Effect of Different Subcutaneous Injection Methods on Pain and Satisfaction

NCT06829407 | Completed

• 1 other identifier: TUTF-GOBAEK 202313|8
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Acute; Injection Site

Keywords

pain; low molecular weight heparin; palm stimulator; extended injection time

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

injection time

EXPERIMENTAL

The application will be done by injecting for 30 seconds and then waiting for 10 seconds and ending the process.

Other: injection time

palm stimulator

EXPERIMENTAL

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

injection time and palm stimulator

EXPERIMENTAL

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

control group

NO INTERVENTION

The injection process will last 10 seconds and the process will be terminated after waiting 10 seconds.

Interventions

injection time OTHER

give an injection

injection time

palm stimulator OTHER

give an injection

palm stimulator

injection time and palm stimulator OTHER

give an injection

injection time and palm stimulator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya Üniversitesi

Edirne, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Model Details: this study is an experimental, parallel-group (intervention-control), randomized controlled design

Study Record Dates

• First Submitted: February 11, 2025
• First Posted: February 17, 2025
• Study Start: August 20, 2024
• Primary Completion: September 23, 2024
• Study Completion: September 23, 2024
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)