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

Sponsor
Indonesia University (Other)
Overall Status
Completed
CT.gov ID
NCT04415034
Collaborator
(none)
357
1
29
374.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
357 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Scalp Pruritus Measurement Using Visual Analog Scale and 5-d Itch Scale in Children With Pediculosis Capitis
Actual Study Start Date :
Sep 1, 2018
Actual Primary Completion Date :
Sep 30, 2018
Actual Study Completion Date :
Sep 30, 2018

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Pruritus severity (1) [Baseline, during examination]

    Pruritus severity evaluated by visual analog scale (VAS)

  2. Pruritus severity (2) [Baseline, during examination]

    Pruritus severity evaluated by 5-D itch scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pesantren Al Hidayah Cibinong Bogor Jawa Barat Indonesia

Sponsors and Collaborators

  • Indonesia University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. dr. Sandra Widaty, SpKK (K), Principal investigator, Indonesia University
ClinicalTrials.gov Identifier:
NCT04415034
Other Study ID Numbers:
  • 0920/UN2.F1/ETIK/2018
First Posted:
Jun 4, 2020
Last Update Posted:
Jun 4, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. dr. Sandra Widaty, SpKK (K), Principal investigator, Indonesia University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 4, 2020