Effect of Shotblocker and Palm Stimulator | NCT06381804

Studies
Effect of Shotblocker and Palm Stimulator

NCT06381804

Sponsor

Necmettin Erbakan University

Status

Completed

Last Update Posted

May 24, 2024Actual

Enrollment

96Actual

Phase

Not Applicable

Conditions

Pain

Interventions

shotblocker
palm stimulator

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 19, 2024Actual

Primary Completion Date

May 23, 2024Actual

Completion Date

May 23, 2024Actual

First Submitted Date

Apr 17, 2024

First Submission Date that Met QC Criteria

Apr 19, 2024

First Posted Date

Apr 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2024

Last Update Posted Date

May 24, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

96Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
shotblocker	Experimental	shotblocker	Other: shotblocker
palm stimulator	Experimental	palm stimulator	Other: palm stimulator
control	No Intervention	control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
shotblocker	Other	shotblocker device	shotblocker
palm stimulator

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual analog scale (VAS) pain Scale score	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	up to 6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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,
- 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,

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Gülden Basit, PhD	Necmettin Erbakan University	Study Director

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms