NCT06357078

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
Last Updated

November 12, 2024

Status Verified

April 1, 2024

Enrollment Period

9 months

First QC Date

April 4, 2024

Last Update Submit

November 8, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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

    4 weeks

Study Arms (2)

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.

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.

Interventions

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.

Art Therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • No primary caregiver role
  • Has a physical disability to perform artistic practices,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neşe Uysal

Amasya, 0500, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Art Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 4, 2024

First Posted

April 10, 2024

Study Start

January 2, 2024

Primary Completion

September 30, 2024

Study Completion

October 31, 2024

Last Updated

November 12, 2024

Record last verified: 2024-04

Locations