NCT07063160

Brief Summary

The pain that develops when the needle is inserted into the muscle in an Intramuscular injection triggers anxiety in many people and can cause a lifelong fear of Intramuscular injection. Fear related to Intramuscular injection can result in postponing or not having the injection. Injection applications can also cause an increase in pain, fear and anxiety levels in individuals and a decrease in comfort and satisfaction levels. For this reason, nurses are expected to take precautions or implement interventions that will reduce pain, increase comfort and satisfaction, and alleviate the patient's symptoms during drug administration. The use of acupressure therapy can be effective in reducing the feeling of pain and alleviating/eliminating the fear felt against the injection and thus increasing satisfaction after the injection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

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

Click on a node to explore related trials.

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
2 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

February 22, 2025

Last Update Submit

July 3, 2025

Conditions

Keywords

Intramuscular injectionAcupressure therapyPainInjection FearSatisfaction

Outcome Measures

Primary Outcomes (3)

  • Visual Analog Scale pain scores of patients in the experimental group who received acupressure treatment after intramuscular injection

    Visual Analog Scale score

    1 day

  • Injection Fear Scale scores of patients in the experimental group who received acupressure treatment after intramuscular injection

    Injection Fear Scale score

    1 day

  • Post-Injection Satisfaction Scale scores of patients in the experimental group who received acupressure treatment after intramuscular injection

    Satisfaction Scale scores

    1 day

Study Arms (2)

Intramuscular injection after acupressure therapy

EXPERIMENTAL

Before the injection is applied to the patients in the experimental group; First, the patient who filled in the Personal Information Form will first apply pressure with the thumb for 1 minute to the GB 30 point located at the junction between the medial two-thirds and the lateral one-third of a line connecting the greater trochanter and the sacral hiatus with the acupressure therapy method. Then, the Injection Fear Scale will be filled in. Then, Diclofenac Sodium injection will be applied IM. After the injection, the pain intensity will be measured with VAS and finally the Post-Injection Satisfaction Scale will be filled in.

Behavioral: PainBehavioral: Fear of injectionBehavioral: Post-injection satisfaction

Intramuscular injection after standard application

ACTIVE COMPARATOR

Before the injection to the patients in the control group; Personal Information Form and Injection Fear Scale will be filled. Then, Diclofenac Sodium injection will be applied IM without any therapy method. The patient whose pain intensity is measured with VAS after the injection will finally fill out the Injection Satisfaction Scale.

Behavioral: PainBehavioral: Fear of injectionBehavioral: Post-injection satisfaction

Interventions

PainBEHAVIORAL

Injection was used to determine the level of pain

Intramuscular injection after acupressure therapyIntramuscular injection after standard application

The scale developed determines the fear levels of individuals towards the injection procedure. The scale consists of 14 items. It was developed on a 5-point Likert type, 1-I am not afraid at all, 5- I am very afraid. The scale is calculated based on the item score average. The lowest score that can be obtained from the scale is 1, and the highest score is 5. As the score obtained from the scale increases, the level of fear increases. Stated in their research that the Cronbach Alpha value for the entire scale was 0.92.

Intramuscular injection after acupressure therapyIntramuscular injection after standard application

The scale developed to determine the satisfaction levels of patients regarding the injection process. The scale was developed in a 5-point Likert type, 1-I am not satisfied at all, 5-I am very satisfied. The scale is calculated based on the item score average. The lowest score that can be obtained from the scale is 1, and the highest score is 5. As the score obtained from the scale increases, the level of satisfaction increases. Post-injection satisfaction Scale consists of 9 items. In the study conducted, it was determined that the Cronbach Alpha value of the entire scale was 0.895.

Intramuscular injection after acupressure therapyIntramuscular injection after standard application

Eligibility Criteria

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

You may qualify if:

  • The patient must be 18 years of age or older,
  • Have the physical and mental capacity to correctly evaluate the Visual Analog Scale (VAS),
  • Have the capacity to read and understand the research guidelines,
  • Have a prescription from the physician that only requests Diclofenac Sodium by Intra Muscular,
  • Have their treatment just started,
  • Be within the normal weight-obese range according to the BMI determined by the World Health Organization,
  • Have not received Intramuscular injections from the Ventrogluteal (VG) region in the last 6 months,
  • Have no scars, scar tissue, etc. in the VG region

You may not qualify if:

  • \- Using any painkillers on the day of the injection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Mediterranean University

Mersin, - Please Select -, 34381, Turkey (Türkiye)

Location

Related Publications (6)

  • Ayinde O, Hayward RS, Ross JDC. The effect of intramuscular injection technique on injection associated pain; a systematic review and meta-analysis. PLoS One. 2021 May 3;16(5):e0250883. doi: 10.1371/journal.pone.0250883. eCollection 2021.

  • Fu Q, Xie H, Zhou L, Li X, Liu Y, Liu M, Wang C, Wang X, Wang Z, Tang J, Xiao H, Xiao Z, Zhou J, Feng C, Wang L, Ao Z, Chen X, Su C, Wu X, Zhao M, Hu S, Lin H, Huang J, Xu G, Zhang Q, Jiang L. Traditional Chinese medicine auricular point acupressure for the relief of pain, fatigue, and gastrointestinal adverse reactions after the injection of novel coronavirus-19 vaccines: a structured summary of a study protocol for a multicentre, three-arm, single-blind, prospective randomized controlled trial. Trials. 2021 Feb 25;22(1):162. doi: 10.1186/s13063-021-05138-3.

  • Sanlialp Zeyrek A, Takmak S, Kurban NK, Arslan S. Systematic review and meta-analysis: Physical-procedural interventions used to reduce pain during intramuscular injections in adults. J Adv Nurs. 2019 Dec;75(12):3346-3361. doi: 10.1111/jan.14183. Epub 2019 Sep 13.

  • Suhrabi Z, Taghinejad H. Effect of acupressure (UB32) on pain intensity in intramuscular injections. Iran J Nurs Midwifery Res. 2014 Jan;19(1):24-7.

  • Cmc S, Lord H, Vargese SS, Kurian N, Cherian SA, Mathew E, Fernandez R. Effectiveness of physical stimulation for reducing injection pain in adults receiving intramuscular injections: a systematic review and meta-analysis. JBI Evid Synth. 2023 Feb 1;21(2):373-400. doi: 10.11124/JBIES-20-00590.

  • Inangil D, Inangil G. The effect of acupressure (GB30) on intramuscular injection pain and satisfaction: Single-blind, randomised controlled study. J Clin Nurs. 2020 Apr;29(7-8):1094-1101. doi: 10.1111/jocn.15172. Epub 2020 Jan 20.

MeSH Terms

Conditions

IatrophobiaPainPersonal Satisfaction

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Msc

Study Record Dates

First Submitted

February 22, 2025

First Posted

July 14, 2025

Study Start

November 15, 2024

Primary Completion

February 20, 2025

Study Completion

February 20, 2025

Last Updated

July 14, 2025

Record last verified: 2025-07

Locations