Comfort Talk for Pediatric Cardiac Catheterization

Summary

Background: Pre anaesthesia anxiety in children is a strong predictor of postoperative behavior challenges and outcomes. In addition, intra-operative stress can precipitate post-traumatic stress symptomatology. Comfort Talk, consisting of rapport, relaxation, and reframing of potentially stressful experiences, applied pre-operatively in script form, has been highly successful in alleviating anxiety and positively affecting procedural outcomes in adult patients undergoing interventional procedures. No published literature exists evaluating its' impact in paediatric cardiac catheterization. Purpose: To investigate the impact of comfort talk on the level of pre-induction anxiety, procedural and recovery experience, as well as short-term post-procedural behaviour and satisfaction after discharge in pediatric patients undergoing cardiac catheterization procedures. Design: Prospective randomized, double blind controlled trial. Participants: 160 children, ages 7-18 years, having a cardiac catheterization procedure under general anaesthesia. Intervention: Group A will be read a pre-procedure comfort talk script in the pre-procedure work-up area; Group B will be read a pre-extubation (before the breathing tube is removed) script ; Group C will be read a pre-procedure plus a pre-extubation script; Group D will not be read any script. All groups will be treated according to the standard of care approaches usually provided for anaesthesia, catheterization, and recovery. Outcomes: We will compare the effect of the script strategy on preoperative anxiety. Procedural and recovery measurements will include room time in the catheterization suite, time to discharge from the recovery room; drug use, vomiting, rebleeds, and cardiorespiratory stability. Postoperative behaviour will be assessed by questionnaire. Postoperative anxiety and pain will be secondary outcome measures using queries on 0-10 verbal self-report scales Hypotheses are:

1. Patients being read a preoperative Comfort Talk script will experience less anxiety prior to anaesthesia induction.
2. The reduction of anxiety prior to induction is associated with better immediate and short-term recovery outcomes.
3. Patients being read a pre-extubation script will recover better than controls.
4. The combination of a pre-procedure script and a pre-extubation script will have the greatest positive effect on physical and emotional well-being in the immediate recovery period and at short term follow-up.

Conditions

• Anxiety
• Pain
• Adaptation, Psychological
• Stress, Psychological

Interventions

BEHAVIORAL

Reading pre-procedure script

Patients will be read a pre-procedure comfort talk script in the pre-procedure work-up area

BEHAVIORAL

Reading pre-extubation script

Patients will be read a comfort talk script before extubation

BEHAVIORAL

Reading 2 scripts

Patients will be read a pre-procedure comfort talk script in the pre-procedure work-up area. Patients will be read a comfort talk script before extubation

Sponsors & Collaborators

• The Hospital for Sick Children

  lead OTHER

Principal Investigators

• Jacquie Viegas, RN · Hospital for Sick Childen, Toronto, CA

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2018-06-30

Completion

2018-09-30

Countries

• Canada

Study Locations