PainNCT04594083
Two Different Tactile Stimulus Methods
A study testing Palm Stimulator and ShotBlocker in people with Pain, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to evaluate the effects of the ShotBlocker and Palm Stimulator, developed by researchers for reducing pain during intramuscular (IM) injections in children. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Palm Stimulator and ShotBlocker
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2019to 7 Feb 2020
- 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- had no diagnosed physical or mental disability or chronic illness;
- had no communication problems;
- received single injection,
- required Ampicillin + Sulbactam group of antibiotics for standardization; and
- received ventrogluteal muscle injection during the study.
Who cannot join
- Parents who were unable to collaborate in the fear and pain evaluation,
- overweight or underweight children (under the third or above the 97th percentile),
- children with any incision or scar tissue in the injection area,
- children who received a sedative, analgesic, or narcotic drugs (based on expert opinion) six hours before the procedure on the basis of parental statements and medical history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Two Different Tactile Stimulus Methods on Reducing Pain
This study was conducted to evaluate the effects of the ShotBlocker and Palm Stimulator, developed by researchers for reducing pain during intramuscular (IM) injections in children.
Read the detailed description
Objectives: This study was conducted to evaluate the effects of the ShotBlocker and Palm Stimulator, developed by researchers for reducing pain during intramuscular (IM) injections in children.
Design: The study was conducted via a randomized controlled design. Setting: The study population consisted of children in the seven to 10 age group admitted to the emergency department of a public hospital (Kahta State Hospital) between February 2019 and July 2019 and who received an IM injection as part of the medical treatment.
Interventions: The study data were collected from the children, who were divided into Palm Stimulator, ShotBlocker, and control groups.
Main outcome measures: The children's pre-procedure fear levels were evaluated using the Children's Fear Scale (CFS), and their pain levels during the procedure were evaluated using the Facial Pain Scale-Revised (FPS-R). The children also reported injection-related pain levels using the Visual Analog Scale (VAS).
- Conditions
- Pain
- Being tested
- Palm Stimulator, ShotBlocker
- Keywords
- pain management, child, nursing practice, Intramuscular Injection
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palm StimulatorDevice
The Palm Stimulator, developed by the present researchers for the first time, is 1.6 cm in diameter, 4 cm in length, and has a cylindrical, non-slippery structure for an easy grip to ensure maximum contact with the palm The Palm Stimulator consists of blunt protrusions that will provide a tactile stimulus on the palm. The blunt protrusions do not penetrate into the skin. The simulator design is based on the gate-control theory, which allows for a reduction in the perceived amount of pain experienced during injection by closing the pain gate in the spinal cord in creating a stimulus on the skin.
ShotBlockerDevice
ShotBlocker was placed in the ventrogluteal area properly 20 seconds before injection. It was fixed at the injection site until the injection process was completed.
| Study group | Role | What they receive |
|---|---|---|
| Palm Stimulator | Experimental | The Palm Stimulator was placed in the palm of the child's active hand 20 seconds before the injection. It ensured by researcher that the apparatus was held tightly in the child's palm throughout the procedure. The apparatus was taken back from the child after completing the injection process. Receives: Device: Palm Stimulator |
| ShotBlocker | Experimental | ShotBlocker was placed in the ventrogluteal area properly 20 seconds before injection. It was fixed at the injection site until the injection process was completed. Receives: Device: ShotBlocker |
| Control | No intervention | The routine IM injection was applied to the children in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children's Fear Scale (CFS)
The Children's Fear Scale (CFS) is a scale used to assess the level of anxiety in children. The scale is a visual measurement tool with scores ranging from 0-4 points. It consists of five facial expressions, ranging from a neutral to a frightened expression, and is suitable for use with children aged 5-10 years (Inan \& Inal, 2019; McMurtry, Noel, Chambers, \& McGrath, 2011; Özalp Gerçeker, Ayar, Özdemir, \& Bektaş, 2018). The evaluation of the Turkish psychometric properties of the scale, which was developed by McMurty et al. for paediatric patients, was conducted by Özalp Gerçeker et al. (2018), and the scale was translated into the Turkish language (Özalp Gerçeker et al., 2018). The CFS has demonstrated good evidence of test-retest (r = 0.76, p < 0.001), and inter-rater (0.51, P < 0.001) reliability, as well as construct validity, (rs ¼ when used with children (McMurtry vd., 2011).
Measured: 5 months
Faces Pain Scale-Revised (FPS-R)
The Faces Pain Scale-Revised (FPS) is a scale used to assess the level of pain in children in the 4-12 age group (Hicks, Von Baeyer, Spafford, Van Korlaar, \& Goodenough, 2001). There are facial expressions that show the increasing levels of pain severity from left to right in the scale. Rated according to the severity of pain (between 0-10 points), the leftmost face refers to "no pain", and the rightmost face refers to "too much pain", comprising a total of six facial expressions. The faces exhibit an increase in pain severity to correspond with the scores 0, 2, 4, 6, 8, and 10 from left to right, respectively (Mohamed Mohamed Tork, 2017).
Measured: 5 months
Visual Analog Scale (VAS)
The VAS consists of a horizontal or vertical ruler 10 cm/100 mm in length, with the phrase "no pain" on one end and "the worst pain imaginable" on the other. The child is asked to mark the point on this line that most accurately reflects his/her pain. The distance between the child's mark and the left end of the scale is measured in cm and recorded as "points". It has been suggested that the widely researched scale should be used for children aged seven and older (Çelik \& Khorshid, 2015; Sivri Bilgen \& Balcı, 2019).
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start1 Feb 2019
- Primary completion1 Jul 2019
- Study completion7 Feb 2020
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, and experimental design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mürşide Zengin, Adiyaman University Research Hospital
- Investigators
- Mürşide Zengin, Principal investigator, Adiyaman UniversityEmriye Hilal Yayan, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594083
- Sponsor's protocol ID
- 2018/146
- Status last verified
- Nov 2020
- First submitted
- 14 Oct 2020
- Last updated
- 14 Jan 2021
- 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 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Different Tactile Stimulus Methods on Reducing Pain
- ClinicalTrials.gov ID
- NCT04594083
- Acronym / sponsor ID
- 2018/146
- Conditions
- Pain
- Keywords
- pain management, child, nursing practice, Intramuscular Injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 7 Feb 2020 (actual)
- First posted
- 20 Oct 2020 (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 was conducted to evaluate the effects of the ShotBlocker and Palm Stimulator, developed by researchers for reducing pain during intramuscular (IM) injections in children.
Detailed description
Objectives: This study was conducted to evaluate the effects of the ShotBlocker and Palm Stimulator, developed by researchers for reducing pain during intramuscular (IM) injections in children.
Design: The study was conducted via a randomized controlled design. Setting: The study population consisted of children in the seven to 10 age group admitted to the emergency department of a public hospital (Kahta State Hospital) between February 2019 and July 2019 and who received an IM injection as part of the medical treatment.
Interventions: The study data were collected from the children, who were divided into Palm Stimulator, ShotBlocker, and control groups.
Main outcome measures: The children's pre-procedure fear levels were evaluated using the Children's Fear Scale (CFS), and their pain levels during the procedure were evaluated using the Facial Pain Scale-Revised (FPS-R). The children also reported injection-related pain levels using the Visual Analog Scale (VAS).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomized, controlled, and experimental design
| Arm | Type | Receives |
|---|---|---|
| Palm Stimulator | Experimental | Device: Palm StimulatorThe Palm Stimulator was placed in the palm of the child's active hand 20 seconds before the injection. It ensured by researcher that the apparatus was held tightly in the child's palm throughout the procedure. The apparatus was taken back from the child after completing the injection process. |
| ShotBlocker | Experimental | Device: ShotBlockerShotBlocker was placed in the ventrogluteal area properly 20 seconds before injection. It was fixed at the injection site until the injection process was completed. |
| Control | No intervention | –The routine IM injection was applied to the children in the control group. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- had no diagnosed physical or mental disability or chronic illness;
- had no communication problems;
- received single injection,
- required Ampicillin + Sulbactam group of antibiotics for standardization; and
- received ventrogluteal muscle injection during the study.
Key exclusion criteria (4 listed)
- Parents who were unable to collaborate in the fear and pain evaluation,
- overweight or underweight children (under the third or above the 97th percentile),
- children with any incision or scar tissue in the injection area,
- children who received a sedative, analgesic, or narcotic drugs (based on expert opinion) six hours before the procedure on the basis of parental statements and medical history
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 |
|---|---|---|
| Palm StimulatorThe Palm Stimulator, developed by the present researchers for the first time, is 1.6 cm in diameter, 4 cm in length, and has a cylindrical, non-slippery structure for an easy grip to ensure maximum contact with the palm The Palm Stimulator consists of blunt protrusions that will provide a tactile stimulus on the palm. The blunt protrusions do not penetrate into the skin. The simulator design is based on the gate-control theory, which allows for a reduction in the perceived amount of pain experienced during injection by closing the pain gate in the spinal cord in creating a stimulus on the skin. | Device | Palm Stimulator |
| ShotBlockerShotBlocker was placed in the ventrogluteal area properly 20 seconds before injection. It was fixed at the injection site until the injection process was completed. | Device | ShotBlocker |
Primary outcome
Children's Fear Scale (CFS)
Time frame: 5 months
The Children's Fear Scale (CFS) is a scale used to assess the level of anxiety in children. The scale is a visual measurement tool with scores ranging from 0-4 points. It consists of five facial expressions, ranging from a neutral to a frightened expression, and is suitable for use with children aged 5-10 years (Inan \& Inal, 2019; McMurtry, Noel, Chambers, \& McGrath, 2011; Özalp Gerçeker, Ayar, Özdemir, \& Bektaş, 2018). The evaluation of the Turkish psychometric properties of the scale, which was developed by McMurty et al. for paediatric patients, was conducted by Özalp Gerçeker et al. (2018), and the scale was translated into the Turkish language (Özalp Gerçeker et al., 2018). The CFS has demonstrated good evidence of test-retest (r = 0.76, p < 0.001), and inter-rater (0.51, P < 0.001) reliability, as well as construct validity, (rs ¼ when used with children (McMurtry vd., 2011).
Faces Pain Scale-Revised (FPS-R)
Time frame: 5 months
The Faces Pain Scale-Revised (FPS) is a scale used to assess the level of pain in children in the 4-12 age group (Hicks, Von Baeyer, Spafford, Van Korlaar, \& Goodenough, 2001). There are facial expressions that show the increasing levels of pain severity from left to right in the scale. Rated according to the severity of pain (between 0-10 points), the leftmost face refers to "no pain", and the rightmost face refers to "too much pain", comprising a total of six facial expressions. The faces exhibit an increase in pain severity to correspond with the scores 0, 2, 4, 6, 8, and 10 from left to right, respectively (Mohamed Mohamed Tork, 2017).
Visual Analog Scale (VAS)
Time frame: 5 months
The VAS consists of a horizontal or vertical ruler 10 cm/100 mm in length, with the phrase "no pain" on one end and "the worst pain imaginable" on the other. The child is asked to mark the point on this line that most accurately reflects his/her pain. The distance between the child's mark and the left end of the scale is measured in cm and recorded as "points". It has been suggested that the widely researched scale should be used for children aged seven and older (Çelik \& Khorshid, 2015; Sivri Bilgen \& Balcı, 2019).
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 14 Jan 2021.
- 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.
Mürşide Zengin principal investigator
Adiyaman University
Emriye Hilal Yayan principal investigator
Inonu 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 Palm Stimulator and ShotBlocker in people with Pain, run by Adiyaman University Research Hospital 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 5 inclusion and 4 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 Jan 2021. 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?
Children's Fear Scale (CFS) (time frame: 5 months). 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?
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 Jan 2021.