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Clinical Trials/NCT06381804
NCT06381804
Completed
Not Applicable

Effect of Shotblocker and Palm Stimulator in Reducing Pain Associated With Intramuscular Injection: A Randomized Controlled Trial

Necmettin Erbakan University1 site in 1 country96 target enrollmentApril 19, 2024
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Necmettin Erbakan University
Enrollment
96
Locations
1
Primary Endpoint
Visual analog scale (VAS) pain Scale score
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study discusses the advancements in nursing, particularly focusing on intramuscular injections, their complications, and innovative non-pharmacological methods such as the Shotblocker and palm stimulator to reduce pain. These methods, based on the gate control theory, aim to minimize discomfort during injections by applying tactile stimulation, which has proven effective in various studies.

Detailed Description

It was planned to examine the effect of shot blocker and palm stimulator use on injection-related pain during intramuscular injection.This study is a randomized controlled, single-blind, parallel group experimental study to be conducted in the emergency department of a State Hospital in Konya, Turkey. The research will be conducted on individuals who will receive intramuscular (IM) injection. Participants will be randomized and divided into Shotblocker, Palm stimulator and control groups. Data collection will run from April 2024 to May 2024 and analyzes will be conducted blinded by an independent statistician. This study aims to evaluate the effects of these techniques on pain and anxiety.

Registry
clinicaltrials.gov
Start Date
April 19, 2024
End Date
May 23, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gulden Basit

Assist. Prof.

Necmettin Erbakan University

Eligibility Criteria

Inclusion Criteria

  • Volunteering to participate in the research,
  • Those who will receive vitamin B injection ordered by physician due to B12 deficiency,
  • Conscious and oriented,
  • Able to understand and speak Turkish,
  • Age range is between 18-65,
  • Having no vision or hearing problems,
  • Pain score of 2 or less when evaluated with a visual analog scale,
  • Able to lie in the right lateral position where injection can be administered,
  • Those who have not had an IM injection into the right ventrogluteal area in the last week,
  • Body mass index is within the normal range (25.0-29.9 kg/m2) according to WHO,

Exclusion Criteria

  • Having pain anywhere in the body,
  • Narcotic type or different analgesic area before application,
  • Pregnant or suspected of pregnancy,
  • Individuals in menstrual period,
  • Receiving chemotherapy and radiotherapy treatment,
  • Those who have migraine, are in the postoperative period, have nerve damage, neuropathy and a vascular disease,
  • Those who have disabilities in grasping their hands,

Outcomes

Primary Outcomes

Visual analog scale (VAS) pain Scale score

Time Frame: up to 6 weeks

The Visual analog scale (VAS) score for grading of pain consists of a 10 centimetres (cm) line with 10 mm (0.01 cm) to each point of the scale and two end-points representing no pain and worst possible pain, where 0 = no pain, 1-3 = mild, 4-6 = moderate and 7-10 = severe pain

Study Sites (1)

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