PainNCT06381804
Effect of Shotblocker and Palm Stimulator
A study testing shotblocker and palm stimulator in people with Pain, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
This study discusses the advancements in nursing, particularly focusing on intramuscular injections, their complications, and innovative non-pharmacological methods such as the Shotblocker and palm stimulator to reduce pain. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- shotblocker and palm stimulator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Apr 2024to 23 May 2024
- 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
- Volunteering to participate in the research,
- Those who will receive vitamin B injection ordered by physician due to B12 deficiency,
- Conscious and oriented,
- Able to understand and speak Turkish,
- Age range is between 18-65,
- Having no vision or hearing problems,
Show all 13Show fewer
- Pain score of 2 or less when evaluated with a visual analog scale,
- Able to lie in the right lateral position where injection can be administered,
- Those who have not had an IM injection into the right ventrogluteal area in the last week,
- Body mass index is within the normal range (25.0-29.9 kg/m2) according to WHO,
- Those who have not used any analgesics or muscle relaxants in the last 24 hours,
- Does not have any problems such as hardness, mass, edema or infection in the area to be injected,
- According to his own statement, he has no psychiatric diagnosis,
Who cannot join
- Having pain anywhere in the body,
- Narcotic type or different analgesic area before application,
- Pregnant or suspected of pregnancy,
- Individuals in menstrual period,
- Receiving chemotherapy and radiotherapy treatment,
- Those who have migraine, are in the postoperative period, have nerve damage, neuropathy and a vascular disease,
- Those who have disabilities in grasping their hands,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Shotblocker and Palm Stimulator in Reducing Pain Associated With Intramuscular Injection: A Randomized Controlled Trial
This study discusses the advancements in nursing, particularly focusing on intramuscular injections, their complications, and innovative non-pharmacological methods such as the Shotblocker and palm stimulator to reduce pain. These methods, based on the gate control theory, aim to minimize discomfort during injections by applying tactile stimulation, which has proven effective in various studies.
Read the detailed description
It was planned to examine the effect of shot blocker and palm stimulator use on injection-related pain during intramuscular injection.This study is a randomized controlled, single-blind, parallel group experimental study to be conducted in the emergency department of a State Hospital in Konya, Turkey. The research will be conducted on individuals who will receive intramuscular (IM) injection. Participants will be randomized and divided into Shotblocker, Palm stimulator and control groups. Data collection will run from April 2024 to May 2024 and analyzes will be conducted blinded by an independent statistician. This study aims to evaluate the effects of these techniques on pain and anxiety.
- Conditions
- Pain
- Being tested
- shotblocker, palm stimulator
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
shotblockerOther
shotblocker device
palm stimulatorOther
palm stimulator
| Study group | Role | What they receive |
|---|---|---|
| shotblocker | Experimental | shotblocker Receives: Other: shotblocker |
| palm stimulator | Experimental | palm stimulator Receives: Other: palm stimulator |
| control | No intervention | control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS) pain Scale score
The Visual analog scale (VAS) score for grading of pain consists of a 10 centimetres (cm) line with 10 mm (0.01 cm) to each point of the scale and two end-points representing no pain and worst possible pain, where 0 = no pain, 1-3 = mild, 4-6 = moderate and 7-10 = severe pain
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start19 Apr 2024
- Primary completion23 May 2024
- Study completion23 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulden Basit, Necmettin Erbakan University
- Investigators
- Gülden Basit, PhD, Study director, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381804
- Sponsor's protocol ID
- 24YL9001
- Status last verified
- May 2024
- First submitted
- 17 Apr 2024
- Last updated
- 24 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Shotblocker and Palm Stimulator in Reducing Pain Associated With Intramuscular Injection: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06381804
- Acronym / sponsor ID
- 24YL9001
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 24 Apr 2024 (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.
This study discusses the advancements in nursing, particularly focusing on intramuscular injections, their complications, and innovative non-pharmacological methods such as the Shotblocker and palm stimulator to reduce pain. These methods, based on the gate control theory, aim to minimize discomfort during injections by applying tactile stimulation, which has proven effective in various studies.
Detailed description
It was planned to examine the effect of shot blocker and palm stimulator use on injection-related pain during intramuscular injection.This study is a randomized controlled, single-blind, parallel group experimental study to be conducted in the emergency department of a State Hospital in Konya, Turkey. The research will be conducted on individuals who will receive intramuscular (IM) injection. Participants will be randomized and divided into Shotblocker, Palm stimulator and control groups. Data collection will run from April 2024 to May 2024 and analyzes will be conducted blinded by an independent statistician. This study aims to evaluate the effects of these techniques on pain and anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| shotblocker | Experimental | Other: shotblockershotblocker |
| palm stimulator | Experimental | Other: palm stimulatorpalm stimulator |
| control | No intervention | –control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Volunteering to participate in the research,
Key exclusion criteria (7 listed)
- Having pain anywhere in the body,
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 |
|---|---|---|
| shotblockershotblocker device | Other | shotblocker |
| palm stimulatorpalm stimulator | Other | palm stimulator |
Primary outcome
Visual analog scale (VAS) pain Scale score
Time frame: up to 6 weeks
The Visual analog scale (VAS) score for grading of pain consists of a 10 centimetres (cm) line with 10 mm (0.01 cm) to each point of the scale and two end-points representing no pain and worst possible pain, where 0 = no pain, 1-3 = mild, 4-6 = moderate and 7-10 = severe pain
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 24 May 2024.
- Individual participant dataSharing planned: No
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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.
Gülden Basit, PhD study director
Necmettin Erbakan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing shotblocker and palm stimulator in people with Pain, run by Necmettin Erbakan 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 13 inclusion and 7 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 24 May 2024. 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 (VAS) pain Scale score (time frame: up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2024.