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临床试验/CTRI/2024/05/067924
CTRI/2024/05/067924尚未招募不适用

A cross-sectional study on knowledge, attitude and practice of parents of children with cerebral palsy

未提供1 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2024年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
133
试验地点
1
主要终点
1.To assess knowledge of parents of children with cerebral palsy

研究概览

简要总结

Aims and Objectives:

primary objective

  1. To assess the knowledge of parents of children with cerebral palsy.
  2. To determine the attitude of parents of children with cerebral palsy.

Secondary objective To assess the practices of parents of children with cerebral palsy.

Materials and Methods:

**Ethics:**The study will be initiated after seeking approval from the “Institutional Ethics Committee (IEC)”. The study will be conducted in compliance with the “Ethical Guidelines for Biomedical Research on Human Participants” by the Indian Council of Medical Research.

Consent: Case enrolment will be done after a written informed consent is obtained from the parents of patients.

**Study Design:**A single Centre, cross-sectional study comprising data collected prospectively over one year.

**Study site:**The study will be conducted in patients attending Pediatric General and Epilepsy OPD and admitted in wards.

Confidentiality: The participant’s details will not be disclosed at any point of time. Also, during publication of the data, all care will be taken to not disclose the details of the individual participants/subjects.

Study Population: Parents of children aged between 1- 12 years with cerebral palsy.

**Study duration:**The study will be conducted for a period of 18 months (after approval from IEC).

Inclusion Criteria:

1.     Parents of children aged between 1-12 years.

2.     Children diagnosed with cerebral palsy.

**Exclusion Criteria:**Parents who have not given consent to participate in the study.

**Sample size calculation:**Purposive sampling is done for the given study. Parents of children with cerebral palsy visiting Pediatric General and Epilepsy outpatient department (OPD) admitted in wards during the study period. Based on inclusion and exclusion criteria will be included in the study. Based on previous 3 years data approximately 7-8 cerebral palsy patients including indoor and outdoor patients visit hospital each month. By the given data if we consider 8 patients per month, in 15 months there will be approximately 133 cerebral palsy patients. sample size for the study is 133 participants, accounting for 10% attrition rate.

Study Procedure:

Diagnosed cases of cerebral palsy visiting Pediatric General and Epilepsy OPD and admitted in wards will be enrolled in the study as per the inclusion criteria

Those who fulfil the criteria, written informed consent will be obtained from their parents/guardian.

Once consent has been obtained, ICD (informed consent document) will be signed. One copy will be retained by the principal investigator and a copy of ICD will be given to patient’s parents. Each patient will be assigned a unique study identification number.

Data will be collected in a case record form by the interviewer herself.

**Study tool:**A structured questionnaire is developed to collect the data. Which is validated by the team of experts. The questionnaire consists of following parts.

**Part A:**Case Record Performa to record socio demographic variables of the child and parents.

**Part B:**structured questionnaire which consist of following parts.

**i.**To assess knowledge of parents regarding cerebral palsy.

**ii.**To measure the level of attitude, four-point Linkert scale is used. Each response will be noted as positive or negative attitude.

**iii.**Observational checklist of practice of parents.

Statistical Analysis:

Descriptive statistics will be described in counts/percentages for categorical variables.

Numerical variables like demographic and clinical profile will be expressed as mean+- standard deviation (SD).

Outcome will be assessed by using chi-square test.

P<0.05 as significant.

The data will be analyzed using the statistical package for social sciences (SPSS) Version 25.0

  |Vancouver style Referencing

1.    K. Vitrikas, H. Dalton, and D. Breish, Cerebral palsy: an overview.American Family Physician*.*2020;101(4):213-220.

2.    Mac Keith RC, Mackenzie I, Polani P. The Little Club. Memorandum on terminology and classification of cerebral palsy. Dev Med Child Neurol*.*1959; 1:27-35. Doi: 10.1111/j. 1469-8749. 1959.tb08073.x

3.    Bax M. Terminology and classification of cerebral palsy. Dev Med Child Neurol*.*1964; 6:295-297.

4.    Bax M, Goldstein M, Rosenbaum P, et al. Executive Committee for the Definition of cerebral palsy. Proposed definition and classification of cerebral palsy. Dev Med Child Neurol.2005;47(8):571-576. doi:10.1017/S001216220500112X

5.    Rosenbaum P, Paneth N, Leviton A, et al. A report: the definition and classification of cerebral palsy. Dev Med Child Neurol*.*2007; 109:814.

6.    Cans C, Dolk H, Platt MJ, Clover A, Prasaukiene A, Krageloh-Mann I; SCPE collaborative group. Recommendations from the SCPE collaborative group for defining and classifying cerebral palsy. Dev

Med Child Neurol Supp*.* 2007; 109:35-38. doi: 10.1111/j.14698749. 2007.tb12626.x

7.    Arneson CL, Durkin MS, Benedict RE, et al. Prevalence of cerebral palsy: autism and developmental disabilities monitoring network, three sites, United states, 2004. Diabil Health*J.*2009; 2:45-8.

8.    Bhasin T, Brocksen S, Avchen RN, Van Naarden Braun K. Prevalence of four developmental disabilities among children aged 8 yearsMetropolitan disabilities Surveillance Program, 1996 and 2000. MMWR Surveill Sumn.2006;55:1-9.

9.    Paneth N, Hong T, Korzeniewksi S. The descriptive epidemiology of cerebral palsy. Clin Perinatol. 2006; 33:251-67.

10.Winter S, Autry A, Boyle C, Yeargin-Allsopp M. Trends in the prevalence of cerebral palsy in a population-based study. Pediatrics. 2002; 110:1220-5.

11.Chauhan A, Singh M, Agarwal A, Sahu JK, Singh M. Prevalence of cerebral palsy in Indian children: a systematic review and metanalysis. Indian J Pediatr*.*2019;86(12):1124-1130.

12.Eicher PS, Batshaw ML. Cerebral palsy. Pediatr Clin North Am*.*1993; 40: 537-551.

13.Rosenbaum P. Cerebral palsy: what parents and doctors want to know. BMJ 2003; 326: 970-974.

14.Murphy N, Such-Neibar T. Cerebral palsy diagnosis and management: the state of art. Curr Probl Pediatr Adolesc Health Care. 2003;33: 146-169.

15.Novak I, Morgan C, Adde L, et al. Early, accurate diagnosis and early intervention in cerebral palsy: advances in diagnosis and treatment. JAMA Pediatr*.* 2017;171(9):897-907.

16.Ashwal S, Russman BS, Blasco PA, et al. Practice parameter: diagnostic assessment of the child with cerebral palsy: report of the quality standards subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology.2004;62(6):851-863.

17.Karande S, Patil S, and Kulkarni M.Impact of an educational program on parental knowledge of cerebral palsy. Indian journal of Pediatrics, 2008;75(9):901-906.

18.World Health Organization, Promoting the Development of Young Children with Cerebral Palsy*,*1993, http://whqlibdoc.who.int/hq/1993/WHO_RHB_93.1.pdf.

19.Amiri A, Kalantari M, Rezaee M, Akbarzadeh Baghan A Ghareshloo F. Effect of Child Factors on Parental Attitude Towards Children and Adolescents with Cerebral Palsy in Iran. Iranian Rehabilitation Journal. 2019;17(4):319-330.

20.Kaliyaperumal K. Guideline for Conducting Knowledge, Attitude and Practice (KAP) Study. Community Ophthalmology, 2004;4(1): 7-9.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Parents of children aged between 1 to 12 years diagnosed with cerebral palsy.

排除标准

  • Parents who have not given consent to participate in the study
  • parents of children who are admitted in the PICU.

结局指标

主要结局

1.To assess knowledge of parents of children with cerebral palsy

时间窗: 8weeks

2.To determine the attitude of parents of children with cerebral palsy

时间窗: 8weeks

3.To assess the practices of parents of children with cerebral palsy

时间窗: 8weeks

次要结局

  • To find the association of knowledge, attitude, & practices with demographic variables(8weeks)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Rajwanti vaswani

Seth G. S. Medical College & KEM Hospital

研究点 (1)

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