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Trial registered on ANZCTR

Registration number

ACTRN12618000091202

Ethics application status

Approved

Date submitted

11/09/2017

Date registered

19/01/2018

Date last updated

19/01/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

Impact of health education on recurrent infestation with head lice

Scientific title

Effectiveness of a school-based educational intervention on knowledge, attitude, and practices associated with Pediculosis capitis re-infestation

Secondary ID [1]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pediculosis capitis (head lice infestation)

Condition category

Condition code

Public Health

Health promotion/education

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

All the children with head lice in both control and intervention groups will be treated with pediculicide. The pediculicide that will be used is "Lice Clear" by Apex Pharma (Malaysia). It contains 4% Dimeticone, packed in a 75ml bottle. A plastic lice comb is also included in the packaging. They will applpy the pediculicide 2 times, 7 days apart. Methods of application is available in a printed form and will be supplied to all the students with head lice.

On top of the application of pediculicide, the intervention group will be given health education on Head lice infestation, prevention, and management.

The intervention is formulated based on the pilot study that was conducted on the knowledge, attitude and practices associated with Pediculosis capitis infestation and reinfestation among the primary school children in Hulu Langat District, Selangor, Malaysia. The intervention is aimed to:
i) improve knowledge of the students on Pediculosis capitis infestation particularly on identifying the head lice, recognizing the symptoms of infestation, diagnosis, prevention and management.
ii) encourage good behavior in preventing Pediculosis capitis infestation and reinfestation.
iii) instill good practices in the prevention and management of Pediculosis capitis infestation and reinfestation.

The intervention group receives the health education module whereas the control group is waitlisted and receives the similar health intervention module when the study period of the intervention group has been completed (after 6 weeks from the first visit by the researcher).

Contamination between the intervention and control groups is limited and controlled. This will be achieved via limiting interaction of the respondents by selecting two schools that are apart.

The health education module will consist of the followings:
a) One session of health talk, approximately 45minutes of health talk and 30 minutes of Q&A session. The health talk will be delivered by the researcher, a doctor who holds a master degree in Public Health (MPH).
The health talk will be given in the schools. It is intended for all students, especially for those with head lice intervention. However, the teachers or parents are also welcomed to attend.

b) Printed brochures on head lice management and prevention for each student to be brought home.
The printed materials will also be made available on the school notice board and Health Room.

c) Focus Group Discussion on head lice management and prevention for students with head lice at the time of inspection.
Each session is allocated for each school in the intervention group. Each session will last for approximately 2 hours. The students will be assessed on their knowledge, attitude, and practices in the management and prevention of head lice. They will be encouraged to share their difficulty, concern, and challenges in dealing with head lice infestation. Appropriate advice will be given accordingly.

Intervention code [1]

Prevention

Intervention code [2]

Treatment: Other

Comparator / control treatment

The control group will be waitlisted and received the similar health intervention module received by the intervention group when the study period is completed (i.e waitlist control group will be offered the intervention after 6 weeks from the first visit by the researcher).

Control group

Active

Outcomes

Primary outcome [1]

Knowledge about Pediculosis capitis infestation assessed by the knowledge section of the questionnaire.

The questionnaires that will be used has been designed specifically for this study.

Timepoint [1]

at baseline and two weeks after intervention

Primary outcome [2]

Attitude towards Pediculosis capitis infestation assessed by the attitude section of the questionnaire.

The questionnaire has been designed specifically for this study.

Timepoint [2]

at baseline and two weeks after intervention

Primary outcome [3]

Practices towards Pediculosis capitis infestation assessed by the practices section of the questionnaire.

The questionnaire has been designed specifically for this study.

Timepoint [3]

At baseline and two weeks after intervention

Secondary outcome [1]

Re-infestation rate of Pediculosis capitis after successful eradication
This is determined by the level of re-infestation with Pediculosis capitis measured at six weeks after successful eradication among the respondents.
The desired outcome was the elimination of head lice using two applications of treatment, seven days apart. All participants were examined by dry detection combing, six weeks after successful eradication to check for the presence of lice or eggs. It was determined using the following formula:
Re-infestation of Pediculosis capitis (N%)
= Number of students re-infested at 6-weeks after successful eradication x 100
-----------------------------------------------------------
Number of students had successful eradication 2 weeks after applying pediculicides

Timepoint [1]

six weeks after successful eradication of head lice among the respondents.

Secondary outcome [2]

Prevalence of Pediculosis capitis.

All participants were examined by visual inspection using dry combing method, to check for the presence of lice or eggs. It was determined using the following formula:
Prevalence of Pediculosis capitis (N%)
= Number of students infested x 100
-------------------------------------------
Number of students screened at baseline

(Note : This is the fourth primary outcome)

Timepoint [2]

At baseline

Eligibility

Key inclusion criteria

1. All standard four and five students in the selected government primary schools in Hulu Langat district with Pediculosis capitis infestation.
2. Consented by the parents or caregivers and the students to participate in this study.
3. The student was available throughout the whole duration of data collection.

Minimum age

10 Years

Maximum age

12 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

1. The students who were attending special education classes.
2. Participation in another clinical study within one month before entry to this study.
3. Usage of any pediculicide at the time of data collection or for the whole or partial duration of one month prior to the data collection.
4. Active scalp infection or scalp lesions such as psoariasis or eczema.
5. Allergic to any ingredient of the pediculicide based on the information provided by the parents.

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

The allocation of the schools into intervention and control group is carried out by an independent statistician who does not involve in this study.
All the schools were assigned a number starting from one to 87. An online random number generator was used (http://stattrek.com/statistics/random-number-generator.aspx). The ten numbers generated were matched with the number assigned to each school. The first five schools identified from the random number generator are classified as intervention group, and the remaining five schools are in the control group.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software for computerised sequence generation.
(http://stattrek.com/statistics/random-number-generator.aspx)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Data analysis was done by using Statistical Package for Social Sciences version 22 (SPSS Inc, Chicago, IL, USA). After all the data were entered, data cleaning was carried out to identify any error during data entry. Descriptive statistics was carried out to determine the socio-demographic distribution of respondents between the intervention and control groups. The description was given in frequency and percentage.

Socio-demographic characteristics for both groups were compared using chi-square test or fisher exact’s test to determine the association of respondents of both groups. The prevalence of Pediculosis capitis was given in frequency and percentage. For 2x2 table that contained cell with expected count less than 5, Fischer’s Exact test was used to determine the association between the groups. To assess changes from baseline to post-intervention, Paired t-test or Wilcoxon signed-rank test was applied for continuous data.

Descriptive statistical analysis was used to provide information about respondents’ knowledge, attitude and practices. Considering normal distribution of knowledge and attitude subscales as dependent variables, mean and standard deviations were computed for each subscale of knowledge and attitude.

To determine the significant factors which determine the absence or presence of Pediculosis capitis, multiple logistic regression was used. Continuous independent variables such as knowledge, attitude and practices subscales were entered as predictor factors in a logistic regression model.

Mc Nemar’s test was conducted as the same individuals were measured thrice (baseline, immediate and 6-weeks after the intervention) to evaluate the impact of an education programme on three recurrent themes of Pediculosis capitis between baseline and post-intervention: 1) Knowledge 2) Attitude 3) Practices.

A Multi-Level Modelling (Generalised Linear Mixed Model) analysis was employed to look at the main and interaction effects within and between groups for all the continuous & categorical dependant variables. This is to ensure that all possible contextual variables of different levels were considered in the analysis. This was done to ensure that the clustering effect is considered during the analysis to come to the most accurate inferential statistical results.

Due to the complexity of this study where multiple continuous and categorical dependent variables was measured repeatedly at two different time with possible large variation in the distribution of mean scores across a huge sample size of thousands of study subjects, a more complex analysis in the form of Generalized Liner Mixed Model is required. The analysis is also able to control and adjust for the clustering effect of the schools and treatment groups by identifying and classifying both as the contextual variables during the analysis to yield a more accurate result. In principle, generalized linear mixed model extends the linear model so that:
i. The target is linearly related to the factors and covariates via a specified link function.
ii. The target can have a non-normal distribution.
iii. The observations can be correlated.

Generalized linear mixed models cover a wide variety of models, from simple linear regression to complex multilevel models for non-normal longitudinal data, making it the most suitable type of analysis for this study. Generalized Linear Mixed model includes both the fixed effects and random intercepts in the model. Treatment group (intervention or control) and individual study subjects was included as the Contextual Variables and adjusted accordingly in the analysis. Main Dependent Variable in this study is the mean knowledge score for baseline and after the intervention while secondary dependent variables are the prevalence of Pediculosis capitis before and after the usage of pediculicide. The final model was decided based on effect of entering and removing independent variables and covariates into the model on the Akaike Corrected & Bayesian index. Models with smaller information criterion values fits better.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

7/08/2017

Date of last participant enrolment

Anticipated

Actual

29/08/2017

Date of last data collection

Anticipated

Actual

13/10/2017

Sample size

Target

300

Accrual to date

Final

297

Recruitment outside Australia

Country [1]

Malaysia

State/province [1]

Selangor

Funding & Sponsors

Funding source category [1]

University

Name [1]

UNIVERSITI PUTRA MALAYSIA

Address [1]

Universiti Putra Malaysia, Jalan UPM, 43400 Serdang, Selangor, Malaysia

Country [1]

Malaysia

Primary sponsor type

University

Name

UNIVERSITI PUTRA MALAYSIA

Address

Universiti Putra Malaysia, Jalan UPM, 43400 Serdang, Selangor, Malaysia

Country

Malaysia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

UNIVERSITI PUTRA MALAYSIA ETHICS COMMITTEE

Ethics committee address [1]

Jalan Upm, 43400 Serdang, Selangor, Malaysia

Ethics committee country [1]

Malaysia

Date submitted for ethics approval [1]

14/09/2016

Approval date [1]

16/01/2017

Ethics approval number [1]

FPSK(EXP16)P163

Summary

Brief summary

Pediculosis capitis is a common condition caused by the infestation of the hair and scalp by Pediculus humanus capitis (head louse). Head-lice infestation is most frequent in children aged 3–10, that is the primary school age children and their families. Approximately 3% of school children in the United States contract head lice. In Malaysia, a study by Bachok N. done in 2004 among primary school children in Kelantan showed that the prevalence of head lice infestation was 35.0%. 
Even though head lice infestation does not cause significant health problems, it can cause other physical, psychological and economic impacts. For instance, head lice can cause scalp itchiness leading to disturbed sleep. The children who have impaired and insufficient sleep at night might have difficulty to concentrate in the classrooms. Intense itching might cause injury to the scalp leading to bacterial infection. They might also feel embarrassed and have reduced self-esteem whenever their friends know about them having head lice infestation. The children might have been teased for not being hygienic even though poor hygiene is not the cause of head lice infestation. Psychological impact can also be seen among the caretakers due to frustration in managing recurrent head lice infestation. The treatment of head lice may require several visits to the primary care centers or direct buying of the head lice shampoo from the pharmacy. The cost involved in treating head lice might cause significant economic impact to the family. 
There are many factors associated with the occurrence of pediculosis capitis. Some of the socio-demographic factors identified are the age, gender, household income and level of parent’s education. On the other hand, there are several individual characteristics that contribute to the occurrence of pediculosis capitis such as hygiene practice, hair length and hair type. Direct head-to-head contact is the main factor of transmission. This can be caused by sharing head gears (caps, tudung), hair brush, pillows or towels. It can also be caused by closeness in physical contact when the children play together, or in a crowded house or classrooms.  
Pediculicides are substances used to treat head lice. There are many pediculicides being sold in the pharmacy and easily accessible for the treatment of head lice. However, re-infestation may still occur if the children are still exposed to the risk factors of head lice infestation such as sharing comb and being in close distance with other people who are infested with head lice.  Therefore, it is important to provide health education for the students and family members so that the risk of infestation and re-infestation can be lowered.  
The study is conducted to determine the number of primary school students in Hulu Langat district who are infested with head lice and to identify the risk factors. This research is also to study the effectiveness of health education in the management of head lice.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Nor Faiza Mohd. Tohit

Address

Dept. of Community Medicine
Faculty of Medicines and Health Sciences
Universiti Putra Malaysia
43400 UPM Serdang
Selangor Darul Ehsan

Country

Malaysia

Phone

+60389472606

Fax

faizatohit@outlook.com

Contact person for public queries

Name

Nor Faiza Mohd. Tohit

Address

Dept. of Community Medicine
Faculty of Medicines and Health Sciences
Universiti Putra Malaysia
43400 UPM Serdang
Selangor Darul Ehsan

Country

Malaysia

Phone

+60389472606

Fax

faizatohit@outlook.com

Contact person for scientific queries

Name

Dr. Lekhraj Rampal

Address

Dept. of Community Medicine
Faculty of Medicines and Health Sciences
Universiti Putra Malaysia
43400 UPM Serdang
Selangor Darul Ehsan

Country

Malaysia

Phone

+6038947 2411

Fax

lekhraj@upm.edu.my

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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