Gastrointestinal System CancerNCT07383935
Stress Ball Use During Chemotherapy in Gastrointestinal Cancer Patients
A study testing Stress Ball in people with Gastrointestinal System Cancer, run by Artvin Coruh University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal System Cancer
- What is being tested?
- Stress Ball
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Feb 2026to 3 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Artvin State Hospital
Artvin
Efe Hasdemir, MD, emre.erkal@artvin.edu.tr
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Gastrointestinal System Cancer
- Being tested
- Stress Ball
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress BallBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Stress Ball Intervention | Experimental | 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. Receives: Behavioral: Stress Ball |
| Routine Care Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety (STAI-State) score
Measured: Baseline (before chemotherapy session) and immediately after chemotherapy session
Secondary outcomes (7)
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.
Measured: Baseline (before chemotherapy session) and immediately after chemotherapy session
Systolic Blood Pressure
Systolic blood pressure measured using an automatic sphygmomanometer.
Measured: Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.
Diastolic Blood Pressure
Diastolic blood pressure measured using an automatic sphygmomanometer.
Measured: Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.
Heart Rate (Pulse)
Heart rate measured in beats per minute using an pulse oximeter
Measured: Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.
Respiratory Rate
Respiratory rate measured by counting chest movements for one minute.
Measured: Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session
Body Temperature
Body temperature measured using a tympanic thermometer.
Measured: Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.
Oxygen Saturation (SpO₂)
Measured: Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start3 Feb 2026
- Primary completion3 Feb 2027 (estimated)
- Study completion3 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal System CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Artvin Coruh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EMRE ERKAL, Artvin Coruh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07383935
- Sponsor's protocol ID
- GIS-STRESSBALL-2026
- Status last verified
- Feb 2026
- First submitted
- 19 Jan 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Stress Ball on Anxiety, Fear and Vital Signs in Patients With Gastrointestinal System Cancer
- ClinicalTrials.gov ID
- NCT07383935
- Acronym / sponsor ID
- GIS-STRESSBALL-2026
- Conditions
- Gastrointestinal System Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Artvin Coruh UniversityUniversity, hospital or other
- Study start
- 3 Feb 2026 (actual)
- Primary completion
- 3 Feb 2027 (estimated)
- Study completion
- 3 Feb 2027 (estimated)
- First posted
- 3 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress Ball Intervention | Experimental | Behavioral: Stress BallParticipants 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. |
| Routine Care Control | No intervention | –Participants in this arm will receive routine chemotherapy care during their chemotherapy session and will not perform any stress ball or additional relaxation intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress BallThe 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. | Behavioural | Stress Ball Intervention |
Primary outcome
State Anxiety (STAI-State) score
Time frame: Baseline (before chemotherapy session) and immediately after chemotherapy session
7 secondary outcomes
Fear Severity (VAS-Fear)
Time frame: Baseline (before chemotherapy session) and immediately after chemotherapy session
Systolic Blood Pressure
Time frame: 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.
Heart Rate (Pulse)
Time frame: Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.
Respiratory Rate
Time frame: Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session
Body Temperature
Time frame: Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.
Oxygen Saturation (SpO₂)
Time frame: Baseline (immediately before chemotherapy session) and immediately after completion of the chemotherapy session.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stress Ball in people with Gastrointestinal System Cancer, run by Artvin Coruh University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Efe Hasdemir Efe Hasdemir, MD (+90 5433750709, hasdemir52@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Anxiety (STAI-State) score (time frame: Baseline (before chemotherapy session) and immediately after chemotherapy session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.