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Pain, ProceduralNCT05546463

The Effects of Playing Digital Games on Children's Pain, Fear and Anxiety Levels During Suturing

A study testing Digital games in people with Pain, Procedural and Fear of Needles, run by Izmir University of Economics 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

The aim was to determine the effects of digital game play on children's pain, fear and anxiety levels during suturing. Data was obtained from 84 children between the ages of 8-17 at the Pediatric Emergency Department between 16 January and 19 March 2020, using the Socio-Demographic and Clinical Characteristics Form… Read more about this study

Who is it for?
Ages 8 to 17 years
Conditions the study is for
Pain, Procedural, Fear of Needles, Anxiety State
What is being tested?
Digital games
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteTurkey (Türkiye)
Study dates
16 Jan 2020to 19 Mar 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 8 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Having no psychological diagnoses.
  • Having no problems in vision, hearing, or speech.
  • Speaking and understanding Turkish.
  • That the number of sutures is 3 or more.
  • That the suture procedure is performing under local anesthesia.
  • That they assent to participate in the study.

Who cannot join

  • Refusing to play digital games or stop playing before the process ends.
  • Having a physical problem that prevents playing digital games.
  • Being too agitated to communicate with the child.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Health Sciences University Izmir Tepecik Education and Research Hospital

    Izmir

Other trials in Turkey (Türkiye)

About this study

Official title: The Effects of Playing Digital Games on Children's Pain, Fear and Anxiety Levels During Suturing: A Randomized Controlled Study

The aim was to determine the effects of digital game play on children's pain, fear and anxiety levels during suturing.

Data was obtained from 84 children between the ages of 8-17 at the Pediatric Emergency Department between 16 January and 19 March 2020, using the Socio-Demographic and Clinical Characteristics Form, the Wong-Baker Faces Pain Rating Scale (WBFPS), the Visual Analogue Scale (VAS), the Fear of Medical Procedure Scale (FMPS), and the State-Trait Anxiety Inventory for Children (STAI-CH). While the study group (n=42) played digital games during the suturing procedure, the control group (n=42) did not play digital games.

Read the detailed description

This study has the potential to contribute to the literature on the effects of playing digital games on the pain, fear, and anxiety levels that children experience during suturing.

Materials and Methods

Design, setting, and sample size:

The data of the randomized controlled study were collected in the Pediatric Emergency Department (PED) of the Training and Research Hospital between 16 January and 19 March 2020. The population of the study are children between the ages of 8 and 17 who were sutured in the PED. Random sampling method was used for participant selection. The size of the sample was determined by the power analysis of the GPower 3.1.9.4 program as 84 children with 0.05 error, 0.95 confidence interval, and 0.5 effect size.

Participants and randomization:

The inclusion criteria were that children were between the ages of 8-17 and had no psychological diagnoses, had no problems in vision, hearing, or speech, spoke and understood Turkish, that the number of sutures was 3 or more (generally, local anesthesia is not applied to 1-2 sutures), that the suture procedure was performed under local anesthesia, and that they assented to participate in the study. Exclusion criteria were refusing to play digital games or stop playing before the process ends, having a physical problem that prevents playing digital games, being too agitated to communicate with the child. Children were divided into two groups (intervention group: n=42 and control group: n=42), using the block of four randomization methods among those who met the inclusion criteria, according to their order of admission to the PED. The children in the intervention and control groups did not know which group they were in and did not encounter each other. First researcher is staff member within the PED, and performed the randomization.

Ethical Approach:

Permission was obtained from Ethics Committee of University (Issue No: excluded double-blind review) and the institution where the research would be conducted (Date:15/01/2020). Original signed consent was obtained from all parents who assented to participate in the study through the Information and Informed Consent Form. Verbal consent was obtained from the children assented. A health professional acting as a witness signed a form to this effect.

Data Collection Tools:

Research data were collected using "Socio-Demographic and Clinical Characteristics Form", "Wong-Baker Faces Pain Rating Scale", "Visual Analogue Scale", "State-Trait Anxiety Inventory for Children", and "Fear for Medical Procedures Scale". First researcher informed the children and their parents about the tools, and collect the data. The average data collection time was 30 minutes. Data were obtained using face-to-face interviews and observation from children.

Socio-Demographic and Clinical Characteristics Form:

This form consists of a total of 23 questions eliciting information, including on age, gender, previous digital game playing status, number of suturing, and duration of suturing, created by the researchers in accordance with the literature.

Wong-Baker Faces Pain Rating Scale (WBFPS):

The Faces Pain Rating Scale, developed by Wong and Baker, is a hand-drawn scale that includes six facial expressions ranging from smiling to crying, and is recommended for use for children aged 3 years and older. Scoring is defined as 0 = no hurt, 2 = hurts little bit, 4 = hurts little more, 6 = hurts even more, 8 = hurts whole lot, 10 = hurts worst.

Visual Analogue Scale (VAS):

This is a 100 mm long horizontal line with the words "no pain" and "severe pain" at either end. It is suitable for school-age children. The child is asked to mark the point showing the intensity of pain felt at that moment.

Fear of Medical Procedures Scale:

Fear of Medical Procedures Scale (FMPS) was developed by Bloom et al. in 1985 to assess children's fears associated with medical procedures and practices. The scale consists of 29 questions evaluating the fear of medical procedures. The scale consists of 4 sub-dimensions, including operational, personal, environmental, and interpersonal items. In the three-point Likert-type scale, for each question, children are asked to choose one of the expressions "no fear" (1 point), "moderate fear" (2 points), "high fear" (3 points). Scores range between 29 and 87. The validity and reliability study in Türkiye was conducted among children aged 7-14 by Alak in 1993, and the reliability coefficient was found to be .93. In our study, the Cronbach Alpha value of the scale was found to be .93.

State-Trait Anxiety Inventory for Children:

State-Trait Anxiety Inventory for Children (STAI-CH) was developed by Spielberger in 1973 to measure the anxiety caused to children in particular situations perceived as a threat. In the trait anxiety scale, the children are asked to evaluate how they "generally" feel, and in the state anxiety scale, how they feel in the situation they are in "at that moment", and indicate one of three options. Possible scores range between 20 and 60. A higher score indicates greater anxiety. The validity and reliability study in Türkiye was conducted by Özusta in 1995 for children aged 9-12. In STAI-CH, the Cronbach Alpha coefficient of the state anxiety scale was found .82, and the Cronbach Alpha coefficient of the trait anxiety scale was .81. In our study, the Cronbach Alpha coefficient of the state anxiety scale was found .91, and the Cronbach Alpha coefficient of the trait anxiety scale was .78.

Procedure:

A digital game was played via iPad Air 2 32GB 9.7-inch wi-fi model tablet. The researcher created a folder with a range of selected games to appeal to different preferences. Children could choose from the following games: Word Travel, Talking Tom Candy Run, 384 Puzzles for Kids, Masha and The Bear, Subway Surfers, Head Ball 2 and Dream League Soccer".

During the suture procedure, the children in the intervention group played digital games, while the children in the control group did not. The routine practices of the clinic were carried out in both groups.

In the pre-procedure, the researcher completed the Socio-Demographic and Clinical Characteristics Form, with an explanation about WBFPS, VAS, FMPS, and STAI-CH. Families were allowed to stay with their children. Children in the intervention group began playing digital games about one minute before the local anesthesia procedure (Figure 1).

The children in the intervention group continued to play digital games throughout the suturing procedure. Children in all groups were asked to mark the pain they experienced during the procedure on the WBFPS and VAS. Parents were encouraged to stand next to the child during the process.

In post-procedure, children in all groups were asked to mark the pain experienced after suturing on the WBFPS and VAS. All children were asked to respond to the FMPS and STAI-CH (only state inventory) scales to measure the fear and anxiety experienced.

Statistical Analysis:

Licensed SPSS (Statistical Package for the Social Science) for Windows 25.0.0 package program was used for data analysis. The suitability of the data to the normal distribution was examined with the Kolmogorov-Smirnov test. Continuous variables are expressed as mean ± standard deviation. According to the results of the normality test, either the t-test or Mann-Whitney U test was used in independent groups for comparisons between groups. Intergroup comparisons of categorical variables, as for that, were performed using Pearson Chi-square test or Fisher Exact test. In group comparisons, t-test, Wilcoxon test, and multiple analysis of variance were used in repeated measurements in dependent groups. Tukey's test was used for Post-Hoc analysis with Bonferroni correction to determine which group caused the difference. The results were evaluated at a 95% confidence interval and p<0.05 significance level.

Being tested
Digital games
Medical subject headings
Pain, Procedural, Iatrophobia, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital gamesBehavioural

    A digital game was played via iPad Air 2 32GB 9.7-inch wi-fi model tablet. The researcher created a folder with a range of selected games to appeal to different preferences. Children could choose from the following games: Word Travel, Talking Tom Candy Run, 384 Puzzles for Kids, Masha and The Bear, Subway Surfers, Head Ball 2 and Dream League Soccer".

Study groups in NCT05546463
Study groupRoleWhat they receive
Intervention groupExperimentalDuring the suture procedure, the children in the intervention group played digital games. Children began playing digital games about one minute before the local anesthesia procedure, continued to play digital games throughout the suturing procedure.
Receives: Behavioral: Digital games
Control groupExperimentalDuring the suture procedure, the children in the control group did not play digital games.
Receives: Behavioral: Digital games

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Socio-Demographic and Clinical Characteristics

    Socio-Demographic and Clinical Characteristics Form:

    This form consists of a total of 23 questions eliciting information, including on age, gender, previous digital game playing status, number of suturing, and duration of suturing, created by the researchers in accordance with the literature.

    Measured: 2 months

  2. Pain score

    Pain score was determined using "Wong-Baker Faces Pain Rating Scale" and "Visual Analogue Scale".

    Wong-Baker Faces Pain Rating Scale:

    The Faces Pain Rating Scale, developed by Wong and Baker, is a hand-drawn scale that includes six facial expressions ranging from smiling to crying, and is recommended for use for children aged 3 years and older. Scoring is defined as 0 = no hurt, 2 = hurts little bit, 4 = hurts little more, 6 = hurts even more, 8 = hurts whole lot, 10 = hurts worst.

    Visual Analogue Scale:

    This is a 100 mm long horizontal line with the words "no pain" and "severe pain" at either end. It is suitable for school-age children. The child is asked to mark the point showing the intensity of pain felt at that moment.

    Measured: 2 months

  3. Anxiety score

    Anxiety score was determined using "State-Trait Anxiety Inventory for Children"

    State-Trait Anxiety Inventory for Children:

    State-Trait Anxiety Inventory for Children was developed by Spielberger in 1973 to measure the anxiety caused to children in particular situations perceived as a threat. In the trait anxiety scale, the children are asked to evaluate how they "generally" feel, and in the state anxiety scale, how they feel in the situation they are in "at that moment", and indicate one of three options. Possible scores range between 20 and 60. A higher score indicates greater anxiety. The validity and reliability study in Türkiye was conducted by Özusta in 1995 for children aged 9-12. In State-Trait Anxiety Inventory for Children, the Cronbach Alpha coefficient of the state anxiety scale was found .82, and the Cronbach Alpha coefficient of the trait anxiety scale was .81.

    Measured: 2 months

  4. Fear score

    Fear score was determined using "Fear for Medical Procedures Scale".

    Fear of Medical Procedures Scale:

    Fear of Medical Procedures Scale was developed by Bloom et al. in 1985 to assess children's fears associated with medical procedures and practices. The scale consists of 29 questions evaluating the fear of medical procedures. The scale consists of 4 sub-dimensions, including operational, personal, environmental, and interpersonal items. In the three-point Likert-type scale, for each question, children are asked to choose one of the expressions "no fear" (1 point), "moderate fear" (2 points), "high fear" (3 points). Scores range between 29 and 87. The validity and reliability study in Türkiye was conducted among children aged 7-14 by Alak in 1993, and the reliability coefficient was found to be .93.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2022
  2. Study start16 Jan 2020
  3. Primary completion19 Mar 2020
  4. Study completion19 Mar 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
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05546463
Sponsor's protocol ID
IzmirUEcon
Status last verified
Sep 2022
First submitted
6 Sep 2022
Last updated
19 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Digital games in people with Pain, Procedural and Fear of Needles, run by Izmir University of Economics 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 19 Sep 2022. 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?

Socio-Demographic and Clinical Characteristics (time frame: 2 months). The study lists 4 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 19 Sep 2022.

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