The Effect of SHOTBLOCKER (SHOTBLOCKER)

THE EFFECT OF SUBCUTANEOUS "SHOTBLOCKER" ON INJECTION PAIN, ANXIETY AND COMFORT LEVEL IN GERIATRIC PATIENTS

This study was conducted as a randomized controlled experimental cross over study to examine the effect of injection pain, anxiety and comfort level with the use of Shotblocker in geriatric patients undergoing subcutaneous injection. The study was defined on 80 patients who were inpatients in the internal wards of a hospital, and the experimental and control groups, which provided the appropriate conditions for the study, included the same people. Ethics committee approval, institutional permission and written informed consent forms were obtained from the individuals. Data were obtained by the researcher using Personal Information Form, Visual Analog Scale (VAS), State and Trait Anxiety Scale, Comfort Scale, Visual Patient Satisfaction Scale and Shotblocker.

Study Overview

• Status: Completed
• Conditions: Pain; Anxiety; Injection Pain Prevention; Shotblocker
• Intervention / Treatment: Biological: shotblocker

Detailed Description

This study was conducted as a randomized controlled experimental cross over study to examine the effect of injection pain, anxiety and comfort level with the use of Shotblocker in geriatric patients undergoing subcutaneous injection. The study was defined on 80 patients who were inpatients in the internal wards of a hospital, and the experimental and control groups, which provided the appropriate conditions for the study, included the same people. Ethics committee approval, institutional permission and written informed consent forms were obtained from the individuals. Data were obtained by the researcher using Personal Information Form, Visual Analog Scale (VAS), State and Trait Anxiety Scale, Comfort Scale, Visual Patient Satisfaction Scale and Shotblocker.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kartal
    • İstanbul, Kartal, Turkey, 34862
      • İstanbul

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Voluntary participants in the study, Over 65 years of age, Cognitive ability to answer the questions, Body Mass Index (BMI) 18.5- 29.9 kg / m2, No communication problems, Subcutaneous injection in the treatment, No bleeding coagulation disorder, Platelet, INR and APTT values within normal limits, No scar tissue, incision or infection findings in the injection area, No history of allergy

Exclusion Criteria:

Patients with amputation in the right/left arm area to be studied, Patients with any scar tissue, incision, lipodystrophy or signs of infection in the injection area in the arm area, Patients receiving hemodialysis treatment and having a dialysis catheter, Patients who underwent mastectomy surgery and should not undergo any application/treatment on the arm on the operated side were excluded from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: shotblocker; injection with shotblocker	Biological: shotblocker; SHOTBLOCKER Shotblocker is a drug-free and non-invasive plastic device for all age groups that is placed during injection to press against the site of administration. It has standardized dimensions and is designed in a small, flat, horseshoe (U) shape with several blunt points on one surface in direct contact with the skin.
No Intervention: Control; Normal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Anxiety Inventory	1. Beck Anxiety Inventory Description: It is a Likert-type scale consisting of 21 items and scored between 0-3. According to scale scoring; 8 points: No anxiety, 8-15 points: Mild anxiety, 16-25 points: Moderate anxiety, 26-63 points: Determined as severe anxiety decrease the15 points	Time Frame: up to 1 day

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2023
• Primary Completion (Actual): November 23, 2024
• Study Completion (Actual): December 21, 2024

Study Registration Dates

• First Submitted: April 25, 2025
• First Submitted That Met QC Criteria: April 25, 2025
• First Posted (Actual): May 2, 2025

Study Record Updates

• Last Update Posted (Actual): May 2, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: pain; anxiety; injection; Shotblocker
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: IstanbulMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No