Comfort Talk for Pediatric Cardiac Catheterization

NCT ID: NCT02347748

Last Updated: 2019-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2018-09-30

Brief 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.

Detailed Description

Among scheduled children for cardiac catheterization at the Labatt Family Health Center Cardiac Diagnostic and Interventional Unit (CDIU) , potential participants will be identified at their pre-catheterization clinic visit, the study explained, and informed consent obtained. On the day of their procedure, participants will be randomized to one of 4 groups. In the pre-catheterization work-up area, a modified Yale Preoperative Anxiety Scale (mYPAS) plus anxiety and pain self-ratings on verbal 0-10 scales will be obtained. In intervention groups A and C a pre-procedure Comfort Talk script will be read while the parent or guardian is present. Patients in Group B and D will not have a script read. The participants will be reassessed by mYPAS and asked to rate their level of pain and anxiety again on entering the procedure room and then care will continue as usual. The team members and anaesthesiologist will be blinded to the prior treatment and behave naturally but abstain from formalized use of hypnosis, invitation to imagery, use of scripts or electronic means of distraction. Induction of anaesthesia and the procedure will continue according to laboratory routine. Use of premedication will be permitted as per judgement of the anaesthesiologist. After induction a Paediatric Anesthesia Behaviour score (PAB) rating will be obtained. Prior to extubation, one of the CDIU nurses will read the pre-extubation script for those subjects in Groups B and C. Extubation and transfer to recovery will follow usual routine.

When the patients are transferred to the recovery room nurses will be unaware of group attribution. On waking from anaesthesia and up to 6 hours post-operatively, participants will again be asked to rate their levels of pain and anxiety at various intervals.

Within 24-48 hours of discharge from the hospital, families will be called to follow-up on their experience in the CDIU using the follow-up questionnaire regularly used by the CDIU nurses. At the same time the parents will be reminded to fill in the Post Hospitalization Behaviour Questionnaire (PHBQ) reflecting the child's behaviour in the first week after the procedure and mail it back in the stamped addressed envelope provided. If the envelope has not been mailed back within 10 days one of the research team members will call and complete it with the parents over the phone.

The pre-procedure script is based on a script that three large prospective randomized trials found to be effective in adults in reducing anxiety, pain, and complications of invasive image-guided procedures. It has been modified for use in paediatrics. The standardized script containing relaxing and hypnoidal language with suggestions for coping strategies will be read by CDIU RNs trained in Comfort Talk in the pre-catheterization work-up area. The pre-extubation script contains suggestions for healing, recovery, functioning of bodily systems, and acknowledgement of the patient's contribution.

Conditions

Anxiety; Pain; Adaptation, Psychological; Stress, Psychological

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Group A - Reading pre-procedure script

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

Group Type: EXPERIMENTAL

Reading pre-procedure script

Intervention Type: BEHAVIORAL

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

Group B - Reading pre-extubation script

Patients will be read a pre-extubation script;

Group Type: EXPERIMENTAL

Reading pre-extubation script

Intervention Type: BEHAVIORAL

Patients will be read a comfort talk script before extubation

Group C - 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 pre-extubation script

Group Type: EXPERIMENTAL

Reading pre-procedure script

Intervention Type: BEHAVIORAL

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

Reading pre-extubation script

Intervention Type: BEHAVIORAL

Patients will be read a comfort talk script before extubation

Reading 2 scripts

Intervention Type: BEHAVIORAL

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

Group D

Patients will not be read any script

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Reading pre-procedure script

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

Intervention Type: BEHAVIORAL

Reading pre-extubation script

Patients will be read a comfort talk script before extubation

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Scheduled for cardiac catheterization
• Procedure performed under general anesthetic
• Ability to speak and understand English
• No apparent cognitive impairments

Exclusion Criteria

• Active dissociative psychiatric disease

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Jacqueline Viegas

RN

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jacquie Viegas, RN

Role: PRINCIPAL_INVESTIGATOR

Hospital for Sick Childen, Toronto, CA

Locations

Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

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Other Identifiers

1000046792

Identifier Type: -

Identifier Source: org_study_id