Comfort Talk for Pediatric Cardiac Catheterization

Study Overview
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Brief Summary
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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: Patients being read a preoperative Comfort Talk script will experience less anxiety prior to anaesthesia induction. The reduction of anxiety prior to induction is associated with better immediate and short-term recovery outcomes. Patients being read a pre-extubation script will recover better than controls. 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
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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.

Official Title
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The Impact of Comfort Talk on Anxiety Levels and Procedural Experience in a Pediatric Population Undergoing Cardiac Catheterization: A Prospective Randomized Controlled Trial

Conditions
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Anxiety, Pain, Adaptation, Psychological, Stress, Psychological

Intervention / Treatment
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* Behavioral: Reading pre-procedure script
* Behavioral: Reading pre-extubation script
* Behavioral: Reading 2 scripts


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A - Reading pre-procedure script<br>Patients will be read a pre-procedure comfort talk script in the pre-procedure work-up area | Behavioral: Reading pre-procedure script<br>* Patients will be read a pre-procedure comfort talk script in the pre-procedure work-up area<br>|
| Experimental: Group B - Reading pre-extubation script<br>Patients will be read a pre-extubation script; | Behavioral: Reading pre-extubation script<br>* Patients will be read a comfort talk script before extubation<br>|
| Experimental: Group C - Reading 2 scripts<br>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 | Behavioral: Reading pre-procedure script<br>* Patients will be read a pre-procedure comfort talk script in the pre-procedure work-up area<br>Behavioral: Reading pre-extubation script<br>* Patients will be read a comfort talk script before extubation<br>Behavioral: Reading 2 scripts<br>* 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<br>|
| No Intervention: Group D<br>Patients will not be read any script | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre-anesthesia Anxiety | Anxiety is measured by the modified Yale Preoperative Anxiety Scale (mYPAS) immediately upon entry into the operating room and introduction of the anesthesia mask to the child. The mYPAS consists of 22 items in five categories (activity, emotional expressivity, state of arousal, vocalization, and use of parents) and a maximal score of 100. | 3-15 min prior to anesthesia induction | 
| Postoperative Behavior | Measured with the Post Hospitalization Behaviour Questionnaire (PHBQ) | 1 week postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with care | CDIU Post Cardiac Catherization follow-up phone survey addressing presence or absence of discomfort, bruising at the cath site, fever, return to normal bodily functions and activity, satisfaction with treatment from and communication with staff. | 24-48 hrs after discharge from the hospital | 
| Procedure Time | Duration of the cardiac catheterization procedure (1-4 hrs depending on complexity of case) | Duration of the cardiac catheterization procedure (1-4 hrs depending on complexity of case) | 
| Recovery room time | Measure per recovery room log | within 24 hrs of procedure | 
| Drug usage during procedure | Amount of anesthesia drugs given in drug units | 1-4 hrs | 
| Drug usage during recovery | Amount of sedatives and narcotics in drug units | within 24 hrs | 
| Antiemetics | Amount of antiememtics in drug units | within 28 hrs | 
| Anesthesia induction behavior | Measured by the Pediatric Anesthesia Behaviour Score (PAB) | within1 hr of anesthesia induction | 
| Nausea | measured by frequency and severity | within 28 hrs of procedure start | 
| Rebleeds | counts and severy | within 1 week of procedure | 
| any pain | 0-10 self-reporting scale | within 28 hrs of arrival | 
| Self-reported anxiety | 0-10 self-reporting scale | within 28 hrs of arrival | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Anesthesia Recovery Period, Postoperative Period, Adaptation, Psychological, Relaxation, Stress, Psychological