Comfort Talk for Pediatric Cardiac Catheterization
Condition: Anxiety; Pain; Adaptation, Psychological; Stress, Psychological
MeSH terms: Stress, Psychological
Study type: Interventional

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.
    

Intervention name(s): Reading pre-procedure script; Reading pre-extubation script; Reading 2 scripts
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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; 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Pain; Anesthesia Recovery Period; Postoperative Period; Adaptation, Psychological; Relaxation; Stress, Psychological