Caregiver Stress SyndromeNCT06357078
Art Therapy and Caregivers Stress
A study testing Art Therapy in people with Caregiver Stress Syndrome, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
This research will be conducted to determine the effect of art therapy on the stress, anxiety and well-being of caregivers in the palliative care service. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Caregiver Stress Syndrome
- What is being tested?
- Art Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2024to 31 Oct 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The age of 18 and over,
- Must be able to read and speak Turkish
- Care givers of patients hospitalized in palliative care clinics,
- Has a distress score of 4 or above,
- Does not have any sensory or cognitive health problems that would prevent communication,
- Must agree to participate in the study
Who cannot join
- No primary caregiver role
- Has a physical disability to perform artistic practices,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Art Therapy in Reducing Stress and Anxiety of Caregivers
This research will be conducted to determine the effect of art therapy on the stress, anxiety and well-being of caregivers in the palliative care service.
Read the detailed description
Introduction and aim: Evidence for the use of art in health promotion has been increasing in recent years. However, in the literature review, no study was found in our country examining the effect of art therapy on caregivers. In palliative care, the management of psychological problems such as stress and anxiety that caregivers frequently experience is very important for the health and quality of life of both the patient and the caregiver. Accordingly, this research will be conducted to determine the effect of art therapy on the stress, anxiety and well-being of caregivers in the palliative care service.
Methods: The research will be carried out as a randomized controlled experimental study in the palliative care unit of a training and research hospital. A distress thermometer will be applied to individuals who are primary caregivers of patients hospitalized in the palliative care unit, and caregivers with a stress score of 4 and above will be included in the sample. The block randomization method will be used in assigning the individuals included in the sample to the art therapy and control groups. Caregivers in the art therapy group will be given art therapy practices, lasting approximately 45 minutes-1 hour, twice a week for 4 weeks. Visual and handicraft practices (painting work, collage work, mandala work, painting with felt, clay work, painting and storytelling) are done in art therapy activities that will last for 4 weeks, and it is aimed to develop personal and emotional awareness, reduce stress and increase general well-being. Research data will be collected using Descriptive Information Form, Distress Thermometer, State Anxiety Inventory and Personal Well-Being Scale.
Conclusions: It is thought that this study will increase attention to art therapy, improve stress and anxiety levels in caregivers, and strengthen current and future research in art therapy and nursing research. Given the key role caregivers play in palliative care, it is important to support caregivers as a necessity for holistic and comprehensive health care services
- Conditions
- Caregiver Stress Syndrome
- Being tested
- Art Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art TherapyOther
Caregivers in the art therapy group will be given art therapy practices, lasting approximately 45 minutes-1 hour, twice a week for 4 weeks. Visual and handicraft practices (painting work, collage work, mandala work, painting with felt, clay work, painting and storytelling) are done in art therapy activities that will last for 4 weeks, and it is aimed to develop personal and emotional awareness, reduce stress and increase general well-being.
| Study group | Role | What they receive |
|---|---|---|
| Art Therapy | Experimental | Caregivers in the art therapy group will be given art therapy practices, lasting approximately 45 minutes-1 hour, twice a week for 4 weeks. Visual and handicraft practices (painting work, collage work, mandala work, painting with felt, clay work, painting and storytelling) are done in art therapy activities that will last for 4 weeks, and it is aimed to develop personal and emotional awareness, reduce stress and increase general well-being. Receives: Other: Art Therapy |
| Control | No intervention | No intervention will be applied to the patients in the control group during the follow-up period, only data collection forms will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distress Thermometer
Distress Thermometer: Distress Thermometer is a Likert-type scale with scores from 0 (no stress) to 10 (extreme stress) and was developed to determine psychological distress. With the scale, which is short and easy to understand, individuals can easily mark their own stress levels within the ranges specified on the thermometer. The recommended cut-off point for the stress thermometer is 4 and above, and a score of 4 and above indicates the presence of stress.
Measured: 4 weeks
The State Anxiety Inventory
The State Anxiety Inventory is a tool that is sensitive to affective, physiological and cognitive processes such as anxiety, anxiety and excitement, and is very sensitive to sudden changing reactions. There are reverse coded expressions in the scale (items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20). In evaluating the scale scores, after finding the separate total weights of the direct and reverse expressions, the total weight score of the reverse expressions is subtracted from the total weight score obtained for the direct expressions, and a predetermined, unchanging value is added to this number. The last value obtained is the individual's anxiety score. The total score obtained from the scale varies between 20-80, a high score indicates a high level of anxiety, and a low score indicates a low level of anxiety
Measured: 4 weeks
Personal Well-Being Index
Personal Well-Being Index is a scale that measures happiness and well-being in individuals' lives. It is a thematic and 11-point Likert type (0: I am completely dissatisfied-5: I am neutral-10: I am completely satisfied) measurement tool that aims to measure individuals' satisfaction levels with eight living areas. The eight life domains are listed as personal health, success in life, personal relationships, personal security, social bond/belonging, standard of living, future certainty, and spirituality/religion. The scale includes a single question for each of the eight life domains. The lowest score that can be obtained from the scale is 0 and the highest score is 80. A high score from the scale indicates a high perception of personal well-being
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 posted10 Apr 2024
- Study start2 Jan 2024
- Primary completion30 Sep 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver Stress SyndromeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neşe Uysal, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357078
- Sponsor's protocol ID
- AmasyaU-NU-679
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Art Therapy in Reducing Stress and Anxiety of Caregivers
- ClinicalTrials.gov ID
- NCT06357078
- Acronym / sponsor ID
- AmasyaU-NU-679
- Conditions
- Caregiver Stress Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 10 Apr 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 research will be conducted to determine the effect of art therapy on the stress, anxiety and well-being of caregivers in the palliative care service.
Detailed description
Introduction and aim: Evidence for the use of art in health promotion has been increasing in recent years. However, in the literature review, no study was found in our country examining the effect of art therapy on caregivers. In palliative care, the management of psychological problems such as stress and anxiety that caregivers frequently experience is very important for the health and quality of life of both the patient and the caregiver. Accordingly, this research will be conducted to determine the effect of art therapy on the stress, anxiety and well-being of caregivers in the palliative care service.
Methods: The research will be carried out as a randomized controlled experimental study in the palliative care unit of a training and research hospital. A distress thermometer will be applied to individuals who are primary caregivers of patients hospitalized in the palliative care unit, and caregivers with a stress score of 4 and above will be included in the sample. The block randomization method will be used in assigning the individuals included in the sample to the art therapy and control groups. Caregivers in the art therapy group will be given art therapy practices, lasting approximately 45 minutes-1 hour, twice a week for 4 weeks. Visual and handicraft practices (painting work, collage work, mandala work, painting with felt, clay work, painting and storytelling) are done in art therapy activities that will last for 4 weeks, and it is aimed to develop personal and emotional awareness, reduce stress and increase general well-being. Research data will be collected using Descriptive Information Form, Distress Thermometer, State Anxiety Inventory and Personal Well-Being Scale.
Conclusions: It is thought that this study will increase attention to art therapy, improve stress and anxiety levels in caregivers, and strengthen current and future research in art therapy and nursing research. Given the key role caregivers play in palliative care, it is important to support caregivers as a necessity for holistic and comprehensive health care services
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Art Therapy | Experimental | Other: Art TherapyCaregivers in the art therapy group will be given art therapy practices, lasting approximately 45 minutes-1 hour, twice a week for 4 weeks. Visual and handicraft practices (painting work, collage work, mandala work, painting with felt, clay work, painting and storytelling) are done in art therapy activities that will last for 4 weeks, and it is aimed to develop personal and emotional awareness, reduce stress and increase general well-being. |
| Control | No intervention | –No intervention will be applied to the patients in the control group during the follow-up period, only data collection forms will be applied. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The age of 18 and over,
- Must be able to read and speak Turkish
- Care givers of patients hospitalized in palliative care clinics,
- Has a distress score of 4 or above,
- Does not have any sensory or cognitive health problems that would prevent communication,
Key exclusion criteria (2 listed)
- No primary caregiver role
- Has a physical disability to perform artistic practices,
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 |
|---|---|---|
| Art TherapyCaregivers in the art therapy group will be given art therapy practices, lasting approximately 45 minutes-1 hour, twice a week for 4 weeks. Visual and handicraft practices (painting work, collage work, mandala work, painting with felt, clay work, painting and storytelling) are done in art therapy activities that will last for 4 weeks, and it is aimed to develop personal and emotional awareness, reduce stress and increase general well-being. | Other | Art Therapy |
Primary outcome
Distress Thermometer
Time frame: 4 weeks
Distress Thermometer: Distress Thermometer is a Likert-type scale with scores from 0 (no stress) to 10 (extreme stress) and was developed to determine psychological distress. With the scale, which is short and easy to understand, individuals can easily mark their own stress levels within the ranges specified on the thermometer. The recommended cut-off point for the stress thermometer is 4 and above, and a score of 4 and above indicates the presence of stress.
The State Anxiety Inventory
Time frame: 4 weeks
The State Anxiety Inventory is a tool that is sensitive to affective, physiological and cognitive processes such as anxiety, anxiety and excitement, and is very sensitive to sudden changing reactions. There are reverse coded expressions in the scale (items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20). In evaluating the scale scores, after finding the separate total weights of the direct and reverse expressions, the total weight score of the reverse expressions is subtracted from the total weight score obtained for the direct expressions, and a predetermined, unchanging value is added to this number. The last value obtained is the individual's anxiety score. The total score obtained from the scale varies between 20-80, a high score indicates a high level of anxiety, and a low score indicates a low level of anxiety
Personal Well-Being Index
Time frame: 4 weeks
Personal Well-Being Index is a scale that measures happiness and well-being in individuals' lives. It is a thematic and 11-point Likert type (0: I am completely dissatisfied-5: I am neutral-10: I am completely satisfied) measurement tool that aims to measure individuals' satisfaction levels with eight living areas. The eight life domains are listed as personal health, success in life, personal relationships, personal security, social bond/belonging, standard of living, future certainty, and spirituality/religion. The scale includes a single question for each of the eight life domains. The lowest score that can be obtained from the scale is 0 and the highest score is 80. A high score from the scale indicates a high perception of personal well-being
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 12 Nov 2024.
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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.
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 Art Therapy in people with Caregiver Stress Syndrome, run by Amasya 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 6 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 12 Nov 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. 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?
Distress Thermometer (time frame: 4 weeks). The study lists 3 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 12 Nov 2024.