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

NCT04415034 | Completed

• 1 other identifier: 0920/UN2.F1/ETIK/2018
• Study Type: observational
• Target: 357
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediculus Capitis; Pruritus

Keywords

Pediculosis capitis; Scalp pruritus; VAS scale; 5-D itch scale; Quality of life

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Interventions

VAS and 5-D itch pruritus assessment OTHER

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

Pediculosis capitis

Eligibility Criteria

• Age: 11 Years - 18 Years
• Gender Eligibility Details: Female students
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with pediculosis capitis

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Pesantren Al Hidayah Cibinong

Bogor, West Java, Indonesia

Location

MeSH Terms

Conditions

Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sandra Widaty, MD, PhD

  Department of Dermatology and Venereology, Faculty of Medicine Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 4, 2020
• Study Start: September 1, 2018
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: June 4, 2020

Record last verified: 2020-05

Locations

ID (1)