PainRCTNCT06826352
Effects of Active and Passive Distraction Methods on Children's Pain, Fear and Anxiety
A study testing Active Distraction and Passive Distraction in people with Pain and Fear, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Background: It is important that reduce children's pain, fear, and anxiety during the invasive procedures for building effective communication with children and their parents. Knowing the effective methods will be helpful to use in the pediatric clinical. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- What is being tested?
- Active Distraction and Passive Distraction
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Nov 2019to 8 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- between the ages 3-7 years
- first invasive procedures
- children do not have visual and auditory problems that prevent them from applying the scales
- developed the child's counting skills
- absence of developmental delay in language development
- absence of pain in the child before the procedure
Who cannot join
- second invasive procedures
- the parent didn't want to be voluntarily participate
- the child didn't want to be voluntarily participate
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul University - Cerrahpasa
Istanbul, Şişli, 34381
About this study
Official title: The Effects of Active and Passive Distraction Methods on Children's Pain, Fear and Anxiety During Invasive Procedures: a Randomized Controlled Clinical Trial
Background:
It is important that reduce children's pain, fear, and anxiety during the invasive procedures for building effective communication with children and their parents. Knowing the effective methods will be helpful to use in the pediatric clinical.
Read more
Objective:
This study aimed to determine the effects of watching cartoons, a passive distraction method and playing video games, an active distraction method, on the pain, fear and anxiety of 3- to 7-year-old children before, during and after invasive procedures.
Design:
A randomized controlled clinical trial
Setting(s):
General pediatric service of a training and research hospital in Istanbul
Participants:
The study sample included 105 children who were 3- to 7-years-old inpatients. The children were randomly assigned to the control (n=35), cartoon (n=35) and video game (n=35) groups.
Methods:
The data were collected using an introductory information form, the Oucher Pain Scale, the Children's State Anxiety Scale, and the Children's Fear Scale between November 26, 2019 and January 8, 2020. Data analysis was performed with SPSS software using the chi-squared test, and one-way and repeated measures ANOVA.
Read the detailed description
The randomized controlled experimental study involved 105 children hospitalized in the general pediatric service from November 26, 2019, to January 8, 2020. All participants met the inclusion criteria and provided voluntary consent, along with their parents. The children will randomly be assigned to control and experimental groups using sealed envelopes, ensuring an unbiased selection process. Each of the three groups comprised 35 children: one control group receiving routine nursing practices and two experimental groups receiving routine nursing practices supplemented by either a passive distraction method (watching cartoons) or an active distraction method (playing video games). Data collection utilized several instruments, including The Information Form, The Oucher Pain Scale, The Children's State Anxiety Scale, and The Children's Fear Scale.
Before the data collection process:
The study's objectives will be thoroughly explained to the children and their parents in with written consent obtained from participations' parents. Those who consented will be randomly assigned to with another nurse. The children in the cartoon group chose a cartoon, while those in the video game group select a video game
Data Collection Tools included:
- The Introductory Information Form: Comprising 12 questions regarding the patients' demographic information and the three scales utilized in the study.
- The Oucher Pain Scale: Developed to assess children's pain levels, featuring six facial expressions that depict a spectrum of pain severity from "no pain" to "worst possible pain," providing a visual representation of pain.
- The Children's State Anxiety Scale (CSAS): A visual scale designed for children aged 4 to 10, resembling a thermometer with a bulb at the bottom and ten horizontal lines. Children are instructed to indicate their level of anxiety or nervousness by placing a marker on the scale.
- The Children's Fear Scale: This scale assesses children's fear levels through five facial expressions, ranging from a neutral face (0 = no anxiety) to a fearful face (4 = severe anxiety). It is primarily designed for children aged 5 to 10 but can be utilized for younger children with adequate language development.
Protocol:
There will be 3 groups. One of the groups will be a control group. The others are interventions group. One of intervention group is the passive distraction intervention which included watching cartoons. The other intervention group is the active distraction intervention which included playing video by mobile phone. During this method one of the nurses (not included the research) will be apply intravenous procedure.
Control Group: Children in the control group will be accompanied by a parent to the procedure room, where participants' vital signs will be recorded. Routine nursing practices, including bloodletting and intravenous procedure establishment, will be performed without any distraction methods. Pain, fear, and anxiety levels will be assessed by investigators two minutes before, during, and two minutes after the procedure.
Intervention Groups:
Passive Distractive Intervention Group Passive intervention group procedure is included cartoon watching. Children, in the Passive Distractive Intervention Group, will be accompanied by a parent to the procedure room, where participants' vital signs will be recorded. After that participations will be start watching cartoon, pain, fear, and anxiety levels will be measured at the same intervals as the control group, with observational recordings parameters made during the procedure. Parameters two minutes before, during, and two minutes after the procedure will be recorded by investigators to evaluate the overall impact of the distraction methods on pain, anxiety, and fear.
Cartoon Content: Prior to the procedure, children in the cartoon group select from a list of options, including Pepee, Niloya, Tom and Jerry, and Masha and The Bear. Cartoons time lapse is approximately 12 minutes. Participation begins to watch cartoon two minutes before the procedure and continued until its completion.
Active Distractive Intervention Group Children, in the Active Distractive Intervention Group, will be accompanied by a parent to the procedure room, where participants' vital signs will be recorded. Same procedure will be applied in this group. The participant will play the video with the hand he/she chooses to prevent the nurse's intravenous administration. Participants select the game, have no fixed time limits and continue until a play error occurred. Children can restart the game until the procedure concluded. Before the two minutes procedure the video will be started by participations and the parameters will be recorded two minutes before, during, and two minutes after the procedure by investigators Video Game Content: Children in the video game group were recommended games playable with one hand, such as Red Ball, Subway Surfers, Candy Crush Saga, and Wood Block Puzzle.
Children's pain, fear, and anxiety levels will be assessed using the Oucher Pain Scale, the Children's State Anxiety Scale, and the Children's Fear Scale before, during, and after the procedure. Vital signs, including pulse and oxygen saturation, will be measured using pulse oximetry, while blood pressure was assessed with a sphygmomanometer and stethoscope.
Study Hypotheses:
- Ho: The active and passive distraction methods have no effect on children's pain, fear, and anxiety.
- H1: The active and passive distraction methods effectively reduce children's pain during invasive procedures.
- H2: The active and passive distraction methods effectively reduce children's fear during invasive procedures.
- H3: The active and passive distraction methods effectively reduce children's anxiety during invasive procedures.
- H4: The active distraction method is more effective than the passive distraction method.
- Being tested
- Active Distraction, Passive Distraction
- Keywords
- pain, anxiety, fear, inpatient, child, video games, cartoons, clinical trial
- 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.
Active DistractionBehavioural
The video games will be played by children during the procedure.
Passive DistractionBehavioural
The cartoons will be selected by the children related to their interests. The cartoons are included Pepee, Niloya, Tom and Jerry, Masha and The Bear and others.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | There will be no intervention, just only an intravenous procedure will be applied by the nurse. |
| Active Distraction | Experimental | The active distraction includes video games. In this group, children play video games during the procedure. Receives: Behavioral: Active Distraction |
| Passive Distraction | Experimental | Participation will be watch cartoon. Receives: Behavioral: Passive Distraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Oucher Pain Scale
Zero is equivalent to no pain and 10 indicates the worst possible pain.
Measured: Pain score will be decrease during the procedure within the 3 minutues.
Secondary outcomes (1)
The Children's State Anxiety Scale
Zero is equivalent to no anxiety and 10 indicates the highest possible anxiety.
Measured: State Anxiety level will be decrease during the procedure within the 3 minutues.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start26 Nov 2019
- Primary completion8 Jan 2020
- Study completion8 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayse Gokoglu, Istanbul University - Cerrahpasa
- Investigators
- Özge Sukut, PhD, Study director, IUC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06826352
- Sponsor's protocol ID
- B.10.1.TKH.4.34.H.GP.0.01/212
- Acronym
- RCT
- Status last verified
- Feb 2025
- First submitted
- 10 Aug 2021
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ersig AL, Kleiber C, McCarthy AM, Hanrahan K. Validation of a clinically useful measure of children's state anxiety before medical procedures. J Spec Pediatr Nurs. 2013 Oct;18(4):311-9. doi: 10.1111/jspn.12042. Epub 2013 Jun 25.
PubMed 24094126Gerçeker GÖ, Ayar D, Özdemir Z, Bektaş M. Çocuk Anksiyete Skalası-Durumluluk ve Çocuk Korku Ölçeğinin Türk Diline Kazandırılması. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 2018; 11(1), 9-13.
McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
PubMed 21806301Beyer JE, Denyes MJ, Villarruel AM. The creation, validation, and continuing development of the Oucher: a measure of pain intensity in children. J Pediatr Nurs. 1992 Oct;7(5):335-46.
PubMed 1479552Gokoglu A, Sukut O. Should I play or should I watch: the effects of active and passive distraction methods on children's pain, fear and anxiety during invasive procedures: a randomized controlled clinical trial. BMC Pediatr. 2025 Oct 28;25(1):875. doi: 10.1186/s12887-025-06188-1.
PubMed 41152799
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Active and Passive Distraction Methods on Children's Pain, Fear and Anxiety During Invasive Procedures: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06826352
- Acronym / sponsor ID
- RCT / B.10.1.TKH.4.34.H.GP.0.01/212
- Keywords
- pain, anxiety, fear, inpatient, child, video games, cartoons, clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 8 Jan 2020 (actual)
- Study completion
- 8 Jan 2020 (actual)
- First posted
- 13 Feb 2025 (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.
Background:
It is important that reduce children's pain, fear, and anxiety during the invasive procedures for building effective communication with children and their parents. Knowing the effective methods will be helpful to use in the pediatric clinical.
Objective:
This study aimed to determine the effects of watching cartoons, a passive distraction method and playing video games, an active distraction method, on the pain, fear and anxiety of 3- to 7-year-old children before, during and after invasive procedures.
Design:
A randomized controlled clinical trial
Setting(s):
General pediatric service of a training and research hospital in Istanbul
Participants:
The study sample included 105 children who were 3- to 7-years-old inpatients. The children were randomly assigned to the control (n=35), cartoon (n=35) and video game (n=35) groups.
Methods:
The data were collected using an introductory information form, the Oucher Pain Scale, the Children's State Anxiety Scale, and the Children's Fear Scale between November 26, 2019 and January 8, 2020. Data analysis was performed with SPSS software using the chi-squared test, and one-way and repeated measures ANOVA.
Detailed description
The randomized controlled experimental study involved 105 children hospitalized in the general pediatric service from November 26, 2019, to January 8, 2020. All participants met the inclusion criteria and provided voluntary consent, along with their parents. The children will randomly be assigned to control and experimental groups using sealed envelopes, ensuring an unbiased selection process. Each of the three groups comprised 35 children: one control group receiving routine nursing practices and two experimental groups receiving routine nursing practices supplemented by either a passive distraction method (watching cartoons) or an active distraction method (playing video games). Data collection utilized several instruments, including The Information Form, The Oucher Pain Scale, The Children's State Anxiety Scale, and The Children's Fear Scale.
Before the data collection process:
The study's objectives will be thoroughly explained to the children and their parents in with written consent obtained from participations' parents. Those who consented will be randomly assigned to with another nurse. The children in the cartoon group chose a cartoon, while those in the video game group select a video game
Data Collection Tools included:
- The Introductory Information Form: Comprising 12 questions regarding the patients' demographic information and the three scales utilized in the study.
- The Oucher Pain Scale: Developed to assess children's pain levels, featuring six facial expressions that depict a spectrum of pain severity from "no pain" to "worst possible pain," providing a visual representation of pain.
- The Children's State Anxiety Scale (CSAS): A visual scale designed for children aged 4 to 10, resembling a thermometer with a bulb at the bottom and ten horizontal lines. Children are instructed to indicate their level of anxiety or nervousness by placing a marker on the scale.
- The Children's Fear Scale: This scale assesses children's fear levels through five facial expressions, ranging from a neutral face (0 = no anxiety) to a fearful face (4 = severe anxiety). It is primarily designed for children aged 5 to 10 but can be utilized for younger children with adequate language development.
Protocol:
There will be 3 groups. One of the groups will be a control group. The others are interventions group. One of intervention group is the passive distraction intervention which included watching cartoons. The other intervention group is the active distraction intervention which included playing video by mobile phone. During this method one of the nurses (not included the research) will be apply intravenous procedure.
Control Group: Children in the control group will be accompanied by a parent to the procedure room, where participants' vital signs will be recorded. Routine nursing practices, including bloodletting and intravenous procedure establishment, will be performed without any distraction methods. Pain, fear, and anxiety levels will be assessed by investigators two minutes before, during, and two minutes after the procedure.
Intervention Groups:
Passive Distractive Intervention Group Passive intervention group procedure is included cartoon watching. Children, in the Passive Distractive Intervention Group, will be accompanied by a parent to the procedure room, where participants' vital signs will be recorded. After that participations will be start watching cartoon, pain, fear, and anxiety levels will be measured at the same intervals as the control group, with observational recordings parameters made during the procedure. Parameters two minutes before, during, and two minutes after the procedure will be recorded by investigators to evaluate the overall impact of the distraction methods on pain, anxiety, and fear.
Cartoon Content: Prior to the procedure, children in the cartoon group select from a list of options, including Pepee, Niloya, Tom and Jerry, and Masha and The Bear. Cartoons time lapse is approximately 12 minutes. Participation begins to watch cartoon two minutes before the procedure and continued until its completion.
Active Distractive Intervention Group Children, in the Active Distractive Intervention Group, will be accompanied by a parent to the procedure room, where participants' vital signs will be recorded. Same procedure will be applied in this group. The participant will play the video with the hand he/she chooses to prevent the nurse's intravenous administration. Participants select the game, have no fixed time limits and continue until a play error occurred. Children can restart the game until the procedure concluded. Before the two minutes procedure the video will be started by participations and the parameters will be recorded two minutes before, during, and two minutes after the procedure by investigators Video Game Content: Children in the video game group were recommended games playable with one hand, such as Red Ball, Subway Surfers, Candy Crush Saga, and Wood Block Puzzle.
Children's pain, fear, and anxiety levels will be assessed using the Oucher Pain Scale, the Children's State Anxiety Scale, and the Children's Fear Scale before, during, and after the procedure. Vital signs, including pulse and oxygen saturation, will be measured using pulse oximetry, while blood pressure was assessed with a sphygmomanometer and stethoscope.
Study Hypotheses:
- Ho: The active and passive distraction methods have no effect on children's pain, fear, and anxiety.
- H1: The active and passive distraction methods effectively reduce children's pain during invasive procedures.
- H2: The active and passive distraction methods effectively reduce children's fear during invasive procedures.
- H3: The active and passive distraction methods effectively reduce children's anxiety during invasive procedures.
- H4: The active distraction method is more effective than the passive distraction method.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –There will be no intervention, just only an intravenous procedure will be applied by the nurse. |
| Active Distraction | Experimental | Behavioral: Active DistractionThe active distraction includes video games. In this group, children play video games during the procedure. |
| Passive Distraction | Experimental | Behavioral: Passive DistractionParticipation will be watch cartoon. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- between the ages 3-7 years
- first invasive procedures
- children do not have visual and auditory problems that prevent them from applying the scales
- developed the child's counting skills
- absence of developmental delay in language development
Key exclusion criteria (3 listed)
- second invasive procedures
- the parent didn't want to be voluntarily participate
- the child didn't want to be voluntarily participate
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 |
|---|---|---|
| Active DistractionThe video games will be played by children during the procedure. | Behavioural | Active Distraction |
| Passive DistractionThe cartoons will be selected by the children related to their interests. The cartoons are included Pepee, Niloya, Tom and Jerry, Masha and The Bear and others. | Behavioural | Passive Distraction |
Primary outcome
The Oucher Pain Scale
Time frame: Pain score will be decrease during the procedure within the 3 minutues.
Zero is equivalent to no pain and 10 indicates the worst possible pain.
1 secondary outcome
The Children's State Anxiety Scale
Time frame: State Anxiety level will be decrease during the procedure within the 3 minutues.
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 13 Feb 2025.
- Background: PubMed 24094126Ersig AL, Kleiber C, McCarthy AM, Hanrahan K. Validation of a clinically useful measure of children's state anxiety before medical procedures. J Spec Pediatr Nurs. 2013 Oct;18(4):311-9. doi: 10.1111/jspn.12042. Epub 2013 Jun 25.
- BackgroundGerçeker GÖ, Ayar D, Özdemir Z, Bektaş M. Çocuk Anksiyete Skalası-Durumluluk ve Çocuk Korku Ölçeğinin Türk Diline Kazandırılması. Dokuz Eylül Üniversitesi Hemşirelik Fakültesi Elektronik Dergisi, 2018; 11(1), 9-13.
- Background: PubMed 21806301McMurtry CM, Noel M, Chambers CT, McGrath PJ. Children's fear during procedural pain: preliminary investigation of the Children's Fear Scale. Health Psychol. 2011 Nov;30(6):780-8. doi: 10.1037/a0024817. Epub 2011 Aug 1.
- Background: PubMed 1479552Beyer JE, Denyes MJ, Villarruel AM. The creation, validation, and continuing development of the Oucher: a measure of pain intensity in children. J Pediatr Nurs. 1992 Oct;7(5):335-46.
- Derived from this study: PubMed 41152799Gokoglu A, Sukut O. Should I play or should I watch: the effects of active and passive distraction methods on children's pain, fear and anxiety during invasive procedures: a randomized controlled clinical trial. BMC Pediatr. 2025 Oct 28;25(1):875. doi: 10.1186/s12887-025-06188-1.
- 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.
Özge Sukut, PhD study director
IUC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Distraction and Passive Distraction in people with Pain and Fear, run by Istanbul University - Cerrahpasa 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 6 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 13 Feb 2025. 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?
The Oucher Pain Scale (time frame: Pain score will be decrease during the procedure within the 3 minutues.). 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 NCT06826352, which also lists 5 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 13 Feb 2025.