NCT07049640

Brief Summary

The ventrogluteal injection is an invasive and often painful procedure commonly performed in healthcare settings. This study aimed to compare the effects of acupressure and cold application on pain, anxiety, comfort, and hemodynamic parameters prior to the ventrogluteal injection procedure. Research questions

  1. 1.What is the effect of acupressure and cold application to acupressure points on pain caused by the ventrogluteal injection procedure?
  2. 2.What is the effect of acupressure and cold application to acupressure points on anxiety caused by the ventrogluteal injection procedure?
  3. 3.What is the effect of acupressure and cold application to acupressure points on comfort during the ventrogluteal injection procedure?
  4. 4.What is the effect of acupressure and cold application to acupressure points on pulse rate during the ventrogluteal injection procedure?
  5. 5.What is the effect of acupressure and cold application to acupressure points on respiratory rate during the ventrogluteal injection procedure?
  6. 6.What is the effect of acupressure and cold application to acupressure points on diastolic blood pressure during the ventrogluteal injection procedure?
  7. 7.What is the effect of acupressure and cold application to acupressure points on systolic blood pressure during the ventrogluteal injection procedure?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

June 18, 2025

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

February 3, 2026

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

June 18, 2025

Last Update Submit

February 2, 2026

Conditions

Keywords

PainAnxietyComfortHemodynamic Parameters

Outcome Measures

Primary Outcomes (4)

  • NPR-Pain Scale

    The number 0 on the scale means they feel no pain or anxiety, while the number 10 represents the worst pain and the highest level of anxiety.

    "Average of 3 months"

  • NPR-Anxiety Scale

    The number 0 on the scale means they feel no pain or anxiety, while the number 10 represents the worst pain and the highest level of anxiety.

    "Average of 3 months"

  • Comfort Scale for Injection

    The lowest score that can be obtained from the scale is 1, and the highest score is 5.

    "Average of 3 months"

  • Vital Signs follow-up Form

    Systolic and Diastolic Pressure 140/90 mmHg

    "Average of 3 months"

Study Arms (3)

Acupressure group

EXPERIMENTAL

Acupressure

Other: Acupressure Group

Cold Application to Acupressure Points group

ACTIVE COMPARATOR

Cold Application to Acupressure

Other: Cold Application to Acupressure Points Group

Control group

NO INTERVENTION

Control

Interventions

Effects of Acupressure Interventions

Acupressure group

Effects of Cold Application to Acupressure Points Interventions

Cold Application to Acupressure Points group

Eligibility Criteria

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

You may qualify if:

  • years old,
  • Patients prescribed at least two doses of penicillin per day,
  • There is an indication for injection administration
  • Volunteer to participate in the research will be included.

You may not qualify if:

  • Volunteer to participate in the research will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siirt Training and Research Hospital

Siirt, Siirt, 47200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • HEDİYE ÖZBAY, PhD

    Mardin Artuklu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Acupressure Group Cold Application to Acupressure Points Group Control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hediye Utli, PhD, RN, Assistant Professor

Study Record Dates

First Submitted

June 18, 2025

First Posted

July 3, 2025

Study Start

July 1, 2025

Primary Completion

November 18, 2025

Study Completion

December 30, 2025

Last Updated

February 3, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations