- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07383935
Stress Ball Use During Chemotherapy in Gastrointestinal Cancer Patients
The Effect of Stress Ball on Anxiety, Fear and Vital Signs in Patients With Gastrointestinal System Cancer
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Efe Hasdemir Efe Hasdemir, MD
- Phone Number: +90 5433750709
- Email: hasdemir52@gmail.com
Study Locations
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-
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Artvin, Turkey (Türkiye)
- Recruiting
- Artvin State Hospital
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Contact:
- Efe Hasdemir, MD
- Email: emre.erkal@artvin.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Stress Ball Intervention
Participants in this arm will receive routine chemotherapy care and will additionally perform stress ball squeezing for 15 minutes starting at the beginning of the chemotherapy session.
Patients will be instructed to inhale while squeezing the ball and exhale while releasing it, focusing attention on the activity.
|
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.
|
|
No Intervention: Routine Care Control
Participants in this arm will receive routine chemotherapy care during their chemotherapy session and will not perform any stress ball or additional relaxation intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
State Anxiety (STAI-State) score
Time Frame: Baseline (before chemotherapy session) and immediately after chemotherapy session
|
Baseline (before chemotherapy session) and immediately after chemotherapy session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (before chemotherapy session) and immediately after chemotherapy session
|
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Systolic Blood Pressure
Time Frame: Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.
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Systolic blood pressure measured using an automatic sphygmomanometer.
|
Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.
|
|
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.
|
Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.
|
|
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
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Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.
|
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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.
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Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session
|
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Body Temperature
Time Frame: Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.
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Body temperature measured using a tympanic thermometer.
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Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.
|
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Oxygen Saturation (SpO₂)
Time Frame: Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.
|
Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GIS-STRESSBALL-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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