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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Evrim Bayraktar, Assoc. Prof. Dr.
- Numéro de téléphone: +905332156825
- E-mail: ealbayrak@erciyes.edu.tr
Sauvegarde des contacts de l'étude
- Nom: Meryem Tuğba Ton, RN, BSN
- Numéro de téléphone: +905078781249
- E-mail: meryemtubaton@gmail.com
Lieux d'étude
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Kayseri, Turquie (Türkiye)
- Recrutement
- Erciyes University Faculty of Medicine Hospitals
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Contact:
- Evrim Bayraktar, Assoc. Prof. Dr.
- Numéro de téléphone: +90 352 437 9281
- E-mail: ealbayrak@erciyes.edu.tr
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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 |
|
Aucune intervention: Routine Care
Participants will receive standard care without any stress ball application. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pain Score Assessed by Visual Analog Scale (VAS)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Anxiety Score Assessed by State-Trait Anxiety Inventory (STAI-S)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Evrim Bayraktar, Assoc. Prof. Dr., TC Erciyes University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TYL-2026-15599
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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