Intramuscular Injection PainIM-PainTechNCT07262463
Effect of Traction-Pressure-Release and Manual Pressure on Intramuscular Injection Pain
A study testing Standard Intramuscular Injection, Manual Pressure Technique and Traction-Pressure-Release (TPR) Technique in people with Intramuscular Injection Pain, run by Melek Sahin at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to evaluate whether two different intramuscular (IM) injection techniques-Manual Pressure and Traction-Pressure-Release (TPR)-can effectively reduce injection-related pain and improve patient satisfaction in adult hospitalized patients receiving diclofenac sodium (3 mL) via IM… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intramuscular Injection Pain
- What is being tested?
- Standard Intramuscular Injection, Manual Pressure Technique and Traction-Pressure-Release (TPR) Technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2024to 10 Nov 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Hospitalized in the Orthopedics, General Surgery, or Orthopedics Clinic at Servergazi State Hospital.
- Prescribed intramuscular diclofenac sodium (3 mL).
- Has not received any intramuscular injection in the previous week.
- Able to understand instructions and accurately use the Visual Analog Scale (VAS).
- Provides written informed consent.
Who cannot join
- Presence of pain, abscess, infection, tissue necrosis, hematoma, or any complication related to previous intramuscular injections at the ventrogluteal site.
- Impaired consciousness or communication difficulties.
- Visual or hearing impairment that prevents accurate scale assessment.
- Any physical condition preventing proper positioning of the extremities for IM injection.
- Declines to participate or withdraws consent at any time.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Muğla Sıtkı Koçman University, Fethiye Faculty Of Health Sciences, Department of Nursing
Muğla, Fethiye, 48300
About this study
Official title: The Effect of Traction-Pressure-Release (TPR) and Manual Pressure Methods on Intramuscular Injection Pain and Satisfaction in Adults: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate whether two different intramuscular (IM) injection techniques-Manual Pressure and Traction-Pressure-Release (TPR)-can effectively reduce injection-related pain and improve patient satisfaction in adult hospitalized patients receiving diclofenac sodium (3 mL) via IM injection.
The main questions the study aims to answer are:
Read more
Does the TPR technique reduce IM injection pain more effectively than the standard method?
Does the Manual Pressure technique reduce IM injection pain more effectively than the standard method?
How are patients' fear of injection and experienced pain related?
Since there is a comparison group, researchers will compare three arms (Control, Manual Pressure, TPR) to determine whether either technique results in lower pain scores and higher satisfaction compared with the standard IM injection procedure.
Participants will:
Receive diclofenac sodium via IM injection in the ventrogluteal site using one of three randomized techniques:
- Standard IM injection (Control)
- Manual Pressure technique
- Traction-Pressure-Release (TPR) technique
Rate their pain using the Visual Analog Scale (VAS) immediately after the injection.
Rate their satisfaction using the Injection Satisfaction Scale.
Provide demographic and clinical data through a Patient Information Form.
This study uses a single-blind randomized controlled trial design with three parallel groups. A total of 174 adult patients will be enrolled to ensure adequate power for statistical comparison.
- Conditions
- Intramuscular Injection Pain
- Being tested
- Standard Intramuscular Injection, Manual Pressure Technique, Traction-Pressure-Release (TPR) Technique
- Keywords
- Intramuscular injection, Pain, Manual pressure, TPR technique, Ventrogluteal site
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Intramuscular InjectionOther
Participants in this arm will receive the standard intramuscular (IM) injection technique without any additional intervention. The IM injection will be administered into the ventrogluteal site using a 5 mL syringe with a 21G, 38 mm needle. The injection area will be cleaned with an alcohol swab, and diclofenac sodium (3 mL) will be injected at a rate of 1 mL per 10 seconds. No manual pressure or Traction-Pressure-Release (TPR) technique is applied. Pain and satisfaction are assessed immediately after the injection using validated visual scales.
Manual Pressure TechniqueProcedure or surgery
In this intervention, firm manual pressure is applied to the ventrogluteal injection site using the non-dominant thumb for 10 seconds prior to needle insertion. After cleaning the skin with an alcohol swab, diclofenac sodium (3 mL) is injected at a rate of 1 mL per 10 seconds using a 5 mL syringe with a 21G, 38 mm needle. No traction or rapid muscle release is performed. Pain and satisfaction are measured immediately after the injection using validated visual scales.
Traction-Pressure-Release (TPR) TechniqueProcedure or surgery
In this intervention, the IM injection is administered using the Traction-Pressure-Release (TPR) technique. After preparing the site with an alcohol swab, the needle is inserted at a 90-degree angle while the non-dominant hand applies simultaneous skin traction and deep pressure to the injection site. Immediately after needle insertion, the muscle is rapidly released, followed by aspiration and injection of diclofenac sodium (3 mL) at a rate of 1 mL per 10 seconds. The dominant hand holding the syringe remains stable throughout the procedure. Pain and satisfaction are assessed immediately after the injection using validated visual scales.
| Study group | Role | What they receive |
|---|---|---|
| Standard Intramuscular Injection (Control Group) | Other | Control Group: Participants in this arm will receive the standard intramuscular (IM) injection technique without any additional intervention. The injection will be administered into the ventrogluteal site using a 5 mL syringe with a 21G, 38 mm needle. The injection area will be cleaned with an alcohol swab, and the medication (diclofenac sodium, 3 mL) will be delivered at a rate of 1 mL per 10 seconds. No manual pressure or Traction-Pressure-Release (TPR) technique will be applied. Pain and satisfaction will be assessed immediately after the injection using validated visual scales. Receives: Other: Standard Intramuscular Injection |
| Manual Pressure Technique | Experimental | Manual Pressure Group: Participants in this arm will receive the intramuscular (IM) injection using the Manual Pressure technique. Before needle insertion, the non-dominant thumb will apply firm pressure to the identified ventrogluteal injection site for 10 seconds. Following skin cleaning with an alcohol swab, diclofenac sodium (3 mL) will be injected at a rate of 1 mL per 10 seconds using a 5 mL syringe with a 21G, 38 mm needle. No traction or rapid muscle release will be applied. Pain and satisfaction will be assessed immediately after the injection using validated visual scales. Receives: Procedure: Manual Pressure Technique |
| Traction-Pressure-Release (TPR) Technique | Experimental | TPR Group: Participants in this arm will receive the intramuscular (IM) injection using the Traction-Pressure-Release (TPR) technique. After skin cleaning, the syringe is held in the dominant hand. As the needle is inserted at a 90-degree angle, the non-dominant hand simultaneously applies skin traction with deep pressure, followed by rapid muscle release. After aspiration, diclofenac sodium (3 mL) is injected at a rate of 1 mL per 10 seconds using a 21G, 38 mm needle. The dominant hand remains stable throughout. Pain and satisfaction will be measured immediately after the injection using validated visual scales. Receives: Procedure: Traction-Pressure-Release (TPR) Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity after intramuscular injection
Pain intensity will be measured using the 100-mm Visual Analog Scale (VAS), where 0 indicates "no pain" and 100 indicates "worst imaginable pain." Participants will mark their pain level immediately after the intramuscular injection. The distance (mm) from the left end of the scale to the participant's mark will be recorded as the pain score.
Measured: Immediately after injection (within 1-2 minutes)
Secondary outcomes (2)
Injection satisfaction level
Satisfaction will be measured using a 100-mm Visual Satisfaction Scale, where 0 indicates "very dissatisfied" and 100 indicates "very satisfied." Participants will mark their satisfaction immediately after the injection.
Measured: Immediately after injection (within 1-2 minutes)
Relationship between fear of injection and experienced pain
Participants' reported history of injection fear (Yes/No), recorded on the Patient Information Form, will be analyzed in relation to post-injection VAS pain scores.
Measured: Immediately after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start20 Dec 2024
- Primary completion10 Nov 2025
- Study completion10 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intramuscular Injection PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Model description
- This study uses a parallel-group, single-blind randomized controlled design with three independent arms. Participants are randomly assigned in a 1:1:1 ratio to one of the following groups: (1) Standard intramuscular injection (control), (2) Manual Pressure technique, or (3) Traction-Pressure-Release (TPR) technique. Each participant receives only one type of intervention, and no crossover or repeated interventions are applied. Outcomes (pain intensity and injection satisfaction) are measured immediately after the injection using validated visual scales. Randomization is performed using block randomization to ensure balance among groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melek Sahin
- Sponsor type
- University, hospital or other
- Collaborators
- Pamukkale University
- Responsible party
- Sponsor-investigator, Melek Sahin, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262463
- Sponsor's protocol ID
- E-60116787-020-612652
- Acronym
- IM-PainTech
- Status last verified
- Oct 2025
- First submitted
- 20 Nov 2025
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to privacy concerns and institutional policies. Only summary results will be made available.
Publications
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 31452229Cmc 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 36758552Ozturk D, Baykara ZG, Karadag A, Eyikara E. The effect of the application of manual pressure before the administration of intramuscular injections on students' perceptions of postinjection pain: a semi-experimental study. J Clin Nurs. 2017 Jun;26(11-12):1632-1638. doi: 10.1111/jocn.13530. Epub 2016 Nov 24.
PubMed 27535654Salari M, Estaji Z, Akrami R, Rad M. Comparison of skin traction, pressure, and rapid muscle release with conventional method on intramuscular injection pain: A randomized clinical trial. J Educ Health Promot. 2018 Dec 28;7:172. doi: 10.4103/jehp.jehp_216_18. eCollection 2018.
PubMed 30693308
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Traction-Pressure-Release (TPR) and Manual Pressure Methods on Intramuscular Injection Pain and Satisfaction in Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07262463
- Acronym / sponsor ID
- IM-PainTech / E-60116787-020-612652
- Conditions
- Intramuscular Injection Pain
- Keywords
- Intramuscular injection, Pain, Manual pressure, TPR technique, Ventrogluteal site
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Melek SahinUniversity, hospital or other
- Collaborators
- Pamukkale University
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate whether two different intramuscular (IM) injection techniques-Manual Pressure and Traction-Pressure-Release (TPR)-can effectively reduce injection-related pain and improve patient satisfaction in adult hospitalized patients receiving diclofenac sodium (3 mL) via IM injection.
The main questions the study aims to answer are:
Does the TPR technique reduce IM injection pain more effectively than the standard method?
Does the Manual Pressure technique reduce IM injection pain more effectively than the standard method?
How are patients' fear of injection and experienced pain related?
Since there is a comparison group, researchers will compare three arms (Control, Manual Pressure, TPR) to determine whether either technique results in lower pain scores and higher satisfaction compared with the standard IM injection procedure.
Participants will:
Receive diclofenac sodium via IM injection in the ventrogluteal site using one of three randomized techniques:
- Standard IM injection (Control)
- Manual Pressure technique
- Traction-Pressure-Release (TPR) technique
Rate their pain using the Visual Analog Scale (VAS) immediately after the injection.
Rate their satisfaction using the Injection Satisfaction Scale.
Provide demographic and clinical data through a Patient Information Form.
This study uses a single-blind randomized controlled trial design with three parallel groups. A total of 174 adult patients will be enrolled to ensure adequate power for statistical comparison.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This study uses a parallel-group, single-blind randomized controlled design with three independent arms. Participants are randomly assigned in a 1:1:1 ratio to one of the following groups: (1) Standard intramuscular injection (control), (2) Manual Pressure technique, or (3) Traction-Pressure-Release (TPR) technique. Each participant receives only one type of intervention, and no crossover or repeated interventions are applied. Outcomes (pain intensity and injection satisfaction) are measured immediately after the injection using validated visual scales. Randomization is performed using block randomization to ensure balance among groups.
| Arm | Type | Receives |
|---|---|---|
| Standard Intramuscular Injection (Control Group) | Other | Other: Standard Intramuscular InjectionControl Group: Participants in this arm will receive the standard intramuscular (IM) injection technique without any additional intervention. The injection will be administered into the ventrogluteal site using a 5 mL syringe with a 21G, 38 mm needle. The injection area will be cleaned with an alcohol swab, and the medication (diclofenac sodium, 3 mL) will be delivered at a rate of 1 mL per 10 seconds. No manual pressure or Traction-Pressure-Release (TPR) technique will be applied. Pain and satisfaction will be assessed immediately after the injection using validated visual scales. |
| Manual Pressure Technique | Experimental | Procedure: Manual Pressure TechniqueManual Pressure Group: Participants in this arm will receive the intramuscular (IM) injection using the Manual Pressure technique. Before needle insertion, the non-dominant thumb will apply firm pressure to the identified ventrogluteal injection site for 10 seconds. Following skin cleaning with an alcohol swab, diclofenac sodium (3 mL) will be injected at a rate of 1 mL per 10 seconds using a 5 mL syringe with a 21G, 38 mm needle. No traction or rapid muscle release will be applied. Pain and satisfaction will be assessed immediately after the injection using validated visual scales. |
| Traction-Pressure-Release (TPR) Technique | Experimental | Procedure: Traction-Pressure-Release (TPR) TechniqueTPR Group: Participants in this arm will receive the intramuscular (IM) injection using the Traction-Pressure-Release (TPR) technique. After skin cleaning, the syringe is held in the dominant hand. As the needle is inserted at a 90-degree angle, the non-dominant hand simultaneously applies skin traction with deep pressure, followed by rapid muscle release. After aspiration, diclofenac sodium (3 mL) is injected at a rate of 1 mL per 10 seconds using a 21G, 38 mm needle. The dominant hand remains stable throughout. Pain and satisfaction will be measured immediately after the injection using validated visual scales. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years.
- Hospitalized in the Orthopedics, General Surgery, or Orthopedics Clinic at Servergazi State Hospital.
- Prescribed intramuscular diclofenac sodium (3 mL).
- Has not received any intramuscular injection in the previous week.
- Able to understand instructions and accurately use the Visual Analog Scale (VAS).
Key exclusion criteria (5 listed)
- Presence of pain, abscess, infection, tissue necrosis, hematoma, or any complication related to previous intramuscular injections at the ventrogluteal site.
- Impaired consciousness or communication difficulties.
- Visual or hearing impairment that prevents accurate scale assessment.
- Any physical condition preventing proper positioning of the extremities for IM injection.
- Declines to participate or withdraws consent at any time.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Intramuscular InjectionParticipants in this arm will receive the standard intramuscular (IM) injection technique without any additional intervention. The IM injection will be administered into the ventrogluteal site using a 5 mL syringe with a 21G, 38 mm needle. The injection area will be cleaned with an alcohol swab, and diclofenac sodium (3 mL) will be injected at a rate of 1 mL per 10 seconds. No manual pressure or Traction-Pressure-Release (TPR) technique is applied. Pain and satisfaction are assessed immediately after the injection using validated visual scales. | Other | Standard Intramuscular Injection (Control Group) |
| Manual Pressure TechniqueIn this intervention, firm manual pressure is applied to the ventrogluteal injection site using the non-dominant thumb for 10 seconds prior to needle insertion. After cleaning the skin with an alcohol swab, diclofenac sodium (3 mL) is injected at a rate of 1 mL per 10 seconds using a 5 mL syringe with a 21G, 38 mm needle. No traction or rapid muscle release is performed. Pain and satisfaction are measured immediately after the injection using validated visual scales. | Procedure or surgery | Manual Pressure Technique |
| Traction-Pressure-Release (TPR) TechniqueIn this intervention, the IM injection is administered using the Traction-Pressure-Release (TPR) technique. After preparing the site with an alcohol swab, the needle is inserted at a 90-degree angle while the non-dominant hand applies simultaneous skin traction and deep pressure to the injection site. Immediately after needle insertion, the muscle is rapidly released, followed by aspiration and injection of diclofenac sodium (3 mL) at a rate of 1 mL per 10 seconds. The dominant hand holding the syringe remains stable throughout the procedure. Pain and satisfaction are assessed immediately after the injection using validated visual scales. | Procedure or surgery | Traction-Pressure-Release (TPR) Technique |
Primary outcome
Pain intensity after intramuscular injection
Time frame: Immediately after injection (within 1-2 minutes)
Pain intensity will be measured using the 100-mm Visual Analog Scale (VAS), where 0 indicates "no pain" and 100 indicates "worst imaginable pain." Participants will mark their pain level immediately after the intramuscular injection. The distance (mm) from the left end of the scale to the participant's mark will be recorded as the pain score.
2 secondary outcomes
Injection satisfaction level
Time frame: Immediately after injection (within 1-2 minutes)
Relationship between fear of injection and experienced pain
Time frame: Immediately after injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Results publication: PubMed 31452229Sanlialp 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.
- Results publication: PubMed 36758552Cmc 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.
- Results publication: PubMed 27535654Ozturk D, Baykara ZG, Karadag A, Eyikara E. The effect of the application of manual pressure before the administration of intramuscular injections on students' perceptions of postinjection pain: a semi-experimental study. J Clin Nurs. 2017 Jun;26(11-12):1632-1638. doi: 10.1111/jocn.13530. Epub 2016 Nov 24.
- Results publication: PubMed 30693308Salari M, Estaji Z, Akrami R, Rad M. Comparison of skin traction, pressure, and rapid muscle release with conventional method on intramuscular injection pain: A randomized clinical trial. J Educ Health Promot. 2018 Dec 28;7:172. doi: 10.4103/jehp.jehp_216_18. eCollection 2018.
- Individual participant dataSharing planned: No. IPD will not be shared due to privacy concerns and institutional policies. Only summary results will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Intramuscular Injection, Manual Pressure Technique and Traction-Pressure-Release (TPR) Technique in people with Intramuscular Injection Pain, run by Melek Sahin 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 6 inclusion and 5 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 3 Dec 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?
Pain intensity after intramuscular injection (time frame: Immediately after injection (within 1-2 minutes)). 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 NCT07262463, which also lists 4 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 3 Dec 2025.