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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Evrim Bayraktar, Assoc. Prof. Dr.
- Telefonnummer: +905332156825
- E-Mail: ealbayrak@erciyes.edu.tr
Studieren Sie die Kontaktsicherung
- Name: Meryem Tuğba Ton, RN, BSN
- Telefonnummer: +905078781249
- E-Mail: meryemtubaton@gmail.com
Studienorte
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Kayseri, Türkei (türkiye)
- Rekrutierung
- Erciyes University Faculty of Medicine Hospitals
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Kontakt:
- Evrim Bayraktar, Assoc. Prof. Dr.
- Telefonnummer: +90 352 437 9281
- E-Mail: ealbayrak@erciyes.edu.tr
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: 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 |
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Kein Eingriff: Routine Care
Participants will receive standard care without any stress ball application. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Pain Score Assessed by Visual Analog Scale (VAS)
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Anxiety Score Assessed by State-Trait Anxiety Inventory (STAI-S)
Zeitfenster: 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)
Zeitfenster: 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
|
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Changes in Vital Signs (Body Temperature)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
|
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Changes in Vital Signs (Diastolic Blood Pressure)
Zeitfenster: 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
|
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Changes in Vital Signs (Peripheral Oxygen Saturation)
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Studienleiter: Evrim Bayraktar, Assoc. Prof. Dr., TC Erciyes University
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- TYL-2026-15599
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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