The Effect of Stress Ball Use on Stress, Anxiety, and Vital Signs in Patients Undergoing Chemotherapy for Breast Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorAtaturk University

About this trial

AIM This study aims to investigate the effects of stress ball use on stress, anxiety, and vital signs in patients receiving chemotherapy for breast cancer.

METHOD This study will be conducted with 50 breast cancer patients receiving chemotherapy at the Outpatient Chemotherapy Unit of Rize Training and Research Hospital, using a randomized controlled experimental design. Simple randomization will be used for group assignment. Data will be collected using a Breast Cancer Patient Information Form, Distress Thermometer, and State Anxiety Inventory. It is planned that data will be collected both before and after the chemotherapy session.

ORIGINALITY / SCIENTIFIC CONTRIBUTION To date, no study has been found in the literature evaluating the effects of stress balls on stress, anxiety, and vital signs in breast cancer patients undergoing chemotherapy. Therefore, this project is considered original and is expected to contribute to both national and international scientific literature. If successful, the project will provide evidence for a new non-pharmacological intervention that is easy to use during chemotherapy sessions and can help improve patients' stress, anxiety, and vital signs. Patients may experience more comfort and better treatment compliance during chemotherapy.

EXPECTED OUTCOMES It is expected that the use of a stress ball will have a positive effect on reducing stress and anxiety levels and improving vital signs in breast cancer patients receiving chemotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Stage 2A-2B breast cancer

Receiving neoadjuvant chemotherapy

On a chemotherapy protocol administered every 21 days

Receiving second or subsequent chemotherapy cycle

Disqualifiers

Cancer types other than breast cancer

Unilateral or bilateral mastectomy

Any condition preventing hand use (e.g., pain, fracture, open wound)

IV access in both arms

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stress ball

    Other intervention

    First Interview: Consent is obtained; group allocation is done. Pre-test: Patient information form, DT, STAI, and vital signs are assessed. Intervention: Stress ball use for 15-20 minutes during chemotherapy. Post-test: Same measurements are repeated.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Stress ball groupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Distress Thermometer (DT):

It assesses the state anxiety an individual feels due to the stressful situation they are in, their predisposition to this anxiety, and the trait anxiety that generally characterizes the situations they find themselves in as stressful. The total score on the scale ranges from 20 to 80, with higher scores indicating higher anxiety levels and lower scores indicating lower anxiety levels.

Time frame
1 per month for 3 months

Secondary outcomes

1

State Anxiety Inventory (STAI):

It assesses the state anxiety an individual feels due to the stressful situation they are in, their predisposition to this anxiety, and the trait anxiety that generally characterizes the situations they find themselves in as stressful. The total score on the scale ranges from 20 to 80, with higher scores indicating higher anxiety levels and lower scores indicating lower anxiety levels.

Time frame
1 per month for 3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Ataturk University

Lead sponsor

Ataturk Training and Research Hospital

Sponsor institution

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