Changes in behaviour of children after day-care surgery

Not yet recruiting

• Conditions: Problems related to medical facilities and other health care,

• Registration Number: CTRI/2020/05/025461
• Lead Sponsor: Department of Anaesthesia and Intensive Care

Brief Summary

Background - Hospitalisation, particularly surgery is a major cause of stress for children. It may impact his/her psychological and social development or may affect the response to subsequent medical care in the future.

Aim of study - To assess the incidence and pattern of behavioural changes in children undergoing ambulatory surgery and to identify the risk factors associated with post-operative behavioural changes.

Primary objective - To quantify the incidence of behavioural changes on post-operative day 1, 7 and 14 using post hospitalisation behavioural questionnaire (PBHQ-AS).

Secondary objective - To identify risk factors associated with post operative behavioural changes.

Materials and methods - A prospective cohort observational study will be conducted in Paediatric OT, Advanced Paediatric Centre, PGIMER, Chandigarh. Demographic characteristics, child’s and parents education, socio-economic status of family, child’s temperament (EASI scale), pre-operative anxiety (mYPAS scale), induction compliance checklist (ICC) prior to anaesthesia, emergence delirium (PAED scale) will be recorded which have been considered risk factors in previous studies. Following surgery the parents will be interviews via phone call on post-operative day 1, 7 and 14 to assess the child’s post-operative pain measure (PPPM scale) and post-operative behaviour (PHBQ-AS).

Analysis - Based on the above mentioned characteristics the study will aim to assess the incidence and risk factors related to behaviour changes on Indian children and the impact it has on the future outcome related to hospitalisation and surgery. This will be helpful in guiding us towards improvements in our approach toward paediatric population who are taken up for surgical procedures in the future.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-06
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 217

Inclusion Criteria

Children belonging to ASA I and II Children with English and/or Hindi speaking parents Children posted for ambulatory/ day care study.

Exclusion Criteria

Children with developmental delay or neurocognitive disorders.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the incidence of behavioural changes on postoperative day 1, 7 and 14 using post-hospitalisation behavioural questionnaire - ambulatory surgery (PHBQ-AS)	1, 7 and 14 days

Secondary Outcome Measures

Name	Time	Method
To identify risk factors associated with post-operative behavioural changes	1, 7 and 14 days

Trial Locations

Locations (1)

Postgraduate Institute of Medical Education and Research, PGIMER; 🇮🇳 Chandigarh, CHANDIGARH, India

Postgraduate Institute of Medical Education and Research, PGIMER

🇮🇳Chandigarh, CHANDIGARH, India

Dr Sandhya Yaddanapudi

Principal investigator

9872005576

sandhya.yaddanapudi@gmail.com