Back to resultsAnxiety on the First Day of Chemotherapy
Primary Purpose
Breast Cancer, Anxiety
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
waiting room enriched with music, paintings and artificial plants
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- to receive chemotherapy for breast cancer for the first time
- give consent for the study
Exclusion Criteria:
- not approving to participate in the study
Sites / Locations
- Tekirdağ Namık Kemal ÜNiversitesi
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
standard waiting room
waiting room enriched with art objects
Arm Description
standard chemoterapy waiting room
waiting room enriched with music, paintings and artificial plants
Outcomes
Primary Outcome Measures
anxiety and stress measurements
The State-Trait Anxiety Inventory (STAI) - Measuring anxiety with the Hospital Anxiety and Depression Scale (HADS)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04839835
Brief Title
Anxiety on the First Day of Chemotherapy
Official Title
The Effect of Art Design in the Chemotherapy Waiting Room on the Anxiety of Patients Who Will Receive Chemotherapy for the First Time
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
August 31, 2021 (Anticipated)
Study Completion Date
March 3, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Namik Kemal 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
investigating chemotherapy anxieties
Detailed Description
Breast cancer is the most common type of cancer in women in the world, and it is the first in cancer-related deaths in women all over the world. In the treatment of breast cancer, in addition to surgery, patients with advanced stage or high risk of recurrence receive neoadjuvant and adjuvant chemotherapy treatments. This period starts with 3 months and extends according to the treatment protocols it will receive.
Since the first diagnosis of breast cancer, it has psychological effects such as intense stress, decrease in quality of life and anxiety as well as physical effects on patients. The time spent in the "waiting room" while patients are examined and receiving treatment before chemotherapy inevitably has an effect on their anxiety.
In this study; It was aimed to investigate the effects of environmental factors in waiting rooms on patients' anxiety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Anxiety
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
standard waiting room
Arm Type
No Intervention
Arm Description
standard chemoterapy waiting room
Arm Title
waiting room enriched with art objects
Arm Type
Experimental
Arm Description
waiting room enriched with music, paintings and artificial plants
Intervention Type
Other
Intervention Name(s)
waiting room enriched with music, paintings and artificial plants
Intervention Description
waiting room enriched with music, paintings and artificial plants
Primary Outcome Measure Information:
Title
anxiety and stress measurements
Description
The State-Trait Anxiety Inventory (STAI) - Measuring anxiety with the Hospital Anxiety and Depression Scale (HADS)
Time Frame
60-120 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
to receive chemotherapy for breast cancer for the first time
give consent for the study
Exclusion Criteria:
not approving to participate in the study
Facility Information:
Facility Name
Tekirdağ Namık Kemal ÜNiversitesi
City
Tekirdağ
ZIP/Postal Code
59100
Country
Turkey
12. IPD Sharing Statement
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Anxiety on the First Day of Chemotherapy
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