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Completed

NCT Number: NCT04415034

Scalp Pruritus Measurement Using Visual Analog Scale and 5-d Itch Scale in Children With Pediculosis Capitis

Pediculosis capitis is a parasitic infestation that can cause scalp pruritus and quality of life disturbances. There are two objective measurement for pruritus, visual analog scale (VAS) and 5-D itch scale, which can assess the severity of the scalp pruritus and the latter can also asses the quality of life affected by pruritus. Even though VAS can not be used to evaluate the impact of pruritus on quality of life, it is very easy to use while 5-D itch scale is complex and not child-friendly.

The aim of this study is to determine the relationship between two different pruritus scales and to establish validity of pruritus VAS scale in evaluating quality of life in children with pediculosis capitis. We compare two pruritus scale on students with pediculosis of two boarding school in Bogor, West Java, Indonesia.

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Key information

Age range

11 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pesantren Al Hidayah Cibinong

Bogor, West Java, Indonesia

About this study

This study used cross sectional design study.

Subjects with eligible criteria were included and informed consent from the parents or legal guardian were obtained.

The diagnosis of pediculosis capitis was made based on the findings of eggs, larva, or an adult parasite on the scalp or in the hair of the students. All subjects were asked for both VAS and 5-D itch scale.The VAS is categorized into five groups based on the point, as follows: 0 for no pruritus, <3 for mild pruritus, ≥ 3 - <7 for moderate pruritus, ≥ 7 - <9 for severe pruritus, and ≥ 9 for very severe pruritus. The 5-D itch scale consists of five parameters: duration, degree, direction, disability (sleep, leisure/social activities, housework/errands, work/school), and distribution of the pruritus with points ranging from one to five.

Data were recorded for statistical analysis, a chi-square test was used to determine the relationship between two categorical variables. The correlation coefficient between the VAS and 5-D itch scale was calculated using Spearman's rank correlation

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Students studying in Junior high school at Boarding School in Bogor with medium length hair who were clinically diagnosed with pediculosis capitis
  • Willingness to participate as a research subject (to be interviewed and undergo physical examination), and after being explained the details of the study, granted the headmaster permission to sign consent in their name (informed assent)

Exclusion criteria

  • Chemical treatment of PC within 10 days before the trial
  • History of permethrin hypersensitivity
  • Unwillingness to participate as a research subject
  • Mild-to-severe secondary infection
  • Long or short hair

Treatment and study plan

VAS and 5-D itch pruritus assessment

Other

All subjects were evaluated for presence of pruritus using VAS and 5-D itch scale

Primary outcomes

  1. Pruritus severity (1)

    Time frame: Baseline, during examination

    Pruritus severity evaluated by visual analog scale (VAS)

  2. Pruritus severity (2)

    Time frame: Baseline, during examination

    Pruritus severity evaluated by 5-D itch scale

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 4, 2020
Registry last updated
Jun 4, 2020

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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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