Anxiety on the First Day of Chemotherapy

Sponsor

Namik Kemal University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04839835

Collaborator

(none)

106

Enrollment

Location

Arms

Anticipated Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

investigating chemotherapy anxieties

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Anxiety	Other: waiting room enriched with music, paintings and artificial plants	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

106 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Actual Study Start Date :

Nov 1, 2020

Anticipated Primary Completion Date :

Aug 31, 2021

Anticipated Study Completion Date :

Mar 3, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: standard waiting room standard chemoterapy waiting room
Experimental: waiting room enriched with art objects waiting room enriched with music, paintings and artificial plants	Other: waiting room enriched with music, paintings and artificial plants waiting room enriched with music, paintings and artificial plants

Arm

Intervention/Treatment

No Intervention: standard waiting room

standard chemoterapy waiting room

Experimental: waiting room enriched with art objects

waiting room enriched with music, paintings and artificial plants

Other: waiting room enriched with music, paintings and artificial plants

waiting room enriched with music, paintings and artificial plants

Outcome Measures

Primary Outcome Measures

anxiety and stress measurements [60-120 minutes]
The State-Trait Anxiety Inventory (STAI) - Measuring anxiety with the Hospital Anxiety and Depression Scale (HADS)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tekirdağ Namık Kemal ÜNiversitesi	Tekirdağ		Turkey	59100

Sponsors and Collaborators

Namik Kemal University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Asoc. Prof. Erdoğan Selçuk Şeber, Asoc. Prof., Namik Kemal University

ClinicalTrials.gov Identifier:

NCT04839835

Other Study ID Numbers:

waitingroom

First Posted:

Apr 9, 2021

Last Update Posted:

Apr 9, 2021

Last Verified:

Apr 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Apr 9, 2021