AnxietyNCT02347748
Comfort Talk for Pediatric Cardiac Catheterization
A study testing Reading pre-procedure script, Reading pre-extubation script and Reading 2 scripts in people with Anxiety and Pain, run by The Hospital for Sick Children at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Anxiety, Pain, Adaptation, Psychological
- What is being tested?
- Reading pre-procedure script, Reading pre-extubation script and Reading 2 scripts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Scheduled for cardiac catheterization
- Procedure performed under general anesthetic
- Ability to speak and understand English
- No apparent cognitive impairments
Who cannot join
- Active dissociative psychiatric disease
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Anxiety, Pain, Adaptation, Psychological, Stress, Psychological
- Being tested
- Reading pre-procedure script, Reading pre-extubation script, Reading 2 scripts
- Keywords
- Pain, Anesthesia Recovery Period, Postoperative Period, Adaptation, Psychological, Relaxation, Stress, Psychological
- Medical subject headings
- Anxiety Disorders, Pain, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reading pre-procedure scriptBehavioural
Patients will be read a pre-procedure comfort talk script in the pre-procedure work-up area
Reading pre-extubation scriptBehavioural
Patients will be read a comfort talk script before extubation
Reading 2 scriptsBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Group A - Reading pre-procedure script | Experimental | Patients will be read a pre-procedure comfort talk script in the pre-procedure work-up area Receives: Behavioral: Reading pre-procedure script |
| Group B - Reading pre-extubation script | Experimental | Patients will be read a pre-extubation script; Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-15 min prior to anesthesia induction
Postoperative Behavior
Measured with the Post Hospitalization Behaviour Questionnaire (PHBQ)
Measured: 1 week postoperatively
Secondary outcomes (11)
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.
Measured: 24-48 hrs after discharge from the hospital
Procedure Time
Duration of the cardiac catheterization procedure (1-4 hrs depending on complexity of case)
Measured: Duration of the cardiac catheterization procedure (1-4 hrs depending on complexity of case)
Recovery room time
Measure per recovery room log
Measured: within 24 hrs of procedure
Drug usage during procedure
Amount of anesthesia drugs given in drug units
Measured: 1-4 hrs
Drug usage during recovery
Amount of sedatives and narcotics in drug units
Measured: within 24 hrs
Antiemetics
Amount of antiememtics in drug units
Measured: within 28 hrs
Anesthesia induction behavior
Measured by the Pediatric Anesthesia Behaviour Score (PAB)
Measured: within1 hr of anesthesia induction
Nausea
measured by frequency and severity
Measured: within 28 hrs of procedure start
Rebleeds
counts and severy
Measured: within 1 week of procedure
any pain
0-10 self-reporting scale
Measured: within 28 hrs of arrival
Self-reported anxiety
0-10 self-reporting scale
Measured: within 28 hrs of arrival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacqueline Viegas, The Hospital for Sick Children
- Investigators
- Jacquie Viegas, RN, Principal investigator, Hospital for Sick Childen, Toronto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347748
- Sponsor's protocol ID
- 1000046792
- Status last verified
- Jul 2019
- First submitted
- 21 Jan 2015
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 9322455Varughese 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.
PubMed 18633018Yip 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.
PubMed 19588390Karling 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.
PubMed 17462064Kain 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. doi: 10.1097/00000539-199905000-00013.
PubMed 10320165Watson AT, Visram A. Children's preoperative anxiety and postoperative behaviour. Paediatr Anaesth. 2003 Mar;13(3):188-204. doi: 10.1046/j.1460-9592.2003.00848.x. No abstract available.
PubMed 12641680Lang 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. doi: 10.1016/S0140-6736(00)02162-0.
PubMed 10801169Lang 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. doi: 10.1016/j.pain.2006.06.035. Epub 2006 Sep 7.
PubMed 16959427Lang 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.
PubMed 18503905Butler 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. doi: 10.1542/peds.2004-0818.
PubMed 15629969Lang EV, Rosen MP. Cost analysis of adjunct hypnosis with sedation during outpatient interventional radiologic procedures. Radiology. 2002 Feb;222(2):375-82. doi: 10.1148/radiol.2222010528.
PubMed 11818602Montgomery 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.
PubMed 12032044Faymonville ME, Meurisse M, Fissette J. Hypnosedation: a valuable alternative to traditional anaesthetic techniques. Acta Chir Belg. 1999 Aug;99(4):141-6.
PubMed 10499382Flory 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.
PubMed 18638697Davidson 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.
PubMed 17900018
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02347748
- Acronym / sponsor ID
- 1000046792
- Conditions
- Anxiety, Pain, Adaptation, Psychological, Stress, Psychological
- Keywords
- Pain, Anesthesia Recovery Period, Postoperative Period, Adaptation, Psychological, Relaxation, Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A - Reading pre-procedure script | Experimental | Behavioral: Reading pre-procedure scriptPatients will be read a pre-procedure comfort talk script in the pre-procedure work-up area |
| Group B - Reading pre-extubation script | Experimental | Behavioral: Reading pre-extubation scriptPatients will be read a pre-extubation script; |
| Group C - Reading 2 scripts | Experimental | Behavioral: Reading pre-procedure script, Behavioral: Reading pre-extubation script, Behavioral: Reading 2 scriptsPatients will be read a pre-procedure comfort talk script in the pre-procedure work-up area Patients will be read a pre-extubation script |
| Group D | No intervention | –Patients will not be read any script |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Scheduled for cardiac catheterization
- Procedure performed under general anesthetic
- Ability to speak and understand English
- No apparent cognitive impairments
Key exclusion criteria (1 listed)
- Active dissociative psychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reading pre-procedure scriptPatients will be read a pre-procedure comfort talk script in the pre-procedure work-up area | Behavioural | Group A - Reading pre-procedure script, Group C - Reading 2 scripts |
| Reading pre-extubation scriptPatients will be read a comfort talk script before extubation | Behavioural | Group B - Reading pre-extubation script, Group C - Reading 2 scripts |
| Reading 2 scriptsPatients 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 | Behavioural | Group C - Reading 2 scripts |
Primary outcome
Pre-anesthesia Anxiety
Time frame: 3-15 min prior to anesthesia induction
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.
Postoperative Behavior
Time frame: 1 week postoperatively
Measured with the Post Hospitalization Behaviour Questionnaire (PHBQ)
11 secondary outcomes
Satisfaction with care
Time frame: 24-48 hrs after discharge from the hospital
Procedure Time
Time frame: Duration of the cardiac catheterization procedure (1-4 hrs depending on complexity of case)
Recovery room time
Time frame: within 24 hrs of procedure
Drug usage during procedure
Time frame: 1-4 hrs
Drug usage during recovery
Time frame: within 24 hrs
Antiemetics
Time frame: within 28 hrs
Anesthesia induction behavior
Time frame: within1 hr of anesthesia induction
Nausea
Time frame: within 28 hrs of procedure start
Rebleeds
Time frame: within 1 week of procedure
any pain
Time frame: within 28 hrs of arrival
Self-reported anxiety
Time frame: within 28 hrs of arrival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Background: PubMed 9322455Kain 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.
- Background: PubMed 18633018Varughese 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.
- Background: PubMed 19588390Yip 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.
- Background: PubMed 17462064Karling 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.
- Background: PubMed 10320165Kain 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. doi: 10.1097/00000539-199905000-00013.
- Background: PubMed 12641680Watson AT, Visram A. Children's preoperative anxiety and postoperative behaviour. Paediatr Anaesth. 2003 Mar;13(3):188-204. doi: 10.1046/j.1460-9592.2003.00848.x. No abstract available.
- Background: PubMed 10801169Lang 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. doi: 10.1016/S0140-6736(00)02162-0.
- Background: PubMed 16959427Lang 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. doi: 10.1016/j.pain.2006.06.035. Epub 2006 Sep 7.
- Background: PubMed 18503905Lang 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.
- Background: PubMed 15629969Butler 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. doi: 10.1542/peds.2004-0818.
- Background: PubMed 11818602Lang EV, Rosen MP. Cost analysis of adjunct hypnosis with sedation during outpatient interventional radiologic procedures. Radiology. 2002 Feb;222(2):375-82. doi: 10.1148/radiol.2222010528.
- Background: PubMed 12032044Montgomery 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacquie Viegas, RN principal investigator
Hospital for Sick Childen, Toronto, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reading pre-procedure script, Reading pre-extubation script and Reading 2 scripts in people with Anxiety and Pain, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-anesthesia Anxiety (time frame: 3-15 min prior to anesthesia induction). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02347748, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019; AzTrials last refreshed its copy on 2 Nov 2026.