Pain, AcuteNCT05250804
The Effect of Helfer Skin Tap Technique on Pain, Fear, and Anxiety in Children Undergoing Intramuscular Injection
A study testing Helfer Skin Tap Technique in people with Pain, Acute and Fear Anxiety, run by Aylin Kurt at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to examine the effect of the Helfer Skin Tapping technique on pain, fear, and anxiety in children who received intramuscular injections. The research hypotheses are as follows: H0: There is no significant difference between the intervention group and the the control group in the mean score of… Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Pain, Acute, Fear Anxiety, Child, Only
- What is being tested?
- Helfer Skin Tap Technique
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2022to 12 Jul 2022
- 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child is between the ages of 4-10
- The child's application to the Pediatric Emergency Unit
- Parent and child agreeing to participate in the project
- Absence of speech and visual impairment of the child and his parents
Who cannot join
- The child is not between the ages of 4-10
- The child's application to another department except for the Pediatric Emergency Unit
- Parent and child not agreeing to participate in the project
- Having speech and visual impairment of the child and his parents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Helfer Skin Tap Technique on Pain, Fear, and Anxiety in Children Undergoing Intramuscular Injection: Randomized Controlled Trial
The aim of this study was to examine the effect of the Helfer Skin Tapping technique on pain, fear, and anxiety in children who received intramuscular injections.
The research hypotheses are as follows:
Read more
H0: There is no significant difference between the intervention group and the the control group in the mean score of the "Wong-Baker FACES Pain Rating Scale", "Child Fear Scale", and "Child Anxiety Scale-State" during and after the Helfer Skin Tapping technique.
H1: During and after the Helfer Skin Tapping technique, the mean score of the "Wong-Baker FACES Pain Rating Scale", "Child Fear Scale", and "Child Anxiety Scale-State" is significantly lower in the intervention group compared to the control group.
Read the detailed description
In this study, there will be two groups as the intervention (who will receive an intramuscular injection with the Helfer Skin Tapping technique) and the control group (who will receive an intramuscular injection with Routine Technique). A power analysis was performed based on the number of children in both groups, based on another study using the scales to be used in the research. According to the calculations made in the G-Power 3.1 Demo package program, when the effect size was accepted as 0.8, it was seen that at least 32 cases in each group would be sufficient for 80% power. Children who meet the research criteria will be randomly assigned to the intervention and control groups via http://www.randomize.org/ by assigning a number to the order of arrival at the hospital. The intramuscular injection will be applied to both the intervention and control groups. The children in the intervention group will receive an intramuscular injection with the Helfer Skin Tapping technique and the control group will receive an intramuscular injection with Routine Technique in the pediatric emergency service. A researcher and a nurse were employed for the intramuscular injection both for the intervention and control groups. A pediatric nurse performed the intramuscular injection for all children and the other researcher helped the children to assess their pain, fear, and anxiety level. Pain, fear, and anxiety in children were evaluated by the children and their parents before, during, 5 minute after the procedure. The intramuscular injection will be performed by the same nurse both in the intervention and control groups.
- Conditions
- Pain, Acute, Fear Anxiety, Child, Only, Injection Site
- Being tested
- Helfer Skin Tap Technique
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helfer Skin Tap TechniqueOther
Helfer Skin Tap Technique is a technique in which the researcher taps the Dorso gluteal muscle by counting 1-15 with the palmar aspect of fingers (non-dominant hand) in rhythmic manner before inserting the injection intra muscularly at 90 degree and remove the needle quickly again by tapping and counting 1-3.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | All registered participants in the intervention group, will receive the intramuscular injection with Helfer Skin Tap Technique. Receives: Other: Helfer Skin Tap Technique |
| No intervention | No intervention | All registered participants in the intervention group, will receive the intramuscular injection with Routine Technique. Routine Technique involved inserting the injection intra muscularly at 90 degree angle into Dorso gluteal muscles without tapping after cleaning with alcohol swab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of the mean score of the "Wong Baker FACES Pain Rating Scale" between intervention and control groups
"Wong Baker FACES Pain Rating Scale" will be completed intramuscular injection with Helfer Skin Tap Technique that gathers quantitative data that will pain about intramuscular injection in children. A minimum of 0 points and a maximum of 10 points can be obtained from the scale. The higher scores mean the higher pain. This scale will also be completed at during and 5. minutes after the intervention. The quantitative data will be used to measure a change in the children's pain level before, and after the proposed intervention. The scale will be made with Routine Technique in the control group. At the end of the study, the change of the mean score of "Wong-Baker FACES Pain Rating Scale" between intervention and control groups will be examined. Data will be analyzed using Statistical Package for the Social Sciences package program.
Measured: 12 months
Difference between the mean score of the "Child Fear Scale" between intervention and control groups
"The Child Fear Scale" will be completed intramuscular injection with Helfer Skin Tap Technique that gathers quantitative data that will fear about the intramuscular injection in children. A minimum of 0 points and a maximum of 20 points can be obtained from the scale. The higher scores mean the higher fear. This scale will also be completed at during and 5 minutes after the intervention. The quantitative data will be used to measure a change in the children's fear level before, and after the proposed intervention. The scale will be made with Routine Technique in the control group. At the end of the study, the change of the mean score of "The Child Fear Scale" between intervention and control groups will be examined. Data will be analyzed using Statistical Package for the Social Sciences package program.
Measured: 12 months
Difference between the mean score of the "Child Anxiety Meter-State" between intervention and control groups
"The Child Anxiety Meter-State" will be completed intramuscular injection with Helfer Skin Tap Technique that gathers quantitative data that will anxiety about the intramuscular injection in children. A minimum of 0 points and a maximum of 10 points can be obtained from the scale. The higher scores mean the higher anxiety. This scale will also be completed at during and 5 minutes after the intervention. The quantitative data will be used to measure a change in the children's anxiety level before and after the proposed intervention. The scale will be made with Routine Technique in the control group. At the end of the study, the change of the mean score of "The Child Anxiety Meter-State" between intervention and control groups will be examined. The Child Anxiety Meter-State total score mean of the children in the intervention group will be lower after the intervention compared to the control group. Data will be analyzed using Statistical Package for the Social Sciences package program.
Measured: 12 months
Secondary outcomes (3)
Change of the mean scores obtained by the children in the intervention group from the "Wong Baker FACES Pain Rating Scale" before and after the intervention.
"The Wong Baker FACES Pain Rating Scale" will be completed before intramuscular injection with Helfer Skin Tap Technique that gathers quantitative data that will address pain about the inhaler treatment with a nebulizer in children.A minimum of 0 points and a maximum of 10 points can be obtained from the scale. The higher scores mean the higher pain. This scale will also be completed at the intervention during and during and 5 minutes after the intervention. The quantitative data will be used to measure the change in the children's pain before, and after the proposed intervention. Data will be analyzed using Statistical Package for the Social Sciences package program.
Measured: 12 months
Change of the mean scores obtained by the children in the intervention group from the "Child Fear Scale" before and after the intervention.
"The Child Fear Scale" will be completed before intramuscular injection with Helfer Skin Tap Technique that gathers quantitative data that will address fear about the inhaler treatment with a nebulizer in children. A minimum of 0 points and a maximum of 20 points can be obtained from the scale. The higher scores mean the higher fear. This scale will also be completed at the intervention during and 1. minutes after the intervention. The quantitative data will be used to measure the change in the children's fear before, and after the proposed intervention. Data will be analyzed using Statistical Package for the Social Sciences package program.
Measured: 12 months
Change of the mean scores obtained by the children in the intervention group from the " Child Anxiety Meter-State " before and after the intervention.
"The Child Anxiety Meter-State" will be completed before intramuscular injection with Helfer Skin Tap Technique that gathers quantitative data that will address anxiety about the inhaler treatment with a nebulizer in children. A minimum of 0 points and a maximum of 10 points can be obtained from the scale. The higher scores mean the higher anxiety. This scale will also be completed at the intervention during and 1. minutes after the intervention. The quantitative data will be used to measure the change in the children's anxiety before, and after the proposed intervention. Data will be analyzed using Statistical Package for the Social Sciences package program.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start28 Feb 2022
- Primary completion12 Jul 2022
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aylin Kurt
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aylin Kurt, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05250804
- Sponsor's protocol ID
- 2021-SBB-0513
- Status last verified
- May 2023
- First submitted
- 28 Jan 2022
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Helfer Skin Tap Technique on Pain, Fear, and Anxiety in Children Undergoing Intramuscular Injection: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05250804
- Acronym / sponsor ID
- 2021-SBB-0513
- Conditions
- Pain, Acute, Fear Anxiety, Child, Only, Injection Site
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Aylin KurtUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 22 Feb 2022 (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 aim of this study was to examine the effect of the Helfer Skin Tapping technique on pain, fear, and anxiety in children who received intramuscular injections.
The research hypotheses are as follows:
H0: There is no significant difference between the intervention group and the the control group in the mean score of the "Wong-Baker FACES Pain Rating Scale", "Child Fear Scale", and "Child Anxiety Scale-State" during and after the Helfer Skin Tapping technique.
H1: During and after the Helfer Skin Tapping technique, the mean score of the "Wong-Baker FACES Pain Rating Scale", "Child Fear Scale", and "Child Anxiety Scale-State" is significantly lower in the intervention group compared to the control group.
Detailed description
In this study, there will be two groups as the intervention (who will receive an intramuscular injection with the Helfer Skin Tapping technique) and the control group (who will receive an intramuscular injection with Routine Technique). A power analysis was performed based on the number of children in both groups, based on another study using the scales to be used in the research. According to the calculations made in the G-Power 3.1 Demo package program, when the effect size was accepted as 0.8, it was seen that at least 32 cases in each group would be sufficient for 80% power. Children who meet the research criteria will be randomly assigned to the intervention and control groups via http://www.randomize.org/ by assigning a number to the order of arrival at the hospital. The intramuscular injection will be applied to both the intervention and control groups. The children in the intervention group will receive an intramuscular injection with the Helfer Skin Tapping technique and the control group will receive an intramuscular injection with Routine Technique in the pediatric emergency service. A researcher and a nurse were employed for the intramuscular injection both for the intervention and control groups. A pediatric nurse performed the intramuscular injection for all children and the other researcher helped the children to assess their pain, fear, and anxiety level. Pain, fear, and anxiety in children were evaluated by the children and their parents before, during, 5 minute after the procedure. The intramuscular injection will be performed by the same nurse both in the intervention and control groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Helfer Skin Tap TechniqueAll registered participants in the intervention group, will receive the intramuscular injection with Helfer Skin Tap Technique. |
| No intervention | No intervention | –All registered participants in the intervention group, will receive the intramuscular injection with Routine Technique. Routine Technique involved inserting the injection intra muscularly at 90 degree angle into Dorso gluteal muscles without tapping after cleaning with alcohol swab. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The child is between the ages of 4-10
- The child's application to the Pediatric Emergency Unit
- Parent and child agreeing to participate in the project
- Absence of speech and visual impairment of the child and his parents
Key exclusion criteria (4 listed)
- The child is not between the ages of 4-10
- The child's application to another department except for the Pediatric Emergency Unit
- Parent and child not agreeing to participate in the project
- Having speech and visual impairment of the child and his parents
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 |
|---|---|---|
| Helfer Skin Tap TechniqueHelfer Skin Tap Technique is a technique in which the researcher taps the Dorso gluteal muscle by counting 1-15 with the palmar aspect of fingers (non-dominant hand) in rhythmic manner before inserting the injection intra muscularly at 90 degree and remove the needle quickly again by tapping and counting 1-3. | Other | Experimental |
Primary outcome
Difference of the mean score of the "Wong Baker FACES Pain Rating Scale" between intervention and control groups
Time frame: 12 months
"Wong Baker FACES Pain Rating Scale" will be completed intramuscular injection with Helfer Skin Tap Technique that gathers quantitative data that will pain about intramuscular injection in children. A minimum of 0 points and a maximum of 10 points can be obtained from the scale. The higher scores mean the higher pain. This scale will also be completed at during and 5. minutes after the intervention. The quantitative data will be used to measure a change in the children's pain level before, and after the proposed intervention. The scale will be made with Routine Technique in the control group. At the end of the study, the change of the mean score of "Wong-Baker FACES Pain Rating Scale" between intervention and control groups will be examined. Data will be analyzed using Statistical Package for the Social Sciences package program.
Difference between the mean score of the "Child Fear Scale" between intervention and control groups
Time frame: 12 months
"The Child Fear Scale" will be completed intramuscular injection with Helfer Skin Tap Technique that gathers quantitative data that will fear about the intramuscular injection in children. A minimum of 0 points and a maximum of 20 points can be obtained from the scale. The higher scores mean the higher fear. This scale will also be completed at during and 5 minutes after the intervention. The quantitative data will be used to measure a change in the children's fear level before, and after the proposed intervention. The scale will be made with Routine Technique in the control group. At the end of the study, the change of the mean score of "The Child Fear Scale" between intervention and control groups will be examined. Data will be analyzed using Statistical Package for the Social Sciences package program.
Difference between the mean score of the "Child Anxiety Meter-State" between intervention and control groups
Time frame: 12 months
"The Child Anxiety Meter-State" will be completed intramuscular injection with Helfer Skin Tap Technique that gathers quantitative data that will anxiety about the intramuscular injection in children. A minimum of 0 points and a maximum of 10 points can be obtained from the scale. The higher scores mean the higher anxiety. This scale will also be completed at during and 5 minutes after the intervention. The quantitative data will be used to measure a change in the children's anxiety level before and after the proposed intervention. The scale will be made with Routine Technique in the control group. At the end of the study, the change of the mean score of "The Child Anxiety Meter-State" between intervention and control groups will be examined. The Child Anxiety Meter-State total score mean of the children in the intervention group will be lower after the intervention compared to the control group. Data will be analyzed using Statistical Package for the Social Sciences package program.
3 secondary outcomes
Change of the mean scores obtained by the children in the intervention group from the "Wong Baker FACES Pain Rating Scale" before and after the intervention.
Time frame: 12 months
Change of the mean scores obtained by the children in the intervention group from the "Child Fear Scale" before and after the intervention.
Time frame: 12 months
Change of the mean scores obtained by the children in the intervention group from the " Child Anxiety Meter-State " before and after the intervention.
Time frame: 12 months
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 11 May 2023.
- Individual participant dataSharing planned: Yes
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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 Helfer Skin Tap Technique in people with Pain, Acute and Fear Anxiety, run by Aylin Kurt 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 4 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 11 May 2023. 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?
Difference of the mean score of the "Wong Baker FACES Pain Rating Scale" between intervention and control groups (time frame: 12 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 11 May 2023.