The Effect of Using a Stress Ball on Pain, Anxiety, and Vital Signs During Breast Biopsy
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Evrim Bayraktar, Assoc. Prof. Dr.
- Telefoonnummer: +905332156825
- E-mail: ealbayrak@erciyes.edu.tr
Studie Contact Back-up
- Naam: Meryem Tuğba Ton, RN, BSN
- Telefoonnummer: +905078781249
- E-mail: meryemtubaton@gmail.com
Studie Locaties
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-
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Kayseri, Turkije (Türkiye)
- Werving
- Erciyes University Faculty of Medicine Hospitals
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Contact:
- Evrim Bayraktar, Assoc. Prof. Dr.
- Telefoonnummer: +90 352 437 9281
- E-mail: ealbayrak@erciyes.edu.tr
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Scheduled for Tru-Cut breast biopsy
- Aged 18 years and older
- Undergoing breast biopsy for the first time
- Able to speak Turkish
- Female sex
- Not pregnant
- Not breastfeeding
- No cognitive, verbal, or hearing impairments that could impede communication
- Voluntarily agreeing to participate in the study with written and verbal informed consent
Exclusion Criteria:
- 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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Stress Ball
Participants in this group will squeeze a stress ball during the breast biopsy procedure. |
Participants will squeeze a stress ball during the biopsy procedure |
|
Geen tussenkomst: Routine Care
Participants will receive standard care without any stress ball application. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Pain Score Assessed by Visual Analog Scale (VAS)
Tijdsspanne: Immediately after the biopsy procedure
|
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. |
Immediately after the biopsy procedure
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Anxiety Score Assessed by State-Trait Anxiety Inventory (STAI-S)
Tijdsspanne: Baseline (before the procedure) and immediately after the biopsy procedure
|
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. |
Baseline (before the procedure) and immediately after the biopsy procedure
|
|
Trait Anxiety Score Assessed by State-Trait Anxiety Inventory (STAI-T)
Tijdsspanne: Immediately after the biopsy procedure
|
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. |
Immediately after the biopsy procedure
|
|
Changes in Vital Signs (Body Temperature)
Tijdsspanne: Baseline (before the procedure) and immediately after the biopsy procedure
|
Body temperature (°C) will be recorded. |
Baseline (before the procedure) and immediately after the biopsy procedure
|
|
Changes in Vital Signs (Heart Rate)
Tijdsspanne: Baseline (before the procedure) and immediately after the biopsy procedure
|
Heart rate will be recorded in beats per minute (bpm). |
Baseline (before the procedure) and immediately after the biopsy procedure
|
|
Changes in Vital Signs (Respiratory Rate)
Tijdsspanne: Baseline (before the procedure) and immediately after the biopsy procedure
|
Respiratory rate will be recorded in breaths per minute. |
Baseline (before the procedure) and immediately after the biopsy procedure
|
|
Changes in Vital Signs (Systolic Blood Pressure)
Tijdsspanne: Baseline (before the procedure) and immediately after the biopsy procedure
|
Systolic blood pressure (mmHg) will be recorded. |
Baseline (before the procedure) and immediately after the biopsy procedure
|
|
Changes in Vital Signs (Diastolic Blood Pressure)
Tijdsspanne: Baseline (before the procedure) and immediately after the biopsy procedure
|
Diastolic blood pressure (mmHg) will be recorded. |
Baseline (before the procedure) and immediately after the biopsy procedure
|
|
Changes in Vital Signs (Peripheral Oxygen Saturation)
Tijdsspanne: Baseline (before the procedure) and immediately after the biopsy procedure
|
Peripheral oxygen saturation (SpO2, %) will be recorded. |
Baseline (before the procedure) and immediately after the biopsy procedure
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Evrim Bayraktar, Assoc. Prof. Dr., TC Erciyes University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- TYL-2026-15599
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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