NCT07383935

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress26%
Feb 2026Feb 2027

First Submitted

Initial submission to the registry

January 19, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

February 3, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 3, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 3, 2027

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

January 19, 2026

Last Update Submit

February 8, 2026

Conditions

Gastrointestinal System Cancer

Outcome Measures

Primary Outcomes (1)

  • State Anxiety (STAI-State) score

    Baseline (before chemotherapy session) and immediately after chemotherapy session

Secondary Outcomes (7)

  • Fear Severity (VAS-Fear)

    Baseline (before chemotherapy session) and immediately after chemotherapy session

  • Systolic Blood Pressure

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

  • Diastolic Blood Pressure

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

  • Heart Rate (Pulse)

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

  • Respiratory Rate

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

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

Stress BallBEHAVIORAL

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.

Stress Ball Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Artvin State Hospital

Artvin, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal Diseases

Central Study Contacts

Efe Hasdemir Efe Hasdemir, MD

CONTACT

+90 5433750709hasdemir52@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The Effect of Stress Ball on Anxiety, Fear, and Vital Signs in Patients With Gastrointestinal System Cancer

Study Record Dates

First Submitted

January 19, 2026

First Posted

February 3, 2026

Study Start

February 3, 2026

Primary Completion (Estimated)

February 3, 2027

Study Completion (Estimated)

February 3, 2027

Last Updated

February 11, 2026

Record last verified: 2026-02

Locations

TU(1)