Comfort Talk for Pediatric Cardiac Catheterization

NCT02347748 | Completed DMC

• 1 other identifier: 1000046792
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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. 1.Patients being read a preoperative Comfort Talk script will experience less anxiety prior to anaesthesia induction.
2. 2.The reduction of anxiety prior to induction is associated with better immediate and short-term recovery outcomes.
3. 3.Patients being read a pre-extubation script will recover better than controls.
4. 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.

Conditions

Anxiety; Pain; Adaptation, Psychological; Stress, Psychological

Keywords

Pain; Anesthesia Recovery Period; Postoperative Period; Adaptation, Psychological; Relaxation; Stress, Psychological

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (11)

• Satisfaction with care

  24-48 hrs after discharge from the hospital

• Procedure Time

  Duration of the cardiac catheterization procedure (1-4 hrs depending on complexity of case)

• Recovery room time

  within 24 hrs of procedure

• Drug usage during procedure

  1-4 hrs

• Drug usage during recovery

  within 24 hrs

Study Arms (4)

Group A - Reading pre-procedure script

EXPERIMENTAL

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

Behavioral: Reading pre-procedure script

Group B - Reading pre-extubation script

EXPERIMENTAL

Patients will be read a pre-extubation script;

Behavioral: Reading pre-extubation script

Group C - Reading 2 scripts

EXPERIMENTAL

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; Behavioral: Reading pre-extubation script; Behavioral: Reading 2 scripts

Group D

NO INTERVENTION

Patients will not be read any script

Interventions

Reading pre-procedure script BEHAVIORAL

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

Group A - Reading pre-procedure script; Group C - Reading 2 scripts

Reading pre-extubation script BEHAVIORAL

Patients will be read a comfort talk script before extubation

Group B - Reading pre-extubation script; Group C - Reading 2 scripts

Reading 2 scripts 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 C - Reading 2 scripts

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Active dissociative psychiatric disease

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (21)

• Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. doi: 10.1097/00000539-199710000-00012.

  PMID: 9322455 BACKGROUND

• Varughese AM, Nick TG, Gunter J, Wang Y, Kurth CD. Factors predictive of poor behavioral compliance during inhaled induction in children. Anesth Analg. 2008 Aug;107(2):413-21. doi: 10.1213/ane.0b013e31817e616b.

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• Karling M, Stenlund H, Hagglof B. Child behaviour after anaesthesia: associated risk factors. Acta Paediatr. 2007 May;96(5):740-7. doi: 10.1111/j.1651-2227.2007.00258.x.

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  PMID: 11818602 BACKGROUND

• Montgomery GH, David D, Winkel G, Silverstein JH, Bovbjerg DH. The effectiveness of adjunctive hypnosis with surgical patients: a meta-analysis. Anesth Analg. 2002 Jun;94(6):1639-45, table of contents. doi: 10.1097/00000539-200206000-00052.

  PMID: 12032044 BACKGROUND

• Faymonville ME, Meurisse M, Fissette J. Hypnosedation: a valuable alternative to traditional anaesthetic techniques. Acta Chir Belg. 1999 Aug;99(4):141-6.

  PMID: 10499382 BACKGROUND

• Flory N, Lang E. Practical hypnotic interventions during invasive cancer diagnosis and treatment. Hematol Oncol Clin North Am. 2008 Aug;22(4):709-25, ix. doi: 10.1016/j.hoc.2008.04.008.

  PMID: 18638697 BACKGROUND

• Davidson AJ. Awareness, dreaming and unconscious memory formation during anaesthesia in children. Best Pract Res Clin Anaesthesiol. 2007 Sep;21(3):415-29. doi: 10.1016/j.bpa.2007.05.001.

  PMID: 17900018 BACKGROUND

• Crandall M, Lammers C, Senders C, Savedra M, Braun JV. Initial validation of a numeric zero to ten scale to measure children's state anxiety. Anesth Analg. 2007 Nov;105(5):1250-3, table of contents. doi: 10.1213/01.ane.0000284700.59088.8b.

  PMID: 17959951 BACKGROUND

• Bringuier S, Dadure C, Raux O, Dubois A, Picot MC, Capdevila X. The perioperative validity of the visual analog anxiety scale in children: a discriminant and useful instrument in routine clinical practice to optimize postoperative pain management. Anesth Analg. 2009 Sep;109(3):737-44. doi: 10.1213/ane.0b013e3181af00e4.

  PMID: 19690240 BACKGROUND

• Vernon DT, Schulman JL, Foley JM. Changes in children's behavior after hospitalization. Some dimensions of response and their correlates. Am J Dis Child. 1966 Jun;111(6):581-93. doi: 10.1001/archpedi.1966.02090090053003. No abstract available.

  PMID: 5939538 BACKGROUND

• Karling M, Stenlund H, Hagglof B. Behavioural changes after anaesthesia: validity and liability of the Post Hospitalization Behavior Questionnaire in a Swedish paediatric population. Acta Paediatr. 2006 Mar;95(3):340-6. doi: 10.1080/08035250500434751.

  PMID: 16497646 BACKGROUND

• Beringer RM, Greenwood R, Kilpatrick N. Development and validation of the Pediatric Anesthesia Behavior score--an objective measure of behavior during induction of anesthesia. Paediatr Anaesth. 2014 Feb;24(2):196-200. doi: 10.1111/pan.12259. Epub 2013 Sep 19.

  PMID: 24103068 BACKGROUND

• Viegas J, Holtby H, Runeckles K, Lang EV. The Impact of Scripted Self-Hypnotic Relaxation on the Periprocedural Experience and Anesthesiologist Sedation Use in the Pediatric Cardiac Catheterization Suite: A Prospective Randomized Controlled Trial. J Pain Res. 2022 Oct 27;15:3447-3458. doi: 10.2147/JPR.S373608. eCollection 2022.

  PMID: 36324867 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Pain; Stress, Psychological

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Jacquie Viegas, RN

  Hospital for Sick Childen, Toronto, CA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN

Study Record Dates

• First Submitted: January 21, 2015
• First Posted: January 27, 2015
• Study Start: January 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: September 1, 2018
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

CA (1)