The Impact of a Computer Network on Pediatric Pain and Anxiety A Randomized Controlled Clinical Tria

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The Impact of a Computer Network on Pediatric
Pain and Anxiety- A Randomized Controlled
Clinical Trial -
By Jackie Bender
Holden et al., Social Work in Health Care, Vol 36
(2), 2002.
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What is STARBRIGHT World?
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What can kids do on STARBRIGHT World?

• COMMUNICATE with other kids in hospitals in the
  US via
• Video-conferencing
• Chat Rooms
• Bulletin Boards
• Email

• GET ANSWERS to health-related questions.
• Interactive multimedia education programs

• PLAY games/ arts/ crafts

• Special Features
• Videos with Attitude
• Once Upon a Fairy Tale

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Mission of Starbright World

• SBW aims to promote
• Communication
• Distraction
• Information
• Self-expression
• Social support

• Resulting in
• Enhanced Quality of Life
• Reduction in Pain
• Reduction in Anxiety

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Rationale

• SBW is promoted as a form of CBT
• Cognitive Behavioral Therapy for Pain
• change perception of pain
• alter pain behaviour
• provide a sense of control over pain.

• Forms of CBT
• distraction, imagery, relaxation, hypnosis,
  biofeedback, calming self-talk, cognitive
  re-structuring.

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Study Objectives

• To test the impact of SBW vs the General
  Pediatric Milieu (GPM- control condition) on
  childrens self report of
• Pain intensity
• Pain Aversiveness (distress)
• Anxiety
• Satisfaction

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Study Design

• Within-Subject (n-of-1 crossover trial)
• Each subject exposed to both experimental and
  control conditions.
• Each subject serves as his/her own control.

• Restricted, Alternating treatment procedure
• Randomized treatment schedules were generated for
  each child prior to enrollment (BAAABBABBBBAB).
• Total of 41, 30 min treatment sessions
• Initial condition, of sessions in each
  condition and distribution of treatment
  conditions were randomly determined for each
  child.
• Limit of 6 consecutive sessions in either
  condition.

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Study Hypotheses

• Children will experience less pain intensity in
  the SBW condition.
• Children will experience less pain aversiveness
  in the SBW condition.
• Children will experience less anxiety in the SBW
  condition.

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Study Participants

• Children hospitalized at Mount Sinai in NY
• Ages 7-18
• Heterogeneous illnesses
• N 39
• F 20 girls
• M 19 boys

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Control Condition

• General Pediatric Milieu (GPM)
• Playroom activity
• Individual therapeutic play activity
• Family interaction
• Visits from family/ friends
• Eating
• Watching TV/ Video
• Reading
• Telephone
• Art activity

Q Is this control condition suitable?
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Outcome Measures

• Pain Intensity Coloured Analogue Scale (CAS)
• Score Range 0-10
• Pain Aversiveness Facial Analogue Scale (FAS)
• Score Range .04-.97
• Anxiety Visual Analogue Scale (VAS)
• Score Range 0-10
• Satisfaction Visual Analogue Scale (VAS)
• Score Range 0-100

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Measurement Procedure

• Ecological Momentary Assessment
• A method for collecting moment-by-moment data in
  real world settings.
• Immediate reporting minimizes recall and
  attendant biases.

The research assistant approached participants in
the middle of each 30-min treatment session and
asked them to rate their pain intensity, pain
aversiveness, and anxiety.
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Analysis Procedure

• Randomization tests of the mean difference
  between SBW and GPM conditions for the 3 outcome
  variables.
• Meta-analysis used to combine results to produce
  an estimate of the effect size across
  participants.
• Results of meta-analysis weighted by n to account
  for different number of observation points per
  participant.

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Results
Mean of PHASE A Mean of PHASE B p value
N A B
LR proportion of observations (in both
conditions combined) when participants reported
lowest possible rating (floor effects)
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Results
M Unweighted

• Wt weighted
• n1(diff)
• n

LR occurred 43, 38 and 20 of occasions.
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Conclusions

• In the SBW condition, children experienced
• less pain intensity
• less pain aversiveness
• less anxiety
• BUT!.. the results did not achieve statistical
  significance.
• Meta-analysis of mean differences (? 0.0166)
• Pain intensity 0.13 .528
• Pain aversiveness 0.040 .023
• Anxiety 0.10 .164
• Satisfaction Mean 89.4 SD14.3

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Study Limitations

• Convenience sample of children.
• Control condition not inert.
• Significant floor effects- restrict variability
  in findings and reduce chances of finding
  differences between groups.
• Children reported that they could not always link
  to other medical centres online.

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Questions for Discussion

• Why the need for a 3rd RCCT?
• Is the Control Condition suitable?
• What is the relevant component of the program
  producing the effect?
• Why are there significant floor effects and are
  the scales used adequate?
• Is the EMA procedure appropriate/ effective for
  assessing pain during a distraction task?
• Is SBW effective in reducing pain and anxiety?

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Future Directions

• What features of the program are more effective
  for certain age groups?
• What features of the program are producing the
  relevant effects.
• Assess baseline measures.
• Need for another RCCT with much larger sample
  size, and less variable control condition.