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Injection FearNCT07063160

Effect of Acupressure Therapy on Pain, Fear, and Post-Injection Satisfaction in Patients Undergoing IM Injection

A study testing Pain, Fear of injection and Post-injection satisfaction in people with Injection Fear and Injection Site, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Injection Fear, Injection Site
What is being tested?
Pain, Fear of injection and Post-injection satisfaction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Nov 2024to 20 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • - Using any painkillers on the day of the injection

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Eastern Mediterranean University

    Mersin, - Please Select -, 34381

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Acupressure Therapy on Pain, Injection Fear, and Post-Injection Satisfaction in Patients Undergoing Intramuscular Injection

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.

Read the detailed description

Intramuscular (IM) injection is a parenteral drug application where large amounts of drugs are administered into the deep muscle layer. IM injections are frequently made into the Ventrogluteal (VG), Dorsogluteal (DG), Vastus Lateralis/LateroFemoral and Deltoid muscles. Studies conducted in recent years in particular have indicated that the DG region is a risky area due to its proximity to the gluteal artery and sciatic nerve, and therefore it is emphasized that it should not be preferred unless necessary. Although it is a frequently preferred application among drug administration methods, IM injections have serious risks such as "accidental administration of the drug into the vein and nerve damage, post-injection pain, ecchymosis, and swelling". One of the most common complications encountered in intramuscular injection applications is pain. Although pain is defined as a universal experience that every individual has encountered at least once in their life, there are individual differences in the perception and expression of pain. It is reported that the pain that occurs with IM injection is related to the mechanical trauma that occurs at the needle entry and the sudden pressure created by the drug while it is injected into the muscle. In IM injection applications, the patient's anxiety and fear level before the injection significantly affects the pain they feel. In IM injection applications, the pain that occurs when the needle is inserted into the muscle initiates anxiety and can also cause people to feel fear of IM injection applications throughout their lives. Due to the fear that develops due to IM injection, patients may postpone the injection application or do not have the injection. Injection applications may also cause an increase in pain, fear and anxiety levels and a decrease in comfort and satisfaction levels in individuals. 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 applications. In the literature, there are applications such as using the appropriate injection technique, positioning the patient appropriately, slowly administering the drug to the tissue, using the Z technique, applying an air lock, diverting the patient's attention, and using different alternative therapy methods to reduce the pain that occurs due to injection applications. One of these alternative therapy methods is acupressure therapy.

Acupressure therapy is a technique that aims to relieve or prevent pain by applying pressure to certain points with fingers. The physiological effect of this method is associated with the stimulation of pain modulation through different mechanisms. It is accepted that the life energy called "Chi" flows along energy channels called "meridians" in the body, which are named according to the internal organs. There are 14 meridians in the human body, 12 of which are double and 2 are single. The pressure applied to the points on these channels reduces the tension in various parts of the body and the tension in the muscles, increases the secretion of endorphins and blood circulation. Acupressure application is based on applying manual pressure to the same point with the finger and palm for approximately 1 minute.

The American Pain Management Nursing Association has emphasized that correct and effective interventions should be applied to the patient, situation, environment and needs in order to manage pain/fear/anxiety and ensure patient satisfaction before, during and after interventional applications for patients. Before the intramuscular injection, most patients are afraid because they think they will feel pain, and they postpone or do not have the medication applied. This situation causes the treatment to be interrupted and the recovery to be delayed. At this point, 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 the satisfaction after the injection. When the literature is examined, it is seen that the studies on the pain, fear of injection and the level of satisfaction after the injection in acupressure therapy in intramuscular injection applications are limited. In this context, this study was planned to examine the effect of acupressure therapy on pain, fear of injection and the level of satisfaction after the injection in patients who receive intramuscular injection.

Being tested
Pain, Fear of injection, Post-injection satisfaction
Keywords
Intramuscular injection, Acupressure therapy, Pain, Injection Fear, Satisfaction
Medical subject headings
Iatrophobia, Pain, Personal Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PainBehavioural

    Injection was used to determine the level of pain

  • Fear of injectionBehavioural

    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.

  • Post-injection satisfactionBehavioural

    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.

Study groups in NCT07063160
Study groupRoleWhat they receive
Intramuscular injection after acupressure therapyExperimentalBefore 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.
Receives: Behavioral: Pain; Behavioral: Fear of injection; Behavioral: Post-injection satisfaction
Intramuscular injection after standard applicationActive comparatorBefore 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.
Receives: Behavioral: Pain; Behavioral: Fear of injection; Behavioral: Post-injection satisfaction

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Visual Analog Scale score

    Measured: 1 day

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

    Injection Fear Scale score

    Measured: 1 day

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

    Satisfaction Scale scores

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2025
  2. Study start15 Nov 2024
  3. Primary completion20 Feb 2025
  4. Study completion20 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07063160
Sponsor's protocol ID
EasternMUonur
Status last verified
Jul 2025
First submitted
22 Feb 2025
Last updated
14 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Yes

Publications

  • 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.

    PubMed 33939726
  • 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.

    PubMed 33632286
  • 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.

    PubMed 31452229
  • 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.

    PubMed 24554956
  • 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.

    PubMed 36758552
  • 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.

    PubMed 31891437
  • Soydinc O, Cevheroglu S. Effects of Acupressure on Pain, Fear, and Satisfaction in Intramuscular Injections. Pain Manag Nurs. 2026 Aug;27(4):e701-e707. doi: 10.1016/j.pmn.2026.01.015. Epub 2026 Feb 17.

    PubMed 41708467

Questions about this trial

What is this clinical trial studying?

A study testing Pain, Fear of injection and Post-injection satisfaction in people with Injection Fear and Injection Site, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale pain scores of patients in the experimental group who received acupressure treatment after intramuscular injection (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07063160, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.

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