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.

Study Overview

• Status: Completed
• Conditions: Pruritus; Pediculus Capitis
• Intervention / Treatment: Other: VAS and 5-D itch pruritus assessment

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 357

Contacts and Locations

Study Locations

• Indonesia
  • Jawa Barat
    • Bogor, Jawa Barat, Indonesia
      • Pesantren Al Hidayah Cibinong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects with pediculosis capitis

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pediculosis capitis; Subjects with pediculosis capitis based on the findings of eggs, larva, or an adult parasite on the scalp or in the hair	Other: VAS and 5-D itch pruritus assessment; All subjects were evaluated for presence of pruritus using VAS and 5-D itch scale

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pruritus severity (1)	Pruritus severity evaluated by visual analog scale (VAS)	Baseline, during examination
Pruritus severity (2)	Pruritus severity evaluated by 5-D itch scale	Baseline, during examination

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Principal Investigator: Sandra Widaty, MD, PhD, Department of Dermatology and Venereology, Faculty of Medicine Universitas Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: May 27, 2020
• First Submitted That Met QC Criteria: May 30, 2020
• First Posted (Actual): June 4, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: May 30, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Quality of life; Pediculosis capitis; Scalp pruritus; VAS scale; 5-D itch scale
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Parasitic Diseases; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Skin Manifestations; Lice Infestations; Pruritus
• Other Study ID Numbers: 0920/UN2.F1/ETIK/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No