Pediatric Cardiac Surgery Pre-operative Counselling Study

NCT01909583 | Completed

• 1 other identifier: H2013:117
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

We have developed a pre-operative educational / counselling booklet with the focus on informing parents / patients about the different stages before, during, and after cardiac surgery that they will encounter; both chronologically and emotionally. With this approach and study our objectives are: 1\. To provide anticipatory guidance for parents to decrease parental stress and improve parental experience and preparedness, thus involving the parent as a partner in caring for their child. We hypothesize that this additional tool will improve parental satisfaction in regards to being prepared for their child's heart surgery.

Conditions

Congenital Heart Disease

Keywords

congenital; surgery; peri-operative; counselling

Outcome Measures

Primary Outcomes (1)

• Family satisfaction and stress score

  At post-operative visit families will complete a study questionnaire evaluating their satisfaction of pre-operative preparation and their stress levels during the surgical period

  up to 6 weeks post-operatively

Secondary Outcomes (2)

• Percentage of families that would recommend the STAGES-booklet as routine pre-operative educational tool.

  1 day (At post-operative visit)

• Family Stress score during each stage as outlined in the STAGES-booklet

  1 day (At post-operative visit)

Study Arms (2)

STAGES PRE-GROUP

ACTIVE COMPARATOR

INTERVENTION: this group will receive our "STAGES" booklet PRE-operatively

Other: STAGES-Booklet

STAGES POST-GROUP

PLACEBO COMPARATOR

INTERVENTION: This arm will only receive the STAGES-booklet POST-operatively

Other: STAGES-Booklet

Interventions

STAGES-Booklet OTHER

STAGES-booklet was designed by the investigators focussing on guiding parents through the pre-operative and operative admission period.

STAGES POST-GROUP; STAGES PRE-GROUP

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \. All consented families of children \<18 years that will be sent out of province for cardiac surgery from the Variety Children's Heart Centre

You may not qualify if:

• \. Families that can't read or write english

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Variety Children's Heart Centre

Winnipeg, Manitoba, Canada

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• David Horne, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: July 24, 2013
• First Posted: July 26, 2013
• Study Start: June 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: June 14, 2016

Record last verified: 2016-06

Locations

CA (1)