical trial.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Munzur University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nursel Alp Dal, Munzur University
- Investigators
- Nursel A Dal, Assist Prof, Principal investigator, Munzur Ünivesitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283460
- Sponsor's protocol ID
- munzur u
- Status last verified
- Mar 2022
- First submitted
- 7 Feb 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Activity on Life Satisfaction of Women Receiving Chemotherapy for Gynecological Cancer: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05283460
- Acronym / sponsor ID
- munzur u
- Conditions
- ART, Life Satisfaction, Gynecologic Cancer
- Keywords
- Gynecologic Cancer, Life satisfaction, Mandala
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Munzur UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 17 Mar 2022 (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 aimed to determine the effect of mandala activity on life satisfaction of women receiving chemotherapy for gynecological cancer.
Detailed description
Data will be collected using the descriptive information form and the Life Satisfaction Scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- This study was designed as a randomized controlled prospective double-blind clinical trial.
| Arm | Type | Receives |
|---|---|---|
| mandala | Experimental | Behavioral: mandalaAs in the case of previous studies, to prevent confusion and make the mandala drawing process easier, a few videos describing what a mandala is were shown to the patients, and information was provided. Next, each patient was given a set of felt-tip pens (in 24 different colors) and ready-to-use mandala papers, and they were asked to complete the mandala activity. The patients were given empty mandala books with enough pages for them to draw mandalas every day, they were asked to perform the mandala activity regularly in a time interval of their own choice every day, and whether they performed the activity was checked daily without them noticing (so that they would not have the feeling of being checked on or inspected). |
| control group | No intervention | –The Life Satisfaction Scale was administered to patients in the control group at the first encounter (pre-test) and three weeks after the first encounter (post-test). Although the pre- and post-test treatment protocols were the same for both intervention and control groups, the only difference between their treament was the mandala activity, which was not applied to those in the control group. Patients in the control group continued their routine lives at home for three weeks. After the application, the mandala activity was applied to all patients who wanted it. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Receiving chemotherapy
- No communication problems
- Having at least 6 months of cancer diagnosis
- Being in Stage 2 and Stage 3 of the disease
Key exclusion criteria (2 listed)
- Having a medical device (IV catheter, etc.) or physical symptoms (vision problems, Parkinson's disease, etc.) that may prevent mandala drawing.
- Being in Stage 1 and Stage 4 of the disease.
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 |
|---|---|---|
| mandalaAlso: control groupThe Life Satisfaction Scale was administered to patients in the control group at the first encounter (pre-test) and three weeks after the first encounter (post-test). Although the pre- and post-test treatment protocols were the same for both intervention and control groups, the only difference between their treament was the mandala activity, which was not applied to those in the control group. Patients in the control group continued their routine lives at home for three weeks. After the application, the mandala activity was applied to all patients who wanted it. | Behavioural | mandala |
Primary outcome
Life satisfaction scale mean
Time frame: up to 3 weeks
Average score from life satisfaction scale ( Minimum score; 5, Maximum score;25)
1 secondary outcome
Life satisfaction scale mean
Time frame: through study completion, an average of 1 year
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 31 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Nursel A Dal, Assist Prof principal investigator
Munzur Ünivesitesi
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 in people with ART and Life Satisfaction, run by Munzur University 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 4 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 31 Mar 2022. 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?
Life satisfaction scale mean (time frame: up to 3 weeks). 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 31 Mar 2022; AzTrials last refreshed its copy on 6 Nov 2026.