Stress Ball Use During Chemotherapy in Gastrointestinal Cancer Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorArtvin Coruh University

About this trial

This study will investigate whether using a stress ball during chemotherapy can reduce anxiety, fear, and changes in vital signs in patients with gastrointestinal system cancers.

Patients receiving chemotherapy for gastrointestinal cancers often experience anxiety and fear, which may affect their heart rate, blood pressure, and breathing. A stress ball is a simple, low-cost, and safe method that may help patients relax during treatment.

In this randomized controlled study, 60 patients receiving chemotherapy will be assigned to either a stress ball group or a routine care group. Patients in the stress ball group will squeeze a stress ball for 15 minutes during their chemotherapy session. Anxiety, fear levels, and vital signs will be measured before and after chemotherapy in both groups.

The results of this study may help determine whether stress ball use is an effective non-drug method to improve emotional well-being and physiological stability in patients undergoing chemotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Being aged 18 years or older

Having a diagnosis of gastrointestinal system cancer and receiving chemotherapy

Having no communication problems

Having no physical disability that would prevent squeezing a stress ball

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stress Ball

    Behavioral

    The intervention consists of guided stress ball squeezing during chemotherapy. A round, medium-firm, compressible stress ball approximately 5-6 cm in diameter will be provided to participants. Starting at the beginning of the chemotherapy session, participants will squeeze the stress ball continuously for 15 minutes. They will be instructed to inhale while squeezing the ball, exhale while releasing their grip, and focus their attention on the squeezing activity. Disposable gloves will be used to maintain hygiene during the intervention. No additional behavioral or pharmacological interventions will be applied.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Stress Ball InterventionExperimental treatment 1 intervention
Group B: Routine Care ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

State Anxiety (STAI-State) score

Time frame
Baseline (before chemotherapy session) and immediately after chemotherapy session

Secondary outcomes

1

Fear Severity (VAS-Fear)

Fear severity will be measured using a Visual Analog Scale (VAS-Fear). The change in scores before and after chemotherapy will be evaluated to assess the effect of the intervention on fear.

Time frame
Baseline (before chemotherapy session) and immediately after chemotherapy session
2

Systolic Blood Pressure

Systolic blood pressure measured using an automatic sphygmomanometer.

Time frame
Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.
3

Diastolic Blood Pressure

Diastolic blood pressure measured using an automatic sphygmomanometer.

Time frame
Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.
4

Heart Rate (Pulse)

Heart rate measured in beats per minute using an pulse oximeter

Time frame
Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.

Other outcomes

Sponsors and contacts

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