Clinical trial NCT02347748: Comfort Talk for Pediatric Cardiac Catheterization
Official title: The Impact of Comfort Talk on Anxiety Levels and Procedural Experience in a Pediatric Population Undergoing Cardiac Catheterization: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Pain
Adaptation, Psychological
Stress, Psychological
Keywords: Pain
Anesthesia Recovery Period
Postoperative Period
Adaptation, Psychological
Relaxation
Stress, Psychological
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2015-01-27
Enrollment: 160
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Pre-anesthesia Anxiety
timeFrame: 3-15 min prior to anesthesia induction
measure: Postoperative Behavior
timeFrame: 1 week postoperatively
Secondary outcomes:
measure: Satisfaction with care
timeFrame: 24-48 hrs after discharge from the hospital
measure: Procedure Time
timeFrame: Duration of the cardiac catheterization procedure (1-4 hrs depending on complexity of case)
measure: Recovery room time
timeFrame: within 24 hrs of procedure
measure: Drug usage during procedure
timeFrame: 1-4 hrs
measure: Drug usage during recovery
timeFrame: within 24 hrs
measure: Antiemetics
timeFrame: within 28 hrs
measure: Anesthesia induction behavior
timeFrame: within1 hr of anesthesia induction
measure: Nausea
timeFrame: within 28 hrs of procedure start
measure: Rebleeds
timeFrame: within 1 week of procedure
measure: any pain
timeFrame: within 28 hrs of arrival
measure: Self-reported anxiety
timeFrame: within 28 hrs of arrival
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Hospital for Sick Childen, Toronto, CA
name: Jacquie Viegas, RN
role: PRINCIPAL_INVESTIGATOR
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