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NCT Number: NCT06591195

Distraction As Multimodal Pain Management

A randomized controlled trial will be performed at the Ngwelezana Hospital, Empangeni, South Africa. Paediatric patients between the age of 5-12 years with minor and superficial partial thickness burn injuries who require dressing changes in the outpatient clinic, without sedation, will be randomized into two groups: the control group will receive standard practice of care which concerns a dressing change without any distraction methods, and the intervention group will receive distraction by use of a kaleidoscope as additional method for potential pain alleviation. Patients in both groups will receive paracetamol or non-steroidal anti-inflammatory drugs when required according to hospital protocol. The primary outcome will be the change in pain score from pre-procedural to pain score during the dressing change and will be analysed with a linear regression analysis. Additionally, sub analyses will be performed to evaluate potentially modifying factors on the treatment effect. This will also be evaluated with a linear regression analysis. This will be correlated with care giver and health care worker observational pain scores.

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Key information

Conditions

Pain, Acute Acute Pain Agnosia Burns Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pediatric ALL Perceptual Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Signs and Symptoms Wounds and Injuries

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric patients between the age of 5 and 12 years old with burn injuries requiring dressing changes in the outpatient clinic, who in regular practice (non-research setting) would not receive any analgesics other than paracetamol or a non-steroidal anti-inflammatory drug (NSAID);
  • Superficial partial thickness burns < 5% TBSA (total body surface area) at the time of injury
  • Only the first change of dressing is included

Exclusion criteria

  • Patients who underwent split skin grafts for their burns;
  • Patients on sedatives or anti-epileptics;
  • The use of pain-relieving medication other than paracetamol or NSAIDs;
  • If it is the patient's second presentation to Ngwelezana hospital's outpatient burns department
  • Painful additional injuries other than the burn injury;
  • Physical or mental impairments which make it impossible to adequately comply with the trial protocol. For example, visual impairments, impaired ability to communicate, psychological comorbidities, and burns that limit the use of a kaleidoscope (facial burns or burns to both hands)

Treatment and study plan

Distraction by use of kaleidoscope

Device

À kaleidoscope is an optical device consisting of mirrors that reflect images of bits of coloured glass in a symmetrical geometric design through a viewer.

A kaleidoscope was selected as the non-electronic method of distraction, because of its wide availability due to low costs, its evolving and colourful visual stimuli, the fact that is blocks out any visualisations from the environment when used properly, and because it requires active participation (i.e., greater attention) from the subject.

Primary outcomes

  1. The difference in patient-reported pain score

    Time frame: Baseline, before wound cleaning (0 minutes) and after dressing change (within 10 minutes)

    The patient-reported pain score after the dressing change minus the pain score before the procedure. This pain score is rated on the Wong-Baker FACES Pain Rating Scale from 0-10.

Secondary outcomes

  1. Observational pain score

    Time frame: During the dressing change procedure (0 minutes to 5 minutes)

    The observational pain score is measured during the dressing change on the Face, Legs, Activity, Cry and Consolability (FLACC) scale from 0 to 10. This score is corrected by the baseline (patiënt-reported) pain score before the dressing change.

  2. Global satisfaction with treatment

    Time frame: After dressing change (within 10 minutes)

    Global satisfaction about the treatment is assessed among the patient's caregiver and healthcare provider. Global satisfaction will be rated on a 1-5 scale based on the question: "Considering pain relief, side effects, and emotional status, how satisfied were you with the dressing change your child underwent?&#34;

Study contacts

Contact information is provided by the study sponsor or research team.

Frederike Haverkamp, MD, PhD

CONTACT

[email protected]

0031243610492

Ravi Naidoo, MD

CONTACT

[email protected]

0027 35 9017000

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

Distraction As Multimodal Pain Management for Children in Resource-constrained Settings (DISTRACT)

Acronym: DISTRACT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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