PainNCT06370117
The Effects of Three Different Nonpharmacological Methods Used During Vascular Access in Children on Pain and Anxiety
A study testing Buzzy, Music video listening and Buzzy+ Music video listening in people with Pain and Anxiety, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
The research was conducted to evaluate the effects of three different non-pharmacological methods (playing a music video, buzzy application, listening to a music video + buzzy application) on the pain and anxiety levels of children in the 4-12 age group during vascular access. H0.1. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Anxiety, Nurse's Role
- What is being tested?
- Buzzy, Music video listening and Buzzy+ Music video listening
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2023to 30 Dec 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- being between the ages of 4-12
- being willing to participate in the study,
- being accompanied by their parents (mother or father).
Who cannot join
- Failure to establish vascular access on the first try
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bircan Kahraman Berberoğlu
Aydin, AYDIN-efeler, 0900
About this study
The research was conducted to evaluate the effects of three different non-pharmacological methods (playing a music video, buzzy application, listening to a music video + buzzy application) on the pain and anxiety levels of children in the 4-12 age group during vascular access.
H0.1. Playing music (music video) during the vascular access procedure has no effect on children's pain and anxiety levels.
H0.2. Applying buzzy during the vascular access procedure has no effect on children's pain and anxiety levels.
H0.3. Listening to a music video + applying buzzy during the vascular access procedure has no effect on children's pain and anxiety levels.
Read the detailed description
Design: It is a randomized controlled experimental study. Methods: This study was conducted between February and December 2023 with 126 children between the ages of 4 and 12 who were hospitalized in the pediatric ward of a public hospital in a province in eastern Turkey and had vascular access. The sample consisted of four groups: a music video listening group (n=31), a buzzy group (n=32), a music video listening + buzzy group (n=31), and a control group (n= 32). Children were selected into groups by simple randomization method. Data were collected 60 seconds before starting the vascular access procedure and as soon as the procedure was completed. Introductory Information Form, Child Fear and Anxiety Scale and Wong-Baker Facial Expression Rating Scale were used to collect data.
The data was analyzed on SPSS (Version 25, Chicago, IL, USA). The Gaussian curve and Shapiro-Wilk test were used to assess whether or not the data were normally distributed. Descriptive statistical tests (arithmetic mean, standard deviation, number, and percentage) were also conducted. The conformity of the measurement values to normal distribution was tested with "Shapirow-wilk" analysis. Pearson chi-square test was applied to the dependency relationship of frequency measurement values. One-factor ANOVA test was used to compare whether there was a statistically significant difference between the means of independent groups. Kruskal Wallis H-Test was used to compare groups that did not show normal distribution. Mann Whitney U test was used in further analysis to determine the difference between two independent groups. Wilcoxon test was used to test the significance of the difference between the scores of two related measurements. P values <0.05 were considered statistically significant.
- Conditions
- Pain, Anxiety, Nurse's Role
- Being tested
- Buzzy, Music video listening, Buzzy+ Music video listening
- Keywords
- Pain, Anxiety, Nurse's Role, Child
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuzzyBehavioural
Before the procedure; 60 seconds before starting the vascular access process, the Buzzy® tool was placed in the procedure area and cold and vibration application was started. The tourniquet was tied 10-12 cm above the vein to be treated. The Buzzy® tool was fixed to the middle part of the procedure area and the tourniquet, approximately 2 cm above the IV catheter entry site.
Music video listeningBehavioural
Before the procedure; A music video was played 60 seconds before starting the intravenous access procedure.
Buzzy+ Music video listeningBehavioural
60 seconds before starting the vascular access process, a music video was played and cold and vibration application was started with the Buzzy® tool. 60 seconds before the procedure began, the Buzzy® tool was placed on the procedure area and cold and vibration application was initiated. The tourniquet was tied 10-12 cm above the vein to be treated. The Buzzy® tool was fixed midway between the procedure area and the tourniquet, approximately 2 cm above the IV catheter entry site.
| Study group | Role | What they receive |
|---|---|---|
| control group (n= 34) | No intervention | Control group (n=34) Routine vascular access was performed on the children in the control group. Apart from this, no other application was made. Before the procedure; Introductory Information Form, Wong-Baker Facial Expression Rating Scale and Child Fear and Anxiety Scale were filled out by the researcher. Process order; Routine vascular access was performed. A stopwatch was used for the procedure time and the procedure time was recorded. The Child Fear and Anxiety Scale and the Wong-Baker Facial Expression Rating Scale were completed again. |
| Buzzy Group (n= 34) | Experimental | Before the procedure; 60 seconds before starting the vascular access process, the Buzzy® tool was placed in the procedure area and cold and vibration application was started. The tourniquet was tied 10-12 cm above the vein to be treated. The Buzzy® tool was fixed to the middle part of the procedure area and the tourniquet, approximately 2 cm above the IV catheter entry site. As soon as the vascular access was established, the Introductory Information Form, Wong-Baker Facial Expression Rating Scale, and Child Fear and Anxiety Scale were filled out by the researcher. Process order; Application with the Buzzy® tool continued throughout the process. A stopwatch was used to time the procedure and the Buzzy® tool was removed when the procedure was completed. The Child Fear and Anxiety Scale and the Wong-Baker Facial Expression Rating Scale were completed again. Receives: Behavioral: Buzzy |
| Music video listening group (n= 34) | Experimental | The children in study group II were listened to music starting from 60 seconds before the vascular access procedure until the procedure ended.
Before the procedure; A music video was played 60 seconds before starting the intravenous access procedure. The Introductory Information Form, Wong-Baker Facial Expression Rating Scale, and Child Fear and Anxiety Scale were filled in by the researcher.
Process order; Music video playback continued. A stopwatch was used for the procedure time. As soon as the vascular access was established, the Child Fear and Anxiety Scale and the Wong-Baker Facial Expression Rating Scale were filled out again. Receives: Behavioral: Music video listening |
| Buzzy+ Music video listening Group (n= 34) | Experimental | Before the procedure; 60 seconds before starting the vascular access process, a music video was played and cold and vibration application was started with the Buzzy® tool.60 seconds before the procedure began, the Buzzy® tool was placed on the procedure area and cold and vibration application was initiated.Moreover,a music video was played. The tourniquet was tied 10-12 cm above the vein to be treated.The Buzzy® tool was fixed to the middle part of the procedure area and the tourniquet, approximately 2 cm above the IV catheter entry site. Introductory Information Form, Wong-Baker Facial Expression Rating Scale and Child Fear and Anxiety Scale were filled in by the researcher.Process order; application continued. A stopwatch was used for the procedure time.When vascular access was established, the Child Fear and Anxiety and Wong-Baker Facial Expression Rating Scale were filled out again.Once the process was finished, the buzzy was removed and the music video was closed. Receives: Behavioral: Buzzy+ Music video listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wong-Baker Facial Expression Rating Scale
Wong-Baker Facial Expression Rating Scale (WB-FRS): It was developed by Wong and Baker in 1981. This scale is used to diagnose pain in children aged 3-18. This scale has six faces representing pain intensity, increasing from zero to five from left to right (0 points = very happy/no pain, 5 points = the most severe pain). The face on the far left has a smiling expression, indicating a pain-free state, while the face on the far right has a crying expression, corresponding to the most severe pain. The child is told to choose the face that best expresses his/her feelings.
Measured: From date of randomization (February 1, 2023) until the date of (December 30, 2023)/ for 9 months
Secondary outcomes (1)
Children's Fear and Anxiety Scale
Children's Fear and Anxiety Scale (CCAS): McMurtry et al. It was developed by in 2011. In this scale, the child is shown a picture containing five facial expressions rated between 0 and 4 points. While 0 indicates no fear and anxiety; 4 represents the highest fear and anxiety [0: neutral expression (no anxiety), 1: very little fear (very little anxiety), 2: some fear (some anxiety), 3: more fear (more anxiety), 4: possible shows the highest fear (severe anxiety).
Measured: From date of randomization (February 1, 2023) until the date of (December 30, 2023)/ for 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 Feb 2023
- Primary completion30 Oct 2023
- Study completion30 Dec 2023
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 Aydin Adnan Menderes 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a randomized controlled experimental study.
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bircan Kahraman Berberoglu, Aydin Adnan Menderes University
- Investigators
- BIRCAN KAHRAMAN BERBEROĞLU, Study chair, Aydın Adnan Menderes Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06370117
- Sponsor's protocol ID
- Aydın Adnan Menderes
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Three Different Nonpharmacological Methods Used During Vascular Access in Children on Pain and Anxiety
- ClinicalTrials.gov ID
- NCT06370117
- Acronym / sponsor ID
- Aydın Adnan Menderes
- Conditions
- Pain, Anxiety, Nurse's Role
- Keywords
- Pain, Anxiety, Nurse's Role, Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 17 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.
The research was conducted to evaluate the effects of three different non-pharmacological methods (playing a music video, buzzy application, listening to a music video + buzzy application) on the pain and anxiety levels of children in the 4-12 age group during vascular access.
H0.1. Playing music (music video) during the vascular access procedure has no effect on children's pain and anxiety levels.
H0.2. Applying buzzy during the vascular access procedure has no effect on children's pain and anxiety levels.
H0.3. Listening to a music video + applying buzzy during the vascular access procedure has no effect on children's pain and anxiety levels.
Detailed description
Design: It is a randomized controlled experimental study. Methods: This study was conducted between February and December 2023 with 126 children between the ages of 4 and 12 who were hospitalized in the pediatric ward of a public hospital in a province in eastern Turkey and had vascular access. The sample consisted of four groups: a music video listening group (n=31), a buzzy group (n=32), a music video listening + buzzy group (n=31), and a control group (n= 32). Children were selected into groups by simple randomization method. Data were collected 60 seconds before starting the vascular access procedure and as soon as the procedure was completed. Introductory Information Form, Child Fear and Anxiety Scale and Wong-Baker Facial Expression Rating Scale were used to collect data.
The data was analyzed on SPSS (Version 25, Chicago, IL, USA). The Gaussian curve and Shapiro-Wilk test were used to assess whether or not the data were normally distributed. Descriptive statistical tests (arithmetic mean, standard deviation, number, and percentage) were also conducted. The conformity of the measurement values to normal distribution was tested with "Shapirow-wilk" analysis. Pearson chi-square test was applied to the dependency relationship of frequency measurement values. One-factor ANOVA test was used to compare whether there was a statistically significant difference between the means of independent groups. Kruskal Wallis H-Test was used to compare groups that did not show normal distribution. Mann Whitney U test was used in further analysis to determine the difference between two independent groups. Wilcoxon test was used to test the significance of the difference between the scores of two related measurements. P values <0.05 were considered statistically significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- It is a randomized controlled experimental study.
| Arm | Type | Receives |
|---|---|---|
| control group (n= 34) | No intervention | –Control group (n=34) Routine vascular access was performed on the children in the control group. Apart from this, no other application was made. Before the procedure; Introductory Information Form, Wong-Baker Facial Expression Rating Scale and Child Fear and Anxiety Scale were filled out by the researcher. Process order; Routine vascular access was performed. A stopwatch was used for the procedure time and the procedure time was recorded. The Child Fear and Anxiety Scale and the Wong-Baker Facial Expression Rating Scale were completed again. |
| Buzzy Group (n= 34) | Experimental | Behavioral: BuzzyBefore the procedure; 60 seconds before starting the vascular access process, the Buzzy® tool was placed in the procedure area and cold and vibration application was started. The tourniquet was tied 10-12 cm above the vein to be treated. The Buzzy® tool was fixed to the middle part of the procedure area and the tourniquet, approximately 2 cm above the IV catheter entry site. As soon as the vascular access was established, the Introductory Information Form, Wong-Baker Facial Expression Rating Scale, and Child Fear and Anxiety Scale were filled out by the researcher. Process order; Application with the Buzzy® tool continued throughout the process. A stopwatch was used to time the procedure and the Buzzy® tool was removed when the procedure was completed. The Child Fear and Anxiety Scale and the Wong-Baker Facial Expression Rating Scale were completed again. |
| Music video listening group (n= 34) | Experimental | Behavioral: Music video listeningThe children in study group II were listened to music starting from 60 seconds before the vascular access procedure until the procedure ended. Before the procedure; A music video was played 60 seconds before starting the intravenous access procedure. The Introductory Information Form, Wong-Baker Facial Expression Rating Scale, and Child Fear and Anxiety Scale were filled in by the researcher. Process order; Music video playback continued. A stopwatch was used for the procedure time. As soon as the vascular access was established, the Child Fear and Anxiety Scale and the Wong-Baker Facial Expression Rating Scale were filled out again. |
| Buzzy+ Music video listening Group (n= 34) | Experimental | Behavioral: Buzzy+ Music video listeningBefore the procedure; 60 seconds before starting the vascular access process, a music video was played and cold and vibration application was started with the Buzzy® tool.60 seconds before the procedure began, the Buzzy® tool was placed on the procedure area and cold and vibration application was initiated.Moreover,a music video was played. The tourniquet was tied 10-12 cm above the vein to be treated.The Buzzy® tool was fixed to the middle part of the procedure area and the tourniquet, approximately 2 cm above the IV catheter entry site. Introductory Information Form, Wong-Baker Facial Expression Rating Scale and Child Fear and Anxiety Scale were filled in by the researcher.Process order; application continued. A stopwatch was used for the procedure time.When vascular access was established, the Child Fear and Anxiety and Wong-Baker Facial Expression Rating Scale were filled out again.Once the process was finished, the buzzy was removed and the music video was closed. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- being between the ages of 4-12
- being willing to participate in the study,
- being accompanied by their parents (mother or father).
Key exclusion criteria (1 listed)
- Failure to establish vascular access on the first try
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 |
|---|---|---|
| BuzzyBefore the procedure; 60 seconds before starting the vascular access process, the Buzzy® tool was placed in the procedure area and cold and vibration application was started. The tourniquet was tied 10-12 cm above the vein to be treated. The Buzzy® tool was fixed to the middle part of the procedure area and the tourniquet, approximately 2 cm above the IV catheter entry site. | Behavioural | Buzzy Group (n= 34) |
| Music video listeningBefore the procedure; A music video was played 60 seconds before starting the intravenous access procedure. | Behavioural | Music video listening group (n= 34) |
| Buzzy+ Music video listening60 seconds before starting the vascular access process, a music video was played and cold and vibration application was started with the Buzzy® tool. 60 seconds before the procedure began, the Buzzy® tool was placed on the procedure area and cold and vibration application was initiated. The tourniquet was tied 10-12 cm above the vein to be treated. The Buzzy® tool was fixed midway between the procedure area and the tourniquet, approximately 2 cm above the IV catheter entry site. | Behavioural | Buzzy+ Music video listening Group (n= 34) |
Primary outcome
Wong-Baker Facial Expression Rating Scale
Time frame: From date of randomization (February 1, 2023) until the date of (December 30, 2023)/ for 9 months
Wong-Baker Facial Expression Rating Scale (WB-FRS): It was developed by Wong and Baker in 1981. This scale is used to diagnose pain in children aged 3-18. This scale has six faces representing pain intensity, increasing from zero to five from left to right (0 points = very happy/no pain, 5 points = the most severe pain). The face on the far left has a smiling expression, indicating a pain-free state, while the face on the far right has a crying expression, corresponding to the most severe pain. The child is told to choose the face that best expresses his/her feelings.
1 secondary outcome
Children's Fear and Anxiety Scale
Time frame: From date of randomization (February 1, 2023) until the date of (December 30, 2023)/ for 9 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 17 Apr 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.
BIRCAN KAHRAMAN BERBEROĞLU study chair
Aydın Adnan Menderes Univercity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buzzy, Music video listening and Buzzy+ Music video listening in people with Pain and Anxiety, run by Aydin Adnan Menderes 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 3 inclusion and 1 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 17 Apr 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?
Wong-Baker Facial Expression Rating Scale (time frame: From date of randomization (February 1, 2023) until the date of (December 30, 2023)/ for 9 months). 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 17 Apr 2024.