Acute PainNCT04113980
Effects of Distraction Methods on Pain Perceptions and Anxiety Levels in Children During the Blood Collection
A study testing music group, kaleidoscope group and video group in people with Acute Pain and Nursing Caries, run by Adiyaman University Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Aim:This study was conducted to investigate the effects of music, kaleidoscope and video watching methods on children's pain perception and anxiety level during the blood collection procedures. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Pain, Nursing Caries
- What is being tested?
- music group, kaleidoscope group and video group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2018to 1 Nov 2018
- 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 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- being healthy
- ability to express himself/herself verbally
- no analgesic taken in the last 6 hours
- having no visual or auditory problems
Who cannot join
- chronic disease
- mental disease
- neurological disease
Trial locations and contacts
1 site in 1 country.
About this study
Aim:This study was conducted to investigate the effects of music, kaleidoscope and video watching methods on children's pain perception and anxiety level during the blood collection procedures.
Methods: This randomized controlled experimental study was carried out with 134 children in the 5-10 age group in the pediatric blood collection unit of a Training and Research Hospital between August and November 2018. In the study, nonpharmacological methods were applied to the children in the experimental groups (Music Group (n=33), Kaleidoscope Group (n=36), Video Group (n=31). The routine blood collection procedure was used for the children in the control group (n=34). The data were collected using the "Introductory Information Form", "Children's Fear and Anxiety Scale (CFAS)", and the "Wong-Baker Faces Pain Rating Scale (WB-FPRS)".
- Conditions
- Acute Pain, Nursing Caries
- Being tested
- music group, kaleidoscope group, video group
- Keywords
- acute pain, anxiety, children, blood collection, nursing
- Medical subject headings
- Acute Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music groupOther
The children in the groups were distracted by music 2 minutes before venipuncture, until the process was over
kaleidoscope groupOther
The children in the groups were distracted by kaleidoscope 2 minutes before venipuncture, until the process was over
video groupOther
The children in the groups were distracted by watching video 2 minutes before venipuncture, until the process was over
| Study group | Role | What they receive |
|---|---|---|
| music group | Experimental | The children in the groups were distracted by listening music 2 minutes before venipuncture, until the process was over. Receives: Other: music group |
| kaleidescope group | Experimental | The children in the groups were distracted by kaleidoscope 2 minutes before the blood collection, until the process was over. Receives: Other: kaleidoscope group |
| video group | Experimental | The children in the groups were distracted by watching cartoon 2 minutes before the blood collection, until the process was over. Receives: Other: video group |
| control group | No intervention | No intervention was made to children in the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Children Fear Scale
The Children Fear Scale was used to evaluate the children's fear and anxiety. Children Fear Scale is a 0-4 scale, showing five faces that range from a neutral expression (0 = no anxiety) to a frightened face (4 = severe anxiety). Preprocedural and procedural pain, and anxiety were evaluated
Measured: 1 minute
Wong Baker Face Pain Scale
The Wong Baker Faces scale is a 0-10 scale. Six faces on the cards show a range of emotions from a smiling face (0 very happy/no pain) to a crying face (10 'hurts worst').
Measured: 1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start1 Aug 2018
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman University Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuba Koc Ozkan, Adiyaman University Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04113980
- Sponsor's protocol ID
- Adiyaman University/2018/2-23
- Status last verified
- Oct 2019
- First submitted
- 1 Oct 2019
- Last updated
- 15 Oct 2019
- Results posted
- 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 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Distraction Methods on Pain Perceptions and Anxiety Levels in Children During the Blood Collection
- ClinicalTrials.gov ID
- NCT04113980
- Acronym / sponsor ID
- Adiyaman University/2018/2-23
- Conditions
- Acute Pain, Nursing Caries
- Keywords
- acute pain, anxiety, children, blood collection, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Adiyaman University Research HospitalUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 3 Oct 2019 (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 study was conducted to investigate the effects of music, kaleidoscope and video watching methods on children's pain perception and anxiety level during the blood collection procedures.
Methods: This randomized controlled experimental study was carried out with 134 children in the 5-10 age group in the pediatric blood collection unit of a Training and Research Hospital between August and November 2018. In the study, nonpharmacological methods were applied to the children in the experimental groups (Music Group (n=33), Kaleidoscope Group (n=36), Video Group (n=31). The routine blood collection procedure was used for the children in the control group (n=34). The data were collected using the "Introductory Information Form", "Children's Fear and Anxiety Scale (CFAS)", and the "Wong-Baker Faces Pain Rating Scale (WB-FPRS)".
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| music group | Experimental | Other: music groupThe children in the groups were distracted by listening music 2 minutes before venipuncture, until the process was over. |
| kaleidescope group | Experimental | Other: kaleidoscope groupThe children in the groups were distracted by kaleidoscope 2 minutes before the blood collection, until the process was over. |
| video group | Experimental | Other: video groupThe children in the groups were distracted by watching cartoon 2 minutes before the blood collection, until the process was over. |
| control group | No intervention | –No intervention was made to children in the control group |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- being healthy
- ability to express himself/herself verbally
- no analgesic taken in the last 6 hours
- having no visual or auditory problems
Key exclusion criteria (3 listed)
- chronic disease
- mental disease
- neurological disease
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 |
|---|---|---|
| music groupThe children in the groups were distracted by music 2 minutes before venipuncture, until the process was over | Other | music group |
| kaleidoscope groupThe children in the groups were distracted by kaleidoscope 2 minutes before venipuncture, until the process was over | Other | kaleidescope group |
| video groupThe children in the groups were distracted by watching video 2 minutes before venipuncture, until the process was over | Other | video group |
Primary outcome
Children Fear Scale
Time frame: 1 minute
The Children Fear Scale was used to evaluate the children's fear and anxiety. Children Fear Scale is a 0-4 scale, showing five faces that range from a neutral expression (0 = no anxiety) to a frightened face (4 = severe anxiety). Preprocedural and procedural pain, and anxiety were evaluated
Wong Baker Face Pain Scale
Time frame: 1 minute
The Wong Baker Faces scale is a 0-10 scale. Six faces on the cards show a range of emotions from a smiling face (0 very happy/no pain) to a crying face (10 'hurts worst').
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 Oct 2019.
- 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.
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 music group, kaleidoscope group and video group in people with Acute Pain and Nursing Caries, 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 4 inclusion and 3 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 Oct 2019. 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 Fear Scale (time frame: 1 minute). The study lists 2 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 15 Oct 2019.