Comfort Talk for Pediatric Cardiac Catheterization

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02347748
• Other study ID #: 1000046792
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: September 2018

Study information

• Verified date: July 2019
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: September 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adaptation, Psychological
• Anxiety
• Pain
• Stress, Psychological

Intervention

Behavioral:
• Reading pre-procedure script
Patients will be read a pre-procedure comfort talk script in the pre-procedure work-up area
• Reading pre-extubation script
Patients will be read a comfort talk script before extubation
• 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

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

References & Publications (20)

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. — View Citation

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. — View Citation

Butler LD, Symons BK, Henderson SL, Shortliffe LD, Spiegel D. Hypnosis reduces distress and duration of an invasive medical procedure for children. Pediatrics. 2005 Jan;115(1):e77-85. — View Citation

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. — View Citation

Davidson AJ. Awareness, dreaming and unconscious memory formation during anaesthesia in children. Best Pract Res Clin Anaesthesiol. 2007 Sep;21(3):415-29. — View Citation

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

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. Review. — View Citation

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. — View Citation

Kain ZN, Wang SM, Mayes LC, Caramico LA, Hofstadter MB. Distress during the induction of anesthesia and postoperative behavioral outcomes. Anesth Analg. 1999 May;88(5):1042-7. — View Citation

Karling M, Stenlund H, Hägglöf 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. — View Citation

Karling M, Stenlund H, Hägglöf B. Child behaviour after anaesthesia: associated risk factors. Acta Paediatr. 2007 May;96(5):740-7. — View Citation

Lang EV, Benotsch EG, Fick LJ, Lutgendorf S, Berbaum ML, Berbaum KS, Logan H, Spiegel D. Adjunctive non-pharmacological analgesia for invasive medical procedures: a randomised trial. Lancet. 2000 Apr 29;355(9214):1486-90. — View Citation

Lang EV, Berbaum KS, Faintuch S, Hatsiopoulou O, Halsey N, Li X, Berbaum ML, Laser E, Baum J. Adjunctive self-hypnotic relaxation for outpatient medical procedures: a prospective randomized trial with women undergoing large core breast biopsy. Pain. 2006 Dec 15;126(1-3):155-64. Epub 2006 Sep 7. — View Citation

Lang EV, Berbaum KS, Pauker SG, Faintuch S, Salazar GM, Lutgendorf S, Laser E, Logan H, Spiegel D. Beneficial effects of hypnosis and adverse effects of empathic attention during percutaneous tumor treatment: when being nice does not suffice. J Vasc Interv Radiol. 2008 Jun;19(6):897-905. doi: 10.1016/j.jvir.2008.01.027. Epub 2008 Mar 17. — View Citation

Lang EV, Rosen MP. Cost analysis of adjunct hypnosis with sedation during outpatient interventional radiologic procedures. Radiology. 2002 Feb;222(2):375-82. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Watson AT, Visram A. Children's preoperative anxiety and postoperative behaviour. Paediatr Anaesth. 2003 Mar;13(3):188-204. Review. — View Citation

Yip P, Middleton P, Cyna AM, Carlyle AV. Non-pharmacological interventions for assisting the induction of anaesthesia in children. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD006447. doi: 10.1002/14651858.CD006447.pub2. Review. Update in: Cochrane Database Syst Rev. 2015;7:CD006447. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Postoperative Behavior	Measured with the Post Hospitalization Behaviour Questionnaire (PHBQ)	1 week postoperatively
Secondary	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
Secondary	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)
Secondary	Recovery room time	Measure per recovery room log	within 24 hrs of procedure
Secondary	Drug usage during procedure	Amount of anesthesia drugs given in drug units	1-4 hrs
Secondary	Drug usage during recovery	Amount of sedatives and narcotics in drug units	within 24 hrs
Secondary	Antiemetics	Amount of antiememtics in drug units	within 28 hrs
Secondary	Anesthesia induction behavior	Measured by the Pediatric Anesthesia Behaviour Score (PAB)	within1 hr of anesthesia induction
Secondary	Nausea	measured by frequency and severity	within 28 hrs of procedure start
Secondary	Rebleeds	counts and severy	within 1 week of procedure
Secondary	any pain	0-10 self-reporting scale	within 28 hrs of arrival
Secondary	Self-reported anxiety	0-10 self-reporting scale	within 28 hrs of arrival