Effect of Different Subcutaneous Injection Methods on Pain and Satisfaction

Evaluation of the Effects of Different Methods Used in Subcutaneous Heparin Injections on Pain and Satisfaction

This study; In patients treated with subcutaneous heparin A randomized controlled trial was planned to determine the effect of the injection time and the device called "Palm Stimulator" to reduce the pain felt during injection.

Study Overview

• Status: Completed
• Conditions: Pain, Acute; Injection Site
• Intervention / Treatment: Other: injection time; Other: palm stimulator; Other: injection time and palm stimulator

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Edirne, Turkey
    • Trakya Üniversitesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Above 18 years old
• The one who is literate,
• No physical, mental disabilities or communication difficulties,
• Low Molecular Weight Heparin in the treatment plan,
• No history of allergy,
• Agreeing to participate in the research,
• There is no scar tissue, incision or infection in the area to be injected,
• Patients who will receive a 1-day injection and whose pain score is between 1-10 according to VAS will be admitted.

Exclusion Criteria:

• Who gave up participating in the research while continuing the research,
• Using subcutaneous insulin therapy,
• There is an amputation in the right/left arm area where the study will be performed,
• There is scar tissue, incision or signs of infection in the area to be injected,
• Patients who received injections for 1 day and whose pain score is 0 (zero) according to VAS will not be admitted.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: injection time; The application will be done by injecting for 30 seconds and then waiting for 10 seconds and ending the process.	Other: injection time; give an injection
Experimental: palm stimulator; By ensuring that the patient grasps the "palm stimulator" equipment in the palm during the injection and squeezes it in the palm throughout the injection. Tactile warning will be given. However, the injection process will last 10 seconds and the process will be terminated after waiting 10 seconds.	Other: palm stimulator; give an injection
Experimental: injection time and palm stimulator; Injection will be done for 30 seconds and then waited for 10 seconds and the process will be terminated, and the application will be done using equipment.	Other: injection time and palm stimulator; give an injection
No Intervention: control group; The injection process will last 10 seconds and the process will be terminated after waiting 10 seconds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scale Patient Identification Form	Patient Identification Form It was prepared by researchers by examining the literature on the subject. This form includes 5 questions that include some sociodemographic characteristics of the individual (age, gender, marital status, education status, employment status, etc.) and 8 questions that include characteristics related to health, illness and treatment (presence of chronic disease, body mass index, etc.).	during injection procedure
Visual Scale for pain	Visual comparison scale for pain The scale consists of a single item, the scale is formed by a 10 cm long line on the horizontal plane. The leftmost side of the line (starting point) is scored as 0 (zero) and the rightmost side (ending point) is scored as 10 (ten) points for the highest possible pain. In order for the patient to score the pain, he/she is asked to mark a point on the line during the injection process. After marking, the distance from the starting point to the marked place is measured and the score is formed. The scale has been proven to be reliable in terms of Turkish as a result of the study conducted by Yaray et al.	during injection procedure
Visual Comparison Scale for Satisfaction	Visual Comparison Scale for Satisfaction In this scale, scores between 0 and 10 were used to determine satisfaction levels. A score of 0 represented the least satisfaction level, while a score of 10 represented the highest satisfaction level. The Visual Analog Scale was used so that patients could express both their pain and satisfaction levels.	during injection procedure

Collaborators and Investigators

• Sponsor: Trakya University

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2024
• Primary Completion (Actual): September 23, 2024
• Study Completion (Actual): September 23, 2024

Study Registration Dates

• First Submitted: February 11, 2025
• First Submitted That Met QC Criteria: February 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: pain; low molecular weight heparin; palm stimulator; extended injection time
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: TUTF-GOBAEK 202313|8

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