- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07505992
Acupressure for Pain, Injection Fear, and Satisfaction in Intramuscular Injection Patients
Effect of Acupressure Therapy on Pain, Injection Fear, and Post-Injection Satisfaction in Patients Undergoing Intramuscular Injection: A Randomized Controlled Trial
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Famagusta, Cyprus, 34381
- Eastern Mediterranean University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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,
Exclusion Criteria:
Patients who had taken any analgesic medications on the day of injection were excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: acupressure group
acupressure
|
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.
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No Intervention: Control group
Standard injection procedure was performed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: 1 day
|
There is a significant difference in visual analog scale pain scores between patients in the acupressure group and those in the control group. 1 represents the lowest level of pain, and 10 represents the highest level of pain.
As the number increases, the intensity of the pain also increases.
|
1 day
|
|
Fear Scale
Time Frame: 1 day
|
There is a significant difference in injection fear scale scores between patients in the acupressure group and those in the control group.
The scale is calculated based on the average item score.
The lowest possible score on the scale is 1, and the highest is 5.
As the score on the scale increases, the level of fear increases.
|
1 day
|
|
postinjection satisfaction scale
Time Frame: 1 day
|
There is a significant difference in postinjection satisfaction scale scores between patients in the acupressure group and those in the control group.
The lowest possible score on the scale is 1, and the highest is 5.
As the score on the scale increases, the level of satisfaction increases.
The Post-Injection Satisfaction Scale consists of 9 items.
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Seda C Cevheroglu, Assit. Prof, Eastern Mediterranean University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Doğu Akdeniz Üniversitesi
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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