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OpenTrials
Completed

NCT Number: NCT06956066

The Effect of SHOTBLOCKER

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul

Istanbul, Kartal, 34862, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

shotblocker

Biological

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.

Primary outcomes

  1. Beck Anxiety Inventory

    Time frame: Time Frame: up to 1 day

    • 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

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study title

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

Acronym: SHOTBLOCKER

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 2, 2025
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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