The Effect of Using a Stress Ball on Pain, Anxiety, and Vital Signs During Breast Biopsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorTC Erciyes University
About this trial
Breast biopsy is an invasive diagnostic procedure commonly performed for the histopathological diagnosis of breast lesions and can be associated with anxiety and pain. Procedural anxiety and pain may also influence physiological responses, including changes in blood pressure and heart rate. Therefore, non-pharmacological nursing interventions that are simple, low-cost, and easy to implement may be useful in managing procedural distress.
This study aims to investigate the effect of stress ball use during breast biopsy on patients' pain, anxiety, and vital signs. Participants will be assigned to an intervention group using a stress ball during the biopsy procedure or a control group receiving standard care. Pain and anxiety levels, as well as vital signs, will be assessed and compared between the two groups.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Scheduled for Tru-Cut breast biopsy
Aged 18 years and older
Undergoing breast biopsy for the first time
Able to speak Turkish
Disqualifiers
Chronic pain disorders or regular use of analgesics
Having taken analgesic medication on the day of the procedure
Inability to use the hands or impaired grip/grasp function
Trial design
Design model
Parallel
Treatments tested in this trial
Using a Stress Ball
BehavioralParticipants will squeeze a stress ball during the biopsy procedure
Treatment groups
53 Participants
are divided into 2 treatment groupsGroup A: Stress BallExperimental treatment 1 intervention
Group B: Routine CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Pain Score Assessed by Visual Analog Scale (VAS)
Pain intensity will be evaluated using a 10-cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater pain intensity.
Time frame
Immediately after the biopsy procedureSecondary outcomes
1
Anxiety Score Assessed by State-Trait Anxiety Inventory (STAI-S)
Situational anxiety will be assessed using the State Anxiety Scale (STAI-S). Scores range from 20 to 80, with higher scores reflecting higher anxiety levels.
Time frame
Baseline (before the procedure) and immediately after the biopsy procedure2
Trait Anxiety Score Assessed by State-Trait Anxiety Inventory (STAI-T)
General anxiety disposition will be assessed using the Trait Anxiety Scale (STAI Form TX-2 / STAI-T). The total score ranges from 20 to 80, with higher scores reflecting higher levels of trait anxiety.
Time frame
Immediately after the biopsy procedure3
Changes in Vital Signs (Body Temperature)
Body temperature (°C) will be recorded.
Time frame
Baseline (before the procedure) and immediately after the biopsy procedure4
Changes in Vital Signs (Heart Rate)
Heart rate will be recorded in beats per minute (bpm).
Time frame
Baseline (before the procedure) and immediately after the biopsy procedureSponsors and contacts
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Source ClinicalTrials.gov