Effect of Shotblocker and Palm Stimulator

NCT ID: NCT06381804

Last Updated: 2024-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-19

Study Completion Date

2024-05-23

Brief Summary

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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

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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shotblocker

shotblocker

Group Type EXPERIMENTAL

shotblocker

Intervention Type OTHER

shotblocker device

palm stimulator

palm stimulator

Group Type EXPERIMENTAL

palm stimulator

Intervention Type OTHER

palm stimulator

control

control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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shotblocker

shotblocker device

Intervention Type OTHER

palm stimulator

palm stimulator

Intervention Type OTHER

Eligibility Criteria

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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,
* Those who have not used any analgesics or muscle relaxants in the last 24 hours,
* Does not have any problems such as hardness, mass, edema or infection in the area to be injected,
* According to his own statement, he has no psychiatric diagnosis,

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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Necmettin Erbakan University

OTHER

Sponsor Role lead

Responsible Party

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Gulden Basit

Assist. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gülden Basit, PhD

Role: STUDY_DIRECTOR

Necmettin Erbakan University

Locations

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Necmettin Erbakan University

Meram, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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24YL9001

Identifier Type: -

Identifier Source: org_study_id

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