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Completed

NCT Number: NCT05666583

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

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.

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Key information

Conditions

Breast Cancer Anxiety Disorders Breast Diseases Breast Neoplasms Mental Disorders Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Skin Diseases Skin and Connective Tissue Diseases Vomiting

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Esra BAŞER AKIN

Sivas, 58000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Art therapy

Other

The intervention group is the group in which art therapy is applied. They receive chemotherapy.

Primary outcomes

  1. Visual Analog Scale:

    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.

    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.

  2. The Rhodes index of nausea, vomiting and retching (RINVR)

    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.

    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).

  3. Beck Anxiety Scale (BAI)

    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.

    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.

  4. FACT-G Quality of Life Scale

    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.

    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.

Sponsors and collaborators

Lead sponsor

Cumhuriyet University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 28, 2022
Registry last updated
Dec 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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