NCT05456945

Brief Summary

Various non-pharmacological approaches are used in the relief of pain caused by intramuscular injection. Shotblocher and acupressure, which are among these methods, are easy to apply.More evidence-based studies are needed to fully understand the effectiveness of acupressure an d shotblocher in reducing pain associated with intramuscular injection.This study will be conducted to compare the effectiveness of shotblocker and acupressure in reducing pain associated with intramuscular injection in the emergency department.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 13, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

July 20, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2022

Completed
Last Updated

July 13, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

July 10, 2022

Last Update Submit

July 10, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Visual analog scale

    The visual analog scale will be used to assess the patient's pain intensity. It is a self-reported scale in the form of a 10-cm ruler indicating no pain at one end and unbearable pain at the other. Accordingly, the patient is told to evaluate his/her pain between 0 and 10, with 0 indicating "no pain" and 10 indicating "unbearable pain

    2 minutes

  • Verbal category scale

    The verbal category scale is a one-dimensional, simple, descriptive scale. Patients are asked to state the most appropriate word to describe their pain while filling in the scale. To describe the severity of pain, the patients had to choose from among (1) mild, (2) disturbing, (3) severe, (4) very severe, and (5) unbearable 5. The verbal category scale is a one-dimensional, simple, descriptive scale. Patients are asked to state the most appropriate word to describe their pain while filling in the scale. To describe the severity of pain, the patients had to choose from among (1) mild, (2) disturbing, (3) severe, (4) very severe, and (5) unbearable

    2 minutes

Study Arms (3)

Acupressure

EXPERIMENTAL

Before the injection, patients will be asked to lie in the prone position. The acupressure point (UB32) will be located on the side to be injected. The UB32 point is located in the sacrum region, below the medial and posterior superior iliac spine, in the second sacral foramen. The acupressure point UB32 will be pressed circularly with a stopwatch for 1 minute. Then the acupressure point will be pressed three times in sequence with the thumb directly (pressure equal to 4.5 kg/cm2). Diclofenac sodium (75mg/3ml) will be injected after acupressure.

Other: acupressure application

Shotblocher

EXPERIMENTAL

Before the injection, patients will be asked to lie in the prone position. The protruding surface of the Shotblocker will be placed in the area just before the injection so that the point of entry with the needle will not be contaminated. Pressure will be applied by keeping the Shotblocker constant throughout the process. The injector will be quickly inserted through the gap in the middle of the shortblocher. Shotblocker will be removed after drug administration.

Device: Shotblocher

Control group

NO INTERVENTION

No intervention will be applied before the injection

Interventions

Acupressure will be applied to the UB32 point

Acupressure

Shotblocher will be administered during injection

Shotblocher

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those who are admitted to the emergency room for the administration of prescription drugs or those who are planned to be injected intramuscularly by the emergency room physician
  • Diclofenac sodium (75 mg/3 ml) was ordered to the patient in the emergency department.
  • years and older
  • Patients who have not had an injection in the same area in the last 2 week
  • Having no problems with vision and hearing
  • Does not have a disease that can cause loss of sensation and sensory loss
  • Open to communication and cooperation
  • Patients willing to participate in the study will be included in the study.

You may not qualify if:

  • Those who apply to the emergency department with complaints of anxiety or trauma (soft tissue traumas, multiple traumas due to traffic accidents or falls, or bone fractures),
  • Those who experience a change in consciousness,
  • Patients with clinical conditions that require urgent intervention,
  • Infection at the injection site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal İnvestigator

Study Record Dates

First Submitted

July 10, 2022

First Posted

July 13, 2022

Study Start

July 20, 2022

Primary Completion

September 30, 2022

Study Completion

October 30, 2022

Last Updated

July 13, 2022

Record last verified: 2022-07