- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04924023
The Effect of Using a Kaleidoscope During Central Venous Catheter Dressing Changes in Children With Cancer
The Effect of Using a Kaleidoscope During Central Venous Catheter Dressing Changes on Anxiety and Pain in Children With Cancer: A Randomised Controlled Study
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
This was a randomised controlled trial with 60 children aged 6-12 diagnosed with cancer who were placed either in a kaleidoscope group (n=30) or a control group (n=30). Each child's anxiety was evaluated by the child using the Child Fear Scale before, during and after a central venous catheter dressing procedure, and each child's pain during and after the procedure was evaluated by the child using the Wong-Baker Faces Pain Rating Scale (WB-FACES). Each child's heart rate and oxygen saturation were measured with a pulse oximeter device before, during and after central venous catheter dressing.
The children in kaleidoscope group looked into the kaleidoscope and slowly turned it. This distraction procedure began immediately before the central venous catheter dressing and continued until it was finished.
No intervention was performed to reduce pain and anxiety for children in the control group.
Parents accompanied their children during the procedure in both groups.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Burdur, Kalkon
- Pınar BEKAR
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- a cancer diagnosis,
- having a central venous catheter,
- 6-12 years old,
- not having taken any analgesics in the 6 hours before the central venous catheter dressing, -being in a non-terminal phase of the disease,
- absence of neutropenia,
- volunteering to participate in the study,
- the absence of any health problems that prevent communication in the parent or the child.
Exclusion Criteria:
-the reporting of pain for another reason at the time of the central venous catheter dressing.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Kaleidoscope Group
Children in this group were told what a kaleidoscope is and how to use it before their central venous catheter dressing.
The children were then asked if they would like to look into the kaleidoscope.
The children looked into the kaleidoscope and slowly turned it.
The researcher asked the children about the colours and shapes seen inside the kaleidoscope.
This distraction procedure began immediately before the central venous catheter dressing and continued until it was finished.
The kaleidoscope was disinfected before each use.
A kaleidoscope was provided for all children in this group by the same researcher.
Parents accompanied their children during the catheter dressing.
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The children looked into the kaleidoscope and slowly turned it.
The researcher asked the children about the colours and shapes seen inside the kaleidoscope.
This distraction procedure began immediately before the central venous catheter dressing and continued until it was finished.
|
Inget ingripande: Control Group
No intervention was performed to reduce pain and anxiety for children in the control group.
Parents accompanied their children during the procedure.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Wong-Baker FACES Pain Rating Scale (WB-FACES)
Tidsram: 5 MONTHS
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The Wong-Baker Faces Pain Rating Scale (WB-FACES) is used to evaluate pain levels in children.
This numeric rating scale ranges from 0 to 10 and is represented by faces that display emotions ranging from smiling (0 = very happy or no pain) to crying (10 = the worst pain).
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5 MONTHS
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Children's Fear Scale (CFS)
Tidsram: 5 MONTHS
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The Children's Fear Scale (CFS) is used to evaluate anxiety levels in children.
It consists of five facial expressions representing a range from no anxiety (0) to severe anxiety (4).
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5 MONTHS
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Heart Rate
Tidsram: 5 MONTHS
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The heart rate and oxygen saturation values of the children in both groups were measured and recorded by the researcher 3 minutes before the procedure, during the procedure and 5 minutes after the procedure using a pulse oximeter device.
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5 MONTHS
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Oxygen Saturation
Tidsram: 5 MONTHS
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The heart rate and oxygen saturation values of the children in both groups were measured and recorded by the researcher 3 minutes before the procedure, during the procedure and 5 minutes after the procedure using a pulse oximeter device.
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5 MONTHS
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Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Emine EFE, Prof.Dr., Akdeniz University, Department of Child Health and Disease Nursing
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KAEK-791
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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