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NCT Number: NCT07383935

Stress Ball Use During Chemotherapy in Gastrointestinal Cancer Patients

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.

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Key information

Conditions

Gastrointestinal System Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Artvin State Hospital

Artvin, Turkey (Türkiye)

Location status: Recruiting

Location contact

Efe Hasdemir, MD

CONTACT

[email protected]

About this study

This study is a randomized controlled experimental trial designed to evaluate the effects of stress ball use during chemotherapy on anxiety, fear, and vital signs in patients with gastrointestinal system cancers.

Participants will be adult patients diagnosed with gastrointestinal system cancers who are receiving chemotherapy at the Artvin State Hospital Chemotherapy Unit. Eligible patients who provide informed consent will be randomly assigned in a 1:1 ratio to either an experimental group (stress ball intervention) or a control group (routine care).

Patients in the experimental group will be instructed to squeeze a medium-firm stress ball for 15 minutes starting at the beginning of their chemotherapy session. They will be guided to inhale while squeezing the ball and exhale while releasing it, focusing their attention on the activity. Patients in the control group will receive routine chemotherapy care without any additional intervention.

Anxiety and fear levels will be assessed before and after chemotherapy using validated measurement tools. Vital signs including blood pressure, heart rate, respiratory rate, body temperature, and oxygen saturation will also be recorded before and after the chemotherapy session. Outcomes will be compared between and within groups to determine the effectiveness of the stress ball intervention.

This study aims to provide evidence on whether a simple non-pharmacological method can improve psychological well-being and physiological stability during chemotherapy in patients with gastrointestinal system cancers.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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
  • Willingness to participate in the study

Exclusion criteria

-

Treatment and study plan

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.

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)

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

    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.

  2. Systolic Blood Pressure

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

    Systolic blood pressure measured using an automatic sphygmomanometer.

  3. Diastolic Blood Pressure

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

    Diastolic blood pressure measured using an automatic sphygmomanometer.

  4. Heart Rate (Pulse)

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

    Heart rate measured in beats per minute using an pulse oximeter

  5. Respiratory Rate

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

    Respiratory rate measured by counting chest movements for one minute.

  6. Body Temperature

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

    Body temperature measured using a tympanic thermometer.

  7. Oxygen Saturation (SpO₂)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Efe Hasdemir Efe Hasdemir, MD

CONTACT

[email protected]

+90 5433750709

Sponsors and collaborators

Lead sponsor

Artvin Coruh University

Other

Registry information

Official study title

The Effect of Stress Ball on Anxiety, Fear and Vital Signs in Patients With Gastrointestinal System Cancer

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 3, 2026
Registry last updated
Feb 11, 2026

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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