NCT07505992

Brief Summary

Background: Intramuscular (IM) injection-related pain and anxiety continue to be common problems in nursing practice. Non-pharmacological interventions such as acupressure are increasingly recognized for their potential to reduce procedure-related discomfort and enhance patient satisfaction. Aim: This study is planned to evaluate the effects of acupressure therapy on pain, injection-related fear, and post-injection satisfaction among patients receiving IM injections. Methods: This study is designed as a randomized controlled trial to be conducted with 68 patients presenting to the emergency department and requiring IM diclofenac sodium injection. Participants will be randomly assigned to either an intervention group (n = 34), which will receive acupressure at the GB30 (Huantiao) point prior to injection, or a control group (n = 34), which will receive standard care. Data will be collected using the Visual Analog Scale, Injection Fear Scale, and Post-Injection Satisfaction Scale.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 15, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 24, 2026

Last Update Submit

March 29, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Scale

    There is a significant difference in visual analog scale (VAS) pain scores between patients in the acupressure group and those in the control group

    1 day

  • Fear Scale

    There is a significant difference in injection fear scale (IFS) scores between patients in the acupressure group and those in the control group.

    1 day

  • postinjection satisfaction scale

    There is a significant difference in postinjection satisfaction scale (PISS) scores between patients in the acupressure group and those in the control group.

    1 day

Study Arms (2)

acupressure group

EXPERIMENTAL

acupressure

Other: acupressure

Control group

NO INTERVENTION

Standard injection procedure was performed.

Interventions

Acupressure was applied to the GB30 point, which is anatomically located at the junction of the lateral one- third and medial two-thirds of the distance between the greater trochanter of the femur and the sacral hiatus. Pressure was applied using the thumb at an intensity sufficient to produce slight skin blanching without causing pain, consistent with previously published acupressure protocols. The pressure was applied continuously for 1 minute immediately prior to the IM injection. To ensure consistency and standardization, all acupressure applications were performed by the same researcher following a predefined protocol. Participants in the control group received routine IM injection care without acupressure intervention.

acupressure group

Eligibility Criteria

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

You may qualify if:

  • Were aged 18 years or older,
  • Possessed sufficient physical and cognitive abilities to assess pain using the VAS,
  • Had the ability to read and comprehend study instructions,
  • Were newly prescribed IM Diclofenac Sodium (without prior doses),
  • Had a body mass index within the normal or obese range ac- cording to WHO classification,
  • Had no scars, wounds,

You may not qualify if:

  • Patients who had taken any analgesic medications on the day of injection were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Famagusta, 34381, Cyprus

Location

MeSH Terms

Conditions

PainPersonal Satisfaction

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Seda C Cevheroglu, Assit. Prof

    Eastern Mediterranean University

    STUDY DIRECTOR

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
Assit. Prof. Dr.

Study Record Dates

First Submitted

March 24, 2026

First Posted

April 1, 2026

Study Start

November 15, 2024

Primary Completion

February 20, 2025

Study Completion

February 20, 2025

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations