Clinical trial NCT06956066: The Effect of SHOTBLOCKER
Official title: THE EFFECT OF SUBCUTANEOUS "SHOTBLOCKER" ON INJECTION PAIN, ANXIETY AND COMFORT LEVEL IN GERIATRIC PATIENTS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shotblocker
Injection Pain Prevention
Pain
Anxiety
Keywords: Shotblocker
injection
pain
anxiety
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Assuming a power of 80% and an α risk of. 05, a sample size of 75 was determined to be appropriate. Considering the possibility of missing data, the study initially included 80 participants in both the experimental and control groups. A computer-based random number generator was used for group assignment, and allocation concealment was ensured by using sealed envelopes containing random numbers opened by a separate researcher. The study was completed with 40 participants in the experimental group and 40 in the control group, due to some participants withdrawing.
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Beck Anxiety Inventory
timeFrame: Time Frame: up to 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul
state: Kartal
Study officials:
References: