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

Pruritus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04415034
• Other study ID #: 0920/UN2.F1/ETIK/2018
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: September 30, 2018

Study information

• Verified date: May 2020
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Lice Infestations
• Pediculus Capitis
• Pruritus

Intervention

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

Locations

Country	Name	City	State
Indonesia	Pesantren Al Hidayah Cibinong	Bogor	Jawa Barat

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pruritus severity (1)	Pruritus severity evaluated by visual analog scale (VAS)	Baseline, during examination
Primary	Pruritus severity (2)	Pruritus severity evaluated by 5-D itch scale	Baseline, during examination