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The Effect of Art Therapy on Pain, Emesis, Anxiety and Quality of Life, Breast Cancer

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Art therapy
Sponsored by
Cumhuriyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast cancer,, art therapy, marbling art, music therapy, pain,, emesis,, anxiety, quality of life

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients who have received at least one course of chemotherapy, who have undergone breast surgery, who have not been given art therapy, who have no communication difficulties and no mental problems, who are 18 years of age or older, and who agreed to participate in the study. Exclusion Criteria: Those with cancer stage IV, visual, hearing and communication difficulties, those under the age of 18 and those who wanted to leave the study were not included in the study.

Sites / Locations

  • Esra BAŞER AKIN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention Group

Control Group

Arm Description

Within the scope of the research, the art of marbling was made by the art expert, accompanied by a total of 5 sessions ney concerts for 10 weeks, with two-week intervals. The art application was made to last 20-30 minutes before the patients received chemotherapy. The scales were administered to the individuals in the intervention groups three times in total.

No treatment was applied to the control group. The scales were administered to the individuals in the control groups three times in total.

Outcomes

Primary Outcome Measures

Visual Analog Scale:
It is a scale used to evaluate the pain experienced by patients. Scale; It contains the numbers "start 0 (no pain)" and "10 (severe pain)" at the other end. The patient marks the level of pain he experiences based on these two values.
The Rhodes index of nausea, vomiting and retching (RINVR)
They found that the alpha internal consistency coefficient of the Nausea, Vomiting and Regurgitation Index, developed by Rhodes and McDaniel and validity and reliability by Rhodes and McDaniel, ranged from 0.98, and the alpha internal consistency coefficients of the subgroups ranged between 0.83 and 0.99. Each response is scored as 0 = least distress, 4 = most distress. The patient's experience of nausea and vomiting in each of the 8 items is summed up. The highest possible value is 32 and represents the most severe symptom occurrence score.It was adapted to Turkish society by Tan and Genç (2010).
Beck Anxiety Scale (BAI)
Beck et al. (1988) in order to determine the frequency of anxiety symptoms experienced by the individual. The scale is a Likert-type self-assessment scale consisting of 21 items and scored between 0-3. The high total score indicates the high level of anxiety experienced by the person. The score range ranges from 0 to 63. Evaluation of the scale is 0-7 points for no anxiety symptoms, 8-15 for mild anxiety, 16-25 for moderate anxiety, and 26-63 for severe anxiety symptoms.
FACT-G Quality of Life Scale
FACT-G is a quality of life scale. In the Turkish naming of this scale, the abbreviation of the original scale [Functional Assessment of Cancer Therapy- General] (FACT-G) is used. It was developed by Cella et al. in 1993. The Turkish validity and reliability of the scale were performed by Çetiner et al. in 2004. This scale has 4 subgroups consisting of 28 items: physical condition, social life and family status, activity status and emotional state. Total scale score is obtained by summing the scores of all items and subgroup scores are obtained by summing the scores of the items in the subgroup. High scores on the total scale and subgroups suggest that patients' quality of life is also high.

Secondary Outcome Measures

Full Information

First Posted
December 9, 2022
Last Updated
December 28, 2022
Sponsor
Cumhuriyet University
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1. Study Identification

Unique Protocol Identification Number
NCT05666583
Brief Title
The Effect of Art Therapy on Pain, Emesis, Anxiety and Quality of Life, Breast Cancer
Official Title
The Effect of Art Therapy on Pain, Emesis, Anxiety and Quality of Life in Operated Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Actual)
Study Completion Date
October 7, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cumhuriyet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The research sample consisted of 60 individuals, including the intervention group (n=30) and the control group (n=30), who received treatment at the Oncology Center of Sivas Cumhuriyet University Practice and Research Hospital. Personal Information Form, Pain Intensity Measurement-Visual Analog Scale, Rhodes nausea, vomiting and retching index, Beck Anxiety Inventory, FACT-G Quality of Life Scale were applied to the research data. Toxicity Rating Scale total score was recorded from the patient file. Within the scope of the research, a chemotherapy session for 10 weeks (5 sessions) with an interval of two weeks was made by the art expert of the art of marbling, accompanied by a ney concert. No intervention was made in the control group. Within the scope of the research, scale forms will be applied to both groups in the first interview, in the 3rd and 5th chemotherapy sessions of the patients. The data obtained from the study were uploaded to the SPSS (22.0) program and statistical evaluation was made.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer,, art therapy, marbling art, music therapy, pain,, emesis,, anxiety, quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Within the scope of the research, the art of marbling was made by the art expert, accompanied by a total of 5 sessions ney concerts for 10 weeks, with two-week intervals. The art application was made to last 20-30 minutes before the patients received chemotherapy. The scales were administered to the individuals in the intervention groups three times in total.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
No treatment was applied to the control group. The scales were administered to the individuals in the control groups three times in total.
Intervention Type
Other
Intervention Name(s)
Art therapy
Intervention Description
The intervention group is the group in which art therapy is applied. They receive chemotherapy.
Primary Outcome Measure Information:
Title
Visual Analog Scale:
Description
It is a scale used to evaluate the pain experienced by patients. Scale; It contains the numbers "start 0 (no pain)" and "10 (severe pain)" at the other end. The patient marks the level of pain he experiences based on these two values.
Time Frame
It will take 10 weeks to collect data three times after randomization is done. The first measurement of pain will be done in the first week, the second measurement in the fifth week and the third measurement in the tenth week.
Title
The Rhodes index of nausea, vomiting and retching (RINVR)
Description
They found that the alpha internal consistency coefficient of the Nausea, Vomiting and Regurgitation Index, developed by Rhodes and McDaniel and validity and reliability by Rhodes and McDaniel, ranged from 0.98, and the alpha internal consistency coefficients of the subgroups ranged between 0.83 and 0.99. Each response is scored as 0 = least distress, 4 = most distress. The patient's experience of nausea and vomiting in each of the 8 items is summed up. The highest possible value is 32 and represents the most severe symptom occurrence score.It was adapted to Turkish society by Tan and Genç (2010).
Time Frame
It will take 10 weeks to collect data three times after randomization is done. The first measurement of nausea, vomiting will be done in the first week, the second measurement in the fifth week and the third measurement in the tenth week.
Title
Beck Anxiety Scale (BAI)
Description
Beck et al. (1988) in order to determine the frequency of anxiety symptoms experienced by the individual. The scale is a Likert-type self-assessment scale consisting of 21 items and scored between 0-3. The high total score indicates the high level of anxiety experienced by the person. The score range ranges from 0 to 63. Evaluation of the scale is 0-7 points for no anxiety symptoms, 8-15 for mild anxiety, 16-25 for moderate anxiety, and 26-63 for severe anxiety symptoms.
Time Frame
It will take 10 weeks to collect data three times after randomization is done. The first measurement of anxiety will be done in the first week, the second measurement in the fifth week and the third measurement in the tenth week.
Title
FACT-G Quality of Life Scale
Description
FACT-G is a quality of life scale. In the Turkish naming of this scale, the abbreviation of the original scale [Functional Assessment of Cancer Therapy- General] (FACT-G) is used. It was developed by Cella et al. in 1993. The Turkish validity and reliability of the scale were performed by Çetiner et al. in 2004. This scale has 4 subgroups consisting of 28 items: physical condition, social life and family status, activity status and emotional state. Total scale score is obtained by summing the scores of all items and subgroup scores are obtained by summing the scores of the items in the subgroup. High scores on the total scale and subgroups suggest that patients' quality of life is also high.
Time Frame
It will take 10 weeks to collect data three times after randomization is done. The first measurement of quality of life will be done in the first week, the second measurement in the fifth week and the third measurement in the tenth week.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who have received at least one course of chemotherapy, who have undergone breast surgery, who have not been given art therapy, who have no communication difficulties and no mental problems, who are 18 years of age or older, and who agreed to participate in the study. Exclusion Criteria: Those with cancer stage IV, visual, hearing and communication difficulties, those under the age of 18 and those who wanted to leave the study were not included in the study.
Facility Information:
Facility Name
Esra BAŞER AKIN
City
Sivas
ZIP/Postal Code
58000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effect of Art Therapy on Pain, Emesis, Anxiety and Quality of Life, Breast Cancer

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