Child, OnlyNCT06312228
The Effect of the Helper Skin Tap Technique and Buzzy® During Vaccination
A study testing Helfer Skin Tap and Buzzy in people with Child, Only, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial summary
Aim: This randomised controlled experimental study was conducted to determine the effect of Helfer Skin Tap Technique and Buzzy® application on the pain level during measles-mumps-rubella-mumps (MMR) vaccine injection in 4-year-old children.Method: The study was a randomised controlled experimental study. Read more about this study
- Who is it for?
- Ages 4 to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Child, Only
- What is being tested?
- Helfer Skin Tap and Buzzy
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 2 Oct 2023
- 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 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The child being at least 4 years old,
- The administration of the DTP vaccine,
- Being at an appropriate weight for their age,
- The child not having received any analgesic medication during the day,
- The willingness of the parent to participate in the research
Who cannot join
- Having a neurological illness,
- Having a chronic illness,
- Having an allergy (egg allergy),
- Having a body temperature above 37.5 degrees Celsius
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Helper Skin Tap Technique and Buzzy® Application on the Level of Pain and Anxiety Experienced by Children During Vaccination
Aim: This randomised controlled experimental study was conducted to determine the effect of Helfer Skin Tap Technique and Buzzy® application on the pain level during measles-mumps-rubella-mumps (MMR) vaccine injection in 4-year-old children.Method: The study was a randomised controlled experimental study. The sample of the study consisted of 96 children (buzzy: 32, helfer skin tap: 32, control: 32) who underwent MMR vaccination at Bakırköy Family Health Centre No. 9 between May 2023 and October 2023. Data Collection Form, Wong-Baker pain scale, Fear scale and Buzzy® device were used as data collection tools. Buzzy® and Helfer skin tap technique were applied to the children in the intervention group before and after the vaccine injection, while routine vaccine injection was applied to the children in the control group. Children's pain and fear responses were evaluated by the nurse and parents before and after vaccine injection, and physiological parameters were evaluated by the nurse before and after vaccine injection.
Read the detailed description
This randomised controlled experimental study was conducted to determine the effect of Helfer Skin Tap Technique and Buzzy® application on the pain level during measles-mumps-rubella-mumps (MMR) vaccine injection in 4-year-old children.
Materials and Methods Setting The sample of the study consisted of 96 children (buzzy: 32, helfer skin tap: 32, control: 32) who underwent MMR vaccination at Bakırköy Family Health Centre No. 9 between May 2023 and October 2023.
Sample The population of the study, which was planned as a randomised controlled experimental study, consisted of 4-year-old children who applied to Bakırköy Family Health Centre (FHC) No. 9 for MMR vaccination. According to the power analysis for the sample size in line with the literature (Mahato and Thakur 2019; Şıktaş and Uysal 2023), the power of the sample was calculated with the G*Power 3.1 programme. With a Type I error of 0.05 and a test power of 0.80 (α= 0.05, 1-β= 0.80), the minimum sample size (30 children in each group) was calculated as 90 children. Considering the losses that may occur from the sample for any reason during the study period, the study was completed with 96 children, including 32 children in the study and control groups.
Data Collection In the study, children who came to the Family Health Centre for MMR vaccination were first evaluated in terms of sampling criteria, and infants who did not meet the criteria were excluded from the study. The nurses who collected and administered the data are different. According to the childhood vaccination calendar of the Ministry of Health, MMR, quadrivalent mixed vaccine (DaBT-IPA (diphtheria, acellular pertussis, tetanus, inactive polio) are administered at the age of 4 years. The infants included in the study were first given MMR vaccine in the left arm and the other vaccine was given in the leg 10 minutes after the end of the administration.
Application MMR vaccine was administered according to the vaccine administration technique in the Ministry of Health's Expanded Immunisation Programme (2009) Circular. Vaccines are stored in the refrigerator under cold chain conditions between +2 0C - +8 0C. Before vaccine injection, it was ensured that the vaccination room was well lit and warm, and children were in a comfortable environment. The children in the Helfer Skin Tap Technique, buzzy and control group, who met the sampling criteria, were first examined by the family physician, and the parents of the children who did not have any objection to vaccination were informed about the research and their verbal and written consent was obtained and then the data collection form was filled out. Before the vaccine injection, body weight, height and physiological parameters (pulse, blood pressure, SpO2, body temperature) were measured and behavioural pain responses were evaluated by the child, nurse and parent using the Wong-Baker pain scale and fear scale. The child was first seated on the parent's lap (on the knee) and the holding position was adjusted. The child's legs were placed between the parent's legs and the arms were wrapped around the parent to hold the child. After the vaccine injection, pain and fear responses were evaluated by the nurse and parent using the Wong-Baker pain scale and fear scale. In addition, physiological parameters of the children were also measured and recorded.
STATISTICAL ANALYSIS Statistical analyses were performed using R vers. 2.15.3 program Minimum, maximum, mean, standard deviation, median, first quartile, third quartile, frequency, and percentage were used to report the study data. The Shapiro-Wilk test and graphical analysis were used to evaluate the compliance of quantitative data with normal distribution. A dependent groups t-test was used to compare the values before and after the intervention. An independent groups t-test was used to evaluate normally distributed variables between two groups. One-way analysis of variance was used in the evaluations of variables with normal distribution between more than two groups. The Mann-Whitney U test evaluated variables that did not show normal distribution between the two groups. The Kruskal-Wallis test was used in the evaluations of variables that did not show normal distribution between more than two groups. Pearson correlation analysis was used to determine the relationship between quantitative variables. The Pearson chi-square test, Fisher-Freeman-Halton exact test, and Fisher's exact test were used to compare qualitative variables. Statistical significance was accepted as p<0.05.
- Conditions
- Child, Only
- Being tested
- Helfer Skin Tap, Buzzy
- Keywords
- pain, fear, Buzzy, Helfer skin tap teknik
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helfer Skin TapOther
Slow tapping was performed with rhythmic tapping movements on the left deltoid muscle where the vaccine will be administered to the children. When the needle was to be inserted into the deltoid muscle, the tapping was slightly increased and the needle entry was made with the same movement. After the vaccine injection was given, the needle was rapidly withdrawn from the muscle by increasing the tapping movements while the needle was withdrawn.
BuzzyOther
The ice pack previously removed from the deep freezer was kept at room temperature for 10 minutes and the hole in the ice pack wing was placed on the hook behind the Buzzy®. The Buzzy® was placed on the left arm deltoid muscle and activated and kept for 30 seconds. After 30 seconds, Buzzy® was pulled up 1 centimetre (cm) and the MMR vaccine injection was administered to the area corresponding to the left deltoid muscle. After the vaccine injection, Buzzy® was pulled to the injection site and kept for another 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Helper Skin Tap Technique Group | Experimental | Before the vaccine injection, body weight, height and physiological parameters (pulse, blood pressure, SpO2, body temperature) were measured and behavioural pain responses were evaluated by the child, nurse and parent using the Wong-Baker pain scale and fear scale. Slow tapping was performed with rhythmic tapping movements on the left deltoid muscle where the vaccine will be administered to the children. When the needle was to be inserted into the deltoid muscle, the tapping was slightly increased and the needle entry was made with the same movement. After the vaccine injection was given, the needle was rapidly withdrawn from the muscle by increasing the tapping movements while the needle was withdrawn. Receives: Other: Helfer Skin Tap |
| Buzzy Group | Experimental | Before the vaccine injection, body weight, height and physiological parameters (pulse, blood pressure, SpO2, body temperature) were measured and behavioural pain responses were evaluated by the child, nurse and parent using the Wong-Baker pain scale and fear scale. The ice pack previously removed from the deep freezer was kept at room temperature for 10 minutes and the hole in the ice pack wing was placed on the hook behind the Buzzy®. The Buzzy® was placed on the left arm deltoid muscle and activated and kept for 30 seconds. After 30 seconds, Buzzy® was pulled up 1 centimetre (cm) and the MMR vaccine injection was administered to the area corresponding to the left deltoid muscle. After the vaccine injection, Buzzy® was pulled to the injection site and kept for another 30 seconds. Receives: Other: Buzzy |
| Control Group | No intervention | Before the vaccine injection, body weight, height and physiological parameters (pulse, blood pressure, SpO2, body temperature) were measured and behavioural pain responses were evaluated by the child, nurse and parent using the Wong-Baker pain scale and fear scale. MMR vaccine injection was routinely administered in the area corresponding to the left deltoid muscle without any intervention or application to the injection site. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Information Form
The information form has been prepared by reviewing the literature on the subject (Canbulat and Bal 2015; Canbulat et al 2014) and includes the child's age, gender, height, weight, presence of other children in the family, physiological parameters before and after vaccination injection, Wong-Baker pain score, and Fear score evaluated by the nurse, parent, and child before and after the vaccination injection. There are a total of 5 questions in the data collection form.
Measured: 1 day
Wong-Baker Scale (Pain Facial Expression Scale)
The Wong-Baker scale consists of faces representing increasing levels of pain from zero to five, moving from left to right. The face on the far left has a smiling expression, indicating a pain-free condition, while the face on the far right has a crying expression, representing the most severe pain. Each facial expression is accompanied by a brief description explaining the pain intensity: 0 - no pain, 1 - mild pain, 2 - a bit more pain, 3 - even more pain, 4 - quite a lot of pain, 5 - the most severe pain.
Measured: 1 day
Child Fear Scale
The Child Fear Scale is used to assess the anxiety levels of children with five face shapes scored between 0-4: 0 = no anxiety, and 4 = severe anxiety. The scale can be evaluated by both the child and the researcher before, during, and after the intervention.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 May 2023
- Primary completion2 Oct 2023
- Study completion2 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Child, OnlyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Sonmez Duzkaya, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312228
- Sponsor's protocol ID
- 2023/05
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 33939726Therese, A. M., & Devi, S. (2014). Effectiveness of Helfer skin tap technique and routine technique on pain reduction among patients receiving intramuscular injection at Government General Hospital, Puducherry. Int J Sci Res, 3(10).
Jose, R. M., Sulochana, B., & Shetty, S. (2012). Effectiveness of Skin Tap Technique in Reducing Pain Response. International Journal of Nursing Education, 4(1).
Mahato, E. (2019). Effectiveness of Helfer's Skin Tap Technique Versus Routine Technique on Pain Reduction among Patient's Receiving Intramuscular Injections. International Journal of Nursing Education, 11(1),41-44.
Taddio A, McMurtry CM, Shah V, Riddell RP, Chambers CT, Noel M, MacDonald NE, Rogers J, Bucci LM, Mousmanis P, Lang E, Halperin SA, Bowles S, Halpert C, Ipp M, Asmundson GJG, Rieder MJ, Robson K, Uleryk E, Antony MM, Dubey V, Hanrahan A, Lockett D, Scott J, Bleeker EV; HELPinKids&Adults. Reducing pain during vaccine injections: clinical practice guideline. CMAJ. 2015 Sep 22;187(13):975-982. doi: 10.1503/cmaj.150391. Epub 2015 Aug 24. No abstract available.
PubMed 26303247Shah V, Taddio A, McMurtry CM, Halperin SA, Noel M, Pillai Riddell R, Chambers CT; HELPinKIDS Team. Pharmacological and Combined Interventions to Reduce Vaccine Injection Pain in Children and Adults: Systematic Review and Meta-Analysis. Clin J Pain. 2015 Oct;31(10 Suppl):S38-63. doi: 10.1097/AJP.0000000000000281.
PubMed 26201016Noel M, Chambers CT, McGrath PJ, Klein RM, Stewart SH. The influence of children's pain memories on subsequent pain experience. Pain. 2012 Aug;153(8):1563-1572. doi: 10.1016/j.pain.2012.02.020. Epub 2012 May 3.
PubMed 22560288Koc T, Gozen D. The Effect of Foot Reflexology on Acute Pain in Infants: A Randomized Controlled Trial. Worldviews Evid Based Nurs. 2015 Oct;12(5):289-96. doi: 10.1111/wvn.12099. Epub 2015 Jul 28.
PubMed 26220257
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Helper Skin Tap Technique and Buzzy® Application on the Level of Pain and Anxiety Experienced by Children During Vaccination
- ClinicalTrials.gov ID
- NCT06312228
- Acronym / sponsor ID
- 2023/05
- Conditions
- Child, Only
- Keywords
- pain, fear, Buzzy, Helfer skin tap teknik
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 15 Mar 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.
Aim: This randomised controlled experimental study was conducted to determine the effect of Helfer Skin Tap Technique and Buzzy® application on the pain level during measles-mumps-rubella-mumps (MMR) vaccine injection in 4-year-old children.Method: The study was a randomised controlled experimental study. The sample of the study consisted of 96 children (buzzy: 32, helfer skin tap: 32, control: 32) who underwent MMR vaccination at Bakırköy Family Health Centre No. 9 between May 2023 and October 2023. Data Collection Form, Wong-Baker pain scale, Fear scale and Buzzy® device were used as data collection tools. Buzzy® and Helfer skin tap technique were applied to the children in the intervention group before and after the vaccine injection, while routine vaccine injection was applied to the children in the control group. Children's pain and fear responses were evaluated by the nurse and parents before and after vaccine injection, and physiological parameters were evaluated by the nurse before and after vaccine injection.
Detailed description
This randomised controlled experimental study was conducted to determine the effect of Helfer Skin Tap Technique and Buzzy® application on the pain level during measles-mumps-rubella-mumps (MMR) vaccine injection in 4-year-old children.
Materials and Methods Setting The sample of the study consisted of 96 children (buzzy: 32, helfer skin tap: 32, control: 32) who underwent MMR vaccination at Bakırköy Family Health Centre No. 9 between May 2023 and October 2023.
Sample The population of the study, which was planned as a randomised controlled experimental study, consisted of 4-year-old children who applied to Bakırköy Family Health Centre (FHC) No. 9 for MMR vaccination. According to the power analysis for the sample size in line with the literature (Mahato and Thakur 2019; Şıktaş and Uysal 2023), the power of the sample was calculated with the G*Power 3.1 programme. With a Type I error of 0.05 and a test power of 0.80 (α= 0.05, 1-β= 0.80), the minimum sample size (30 children in each group) was calculated as 90 children. Considering the losses that may occur from the sample for any reason during the study period, the study was completed with 96 children, including 32 children in the study and control groups.
Data Collection In the study, children who came to the Family Health Centre for MMR vaccination were first evaluated in terms of sampling criteria, and infants who did not meet the criteria were excluded from the study. The nurses who collected and administered the data are different. According to the childhood vaccination calendar of the Ministry of Health, MMR, quadrivalent mixed vaccine (DaBT-IPA (diphtheria, acellular pertussis, tetanus, inactive polio) are administered at the age of 4 years. The infants included in the study were first given MMR vaccine in the left arm and the other vaccine was given in the leg 10 minutes after the end of the administration.
Application MMR vaccine was administered according to the vaccine administration technique in the Ministry of Health's Expanded Immunisation Programme (2009) Circular. Vaccines are stored in the refrigerator under cold chain conditions between +2 0C - +8 0C. Before vaccine injection, it was ensured that the vaccination room was well lit and warm, and children were in a comfortable environment. The children in the Helfer Skin Tap Technique, buzzy and control group, who met the sampling criteria, were first examined by the family physician, and the parents of the children who did not have any objection to vaccination were informed about the research and their verbal and written consent was obtained and then the data collection form was filled out. Before the vaccine injection, body weight, height and physiological parameters (pulse, blood pressure, SpO2, body temperature) were measured and behavioural pain responses were evaluated by the child, nurse and parent using the Wong-Baker pain scale and fear scale. The child was first seated on the parent's lap (on the knee) and the holding position was adjusted. The child's legs were placed between the parent's legs and the arms were wrapped around the parent to hold the child. After the vaccine injection, pain and fear responses were evaluated by the nurse and parent using the Wong-Baker pain scale and fear scale. In addition, physiological parameters of the children were also measured and recorded.
STATISTICAL ANALYSIS Statistical analyses were performed using R vers. 2.15.3 program Minimum, maximum, mean, standard deviation, median, first quartile, third quartile, frequency, and percentage were used to report the study data. The Shapiro-Wilk test and graphical analysis were used to evaluate the compliance of quantitative data with normal distribution. A dependent groups t-test was used to compare the values before and after the intervention. An independent groups t-test was used to evaluate normally distributed variables between two groups. One-way analysis of variance was used in the evaluations of variables with normal distribution between more than two groups. The Mann-Whitney U test evaluated variables that did not show normal distribution between the two groups. The Kruskal-Wallis test was used in the evaluations of variables that did not show normal distribution between more than two groups. Pearson correlation analysis was used to determine the relationship between quantitative variables. The Pearson chi-square test, Fisher-Freeman-Halton exact test, and Fisher's exact test were used to compare qualitative variables. Statistical significance was accepted as p<0.05.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Helper Skin Tap Technique Group | Experimental | Other: Helfer Skin TapBefore the vaccine injection, body weight, height and physiological parameters (pulse, blood pressure, SpO2, body temperature) were measured and behavioural pain responses were evaluated by the child, nurse and parent using the Wong-Baker pain scale and fear scale. Slow tapping was performed with rhythmic tapping movements on the left deltoid muscle where the vaccine will be administered to the children. When the needle was to be inserted into the deltoid muscle, the tapping was slightly increased and the needle entry was made with the same movement. After the vaccine injection was given, the needle was rapidly withdrawn from the muscle by increasing the tapping movements while the needle was withdrawn. |
| Buzzy Group | Experimental | Other: BuzzyBefore the vaccine injection, body weight, height and physiological parameters (pulse, blood pressure, SpO2, body temperature) were measured and behavioural pain responses were evaluated by the child, nurse and parent using the Wong-Baker pain scale and fear scale. The ice pack previously removed from the deep freezer was kept at room temperature for 10 minutes and the hole in the ice pack wing was placed on the hook behind the Buzzy®. The Buzzy® was placed on the left arm deltoid muscle and activated and kept for 30 seconds. After 30 seconds, Buzzy® was pulled up 1 centimetre (cm) and the MMR vaccine injection was administered to the area corresponding to the left deltoid muscle. After the vaccine injection, Buzzy® was pulled to the injection site and kept for another 30 seconds. |
| Control Group | No intervention | –Before the vaccine injection, body weight, height and physiological parameters (pulse, blood pressure, SpO2, body temperature) were measured and behavioural pain responses were evaluated by the child, nurse and parent using the Wong-Baker pain scale and fear scale. MMR vaccine injection was routinely administered in the area corresponding to the left deltoid muscle without any intervention or application to the injection site. |
Who may qualify
- Ages
- 4 to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- The child being at least 4 years old,
- The administration of the DTP vaccine,
Key exclusion criteria (4 listed)
- Having a neurological illness,
- Having a chronic illness,
- Having an allergy (egg allergy),
- Having a body temperature above 37.5 degrees Celsius
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 TapSlow tapping was performed with rhythmic tapping movements on the left deltoid muscle where the vaccine will be administered to the children. When the needle was to be inserted into the deltoid muscle, the tapping was slightly increased and the needle entry was made with the same movement. After the vaccine injection was given, the needle was rapidly withdrawn from the muscle by increasing the tapping movements while the needle was withdrawn. | Other | Helper Skin Tap Technique Group |
| BuzzyThe ice pack previously removed from the deep freezer was kept at room temperature for 10 minutes and the hole in the ice pack wing was placed on the hook behind the Buzzy®. The Buzzy® was placed on the left arm deltoid muscle and activated and kept for 30 seconds. After 30 seconds, Buzzy® was pulled up 1 centimetre (cm) and the MMR vaccine injection was administered to the area corresponding to the left deltoid muscle. After the vaccine injection, Buzzy® was pulled to the injection site and kept for another 30 seconds. | Other | Buzzy Group |
Primary outcome
Child Information Form
Time frame: 1 day
The information form has been prepared by reviewing the literature on the subject (Canbulat and Bal 2015; Canbulat et al 2014) and includes the child's age, gender, height, weight, presence of other children in the family, physiological parameters before and after vaccination injection, Wong-Baker pain score, and Fear score evaluated by the nurse, parent, and child before and after the vaccination injection. There are a total of 5 questions in the data collection form.
Wong-Baker Scale (Pain Facial Expression Scale)
Time frame: 1 day
The Wong-Baker scale consists of faces representing increasing levels of pain from zero to five, moving from left to right. The face on the far left has a smiling expression, indicating a pain-free condition, while the face on the far right has a crying expression, representing the most severe pain. Each facial expression is accompanied by a brief description explaining the pain intensity: 0 - no pain, 1 - mild pain, 2 - a bit more pain, 3 - even more pain, 4 - quite a lot of pain, 5 - the most severe pain.
Child Fear Scale
Time frame: 1 day
The Child Fear Scale is used to assess the anxiety levels of children with five face shapes scored between 0-4: 0 = no anxiety, and 4 = severe anxiety. The scale can be evaluated by both the child and the researcher before, during, and after the intervention.
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 15 Mar 2024.
- Background: PubMed 33939726Ayinde 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.
- BackgroundTherese, A. M., & Devi, S. (2014). Effectiveness of Helfer skin tap technique and routine technique on pain reduction among patients receiving intramuscular injection at Government General Hospital, Puducherry. Int J Sci Res, 3(10).
- BackgroundJose, R. M., Sulochana, B., & Shetty, S. (2012). Effectiveness of Skin Tap Technique in Reducing Pain Response. International Journal of Nursing Education, 4(1).
- BackgroundMahato, E. (2019). Effectiveness of Helfer's Skin Tap Technique Versus Routine Technique on Pain Reduction among Patient's Receiving Intramuscular Injections. International Journal of Nursing Education, 11(1),41-44.
- Background: PubMed 26303247Taddio A, McMurtry CM, Shah V, Riddell RP, Chambers CT, Noel M, MacDonald NE, Rogers J, Bucci LM, Mousmanis P, Lang E, Halperin SA, Bowles S, Halpert C, Ipp M, Asmundson GJG, Rieder MJ, Robson K, Uleryk E, Antony MM, Dubey V, Hanrahan A, Lockett D, Scott J, Bleeker EV; HELPinKids&Adults. Reducing pain during vaccine injections: clinical practice guideline. CMAJ. 2015 Sep 22;187(13):975-982. doi: 10.1503/cmaj.150391. Epub 2015 Aug 24. No abstract available.
- Background: PubMed 26201016Shah V, Taddio A, McMurtry CM, Halperin SA, Noel M, Pillai Riddell R, Chambers CT; HELPinKIDS Team. Pharmacological and Combined Interventions to Reduce Vaccine Injection Pain in Children and Adults: Systematic Review and Meta-Analysis. Clin J Pain. 2015 Oct;31(10 Suppl):S38-63. doi: 10.1097/AJP.0000000000000281.
- Background: PubMed 22560288Noel M, Chambers CT, McGrath PJ, Klein RM, Stewart SH. The influence of children's pain memories on subsequent pain experience. Pain. 2012 Aug;153(8):1563-1572. doi: 10.1016/j.pain.2012.02.020. Epub 2012 May 3.
- Background: PubMed 26220257Koc T, Gozen D. The Effect of Foot Reflexology on Acute Pain in Infants: A Randomized Controlled Trial. Worldviews Evid Based Nurs. 2015 Oct;12(5):289-96. doi: 10.1111/wvn.12099. Epub 2015 Jul 28.
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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 and Buzzy in people with Child, Only, run by Tarsus 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 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 15 Mar 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?
Child Information Form (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 NCT06312228, which also lists 8 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 15 Mar 2024.