The Effects of Playing Digital Games on Children's Pain, Fear and Anxiety Levels During Suturing
Condition: Pain, Procedural; Fear of Needles; Anxiety State
MeSH terms: Pain, Procedural; Anxiety Disorders
Study type: Interventional

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, 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.
    

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.
    

Intervention name(s): Digital games
Intervention type(s): Behavioral
Intervention description(s): 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".
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care