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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Conditions the study is for
Pain, Fear, Anxiety
What is being tested?
Active Distraction and Passive Distraction
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

Other trials in Turkey (Türkiye)

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:

  1. The Introductory Information Form: Comprising 12 questions regarding the patients' demographic information and the three scales utilized in the study.
  2. 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.
  3. 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.
  4. 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.
Conditions
Pain, Fear, Anxiety
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 groups in NCT06826352
Study groupRoleWhat they receive
Control GroupNo interventionThere will be no intervention, just only an intravenous procedure will be applied by the nurse.
Active DistractionExperimentalThe active distraction includes video games. In this group, children play video games during the procedure.
Receives: Behavioral: Active Distraction
Passive DistractionExperimentalParticipation 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.

  1. 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)
  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.

  1. First posted13 Feb 2025
  2. Study start26 Nov 2019
  3. Primary completion8 Jan 2020
  4. Study completion8 Jan 2020

Resources

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)
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 24094126
  • Gerçeker 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 21806301
  • Beyer 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 1479552
  • Gokoglu 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

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.

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