Essay: Hypnotherapy as pretreatment for PSA in Children

ABSTRACT
Background
Relieve of pain and fear in children undergoing medical procedures can be achieved by either procedural sedation and analgesia (PSA) or hypnotherapy. We hypothesize that the combination of hypnotherapy and PSA is a valuable addition in the pain- and fear management in children. 
Objectives
To determine whether the use of hypnotherapy as pretreatment for PSA reduces pain, anxiety and distress in children undergoing diagnostic and therapeutic procedures.
Search methods
We searched MEDLINE, The Cochrane Library, The Cochrane Trial register, EMBASE, and psycINFO.
Selection criteria
Randomised and quasi-randomised control trials that compared hypnotherapy followed by any of the following sedative agents: nitrous oxide, midazolam, chloral hydrate, propofol or ketamine with the sedative agents mentioned above without hypnotherapy. The reports had to be published in English. 
Data collection and analysis
All review authors planned to independently select and assess studies yielded of the search. However, no eligible studies were identified. 
Main results
The search revealed no studies that fulfilled the in- and exclusion criteria. 
Author’s conclusions 
It is unknown whether hypnotherapy is effective as pretreatment for PSA in reducing pain, anxiety and distress in children undergoing medical procedures. Essay: Hypnotherapy as pretreatment for PSA in Children. 
This review highlights the need for studies that will investigate the effects of hypnotherapy combined with PSA in comparison to only PSA in children.
BACKGROUND
Medical procedures can be pain- and fearful experiences for children and their families.1 2 It causes behavioral distress and may lead to psychological problems and posttraumatic stress disorders.2 3 4 5 6 7 Previous studies demonstrate that children have the ability to accurately recall their fearful medical experiences, which may lead to intensified pain and distress in subsequent (invasive) medical procedures, potentially leading to failure of diagnostic and therapeutic procedures. 8 9 Therefore, adequate pain and fear management has received more attention in pediatric medical care during the recent years. A widely used procedure to alleviate fear and pain during diagnostic and therapeutic procedures is procedural sedation and analgesia (PSA), where sedative, analgesic or dissociative agents are administered. 10 As PSA is not necessarily performed in an operating room (OR), leading to logistical and economic advantages compared to procedures requiring the OR, PSA is increasingly used by pediatricians.11 Effective and generally used drugs for PSA are nitrous oxide, midazolam, chloral hydrate, propofol and ketamine. 12 13 14

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As introduction of PSA in children could lead to the experience of fear as well, the addition of a behavioral and/or psychological technique that would minimize this anxiety (e.g. hypnotherapy) could positively influence the outcome of PSA.8 Hypnotherapy is a state of mind that involves increased susceptibility to suggestion and focused attention towards positive inner experiences, leading to distraction from the medical procedure. 9 15 16 17 It has been proven effective in reducing pain, anxiety and distress in children exposed to variable medical treatment procedures (e.g venipuncture, bone marrow aspirations, lumbar punctures, voiding cystourethrograms, nuss procedure). 9 18 19 

To our knowledge, there is little evidence regarding the role of pediatric hypnotherapy as pre-treatment before PSA to minimize anxiety. Several reviews have been published evaluating psychological interventions and its positive effect in the management of pain, anxiety and distress in children undergoing medical procedures. Unfortunately, these reviews are out of date and/or no studies regarding hypnotherapy (combined with PSA) are included. 20 21 22 19 23 24 One of the studies discussed in the review of Powers et al. concluded the positive effect of psychological intervention combined with midazolam and morphine before a medical procedure compared to administration of midazolam and morphine only.25
In our opinion, hypnotherapy as pretreatment before PSA in children might be a promising addition to pain and fear management in children, hence the need for this review.Essay: Hypnotherapy as pretreatment for PSA in Children.
Objectives
This review aims to systematically review what is known about the effects of hypnotherapy as pre-treatment before PSA with nitrous oxide, midazolam, chloral hydrate, propofol or ketamine in children. We will focus on the following study questions:
1) Is the effect of hypnotherapy beneficial in PSA using nitrous oxide
2) Is the effect of hypnotherapy beneficial in PSA using midazolam
3) Is the effect of hypnotherapy beneficial in PSA using chloral hydrate
4) Is the effect of hypnotherapy beneficial in PSA using propofol
5) Is the effect of hypnotherapy beneficial in PSA using ketamine
Hypothesis
We hypothesize that hypnotherapy reduces anxiety, fear, and behavioral distress before and during PSA and that it would positively influence the results regarding pain, and comfort for children.
METHODS
Population and study design
We conducted a systematic review of published literature to evaluate what is known about hypnotherapy as pretreatment for PSA with nitrous oxide, midazolam, chloral hydrate, propofol or ketamine in children.
Eligibility criteria for selecting studies for this review
Types of studies
Both randomised and quasi-randomised control trials were included. Case control studies were not included to avoid bias. To be included a study had to be published in the English language.
Types of participants
– All children and adolescents up to 18 years of age.
Ages were subdivided according to the age definitions used by the Medical Subject Headings introduced by the United States National Library of Medicine in 1998:
• Infant: 0-2 years of age
• Preschool Child: 3 to 5 years
• Child: 6 to 12 years
• Adolescent: 13 up to 18 years old.
– Children having any procedural sedation and analgesia with either nitrous oxide, midazolam, chloral hydrate, propofol or ketamine. Children were included regardless of baseline anxiety.
Types of interventions
Test group; Any hypnotherapeutic technique followed by any of the following sedative agents: nitrous oxide, midazolam, chloral hydrate, propofol or ketamine (regardless of route of administration).
Control group; any of the sedative agents mentioned above without any hypnotherapeutic technique.
Types of outcome measures
(1) Completion of treatment (yes/no).
(2) Measures of behavior between test and control groups (scales used may vary between studies). Essay: Hypnotherapy as pretreatment for PSA in Children.
(3) Difference in post-operative anxiety between test and control groups (scales used may vary between studies).
(4) Adverse events.
Search methods for identification of studies
For identification of relevant studies for this review, we searched up to January 2016 in the following online medical databases: MEDLINE, The Cochrane Library, The Cochrane Trial register, EMBASE, and psycINFO. We used a detailed search strategy for each database based on the search strategy developed for MEDLINE (table 1). No limits were used. To further ensure that all published studies were identified we searched with the aid of a professional librarian. Specialists in the field known to the review authors were contacted for any unpublished data.
Data collection and analysis
Selection of studies
The final eligible lists of studies for all databases were combined and reviewed for final inclusion in the study. Selection of papers suitable for inclusion in the review was carried out independently by two review authors (E. de Sonnaville and Y. van Berkel/G.Kuiper). Titles and abstracts were assessed and full copies of all relevant and potentially relevant studies, those appearing to meet the inclusion criteria, or for which there were insufficient data in the title and abstract to make a clear decision, were obtained. These two review authors assessed the full text papers independently. All irrelevant records were excluded and details of the studies with the reasons for their exclusion were noted. Agreement was planned to be assessed by calculating Kappa scores. Values of kappa between above 0.60 and 0.75 reflect respectively good agreement and excellent agreement (Orwin 1994). Essay: Hypnotherapy as pretreatment for PSA in Children. A fourth review author (F. Kreier) was available to resolve any issues or selection discrepancies that arose. All disagreements were resolved by discussion.
Methodological quality
The two reviewers (EdS and GK) were assigned to independently assess the methodological quality of the studies by use of the Cochrane Collaboration Risk of BiasTool (CCRBT) {Cochrane Handbook for Systematic Reviews of Interventions}. We planned to categorize the included studies as ‘Low risk’ of bias, ‘High risk’ of bias or ‘Unclear risk’ of bias, and are displayed in a ‘Risk of bias summary figure’. Results were compared to check for inconsistencies and disagreements were resolved by consensus. Review authors were not blinded to the journal of publication or the author’s names.
Data extraction and management
The two reviewers (EdS and GK) had planned to independently extract data from included trials. Baseline characteristics of the studies, and number of patients randomized and analyzed, were planned to retrieve. Study endpoints were planned to extract as numbers (with percentages) or as mean(s.d.) values where appropriate. We planned to count the number of patients with complications. In case information was missing, it was planned to make an attempt to contact the authors to clarify details and/or to request missing data on outcome. Results were compared to check for inconsistencies and disagreements were resolved by consensus. Review authors were not blinded to the journal of publication or the author’s names.
Statistical analysis
Outcomes were planned to analyze as continuous or dichotomous variables, using standard statistical techniques available in the Review Manager program RevMan version 5 {The Cochrane Collaboration, The Nordic Cochrane Centre, Copenhagen, Denmark}. For continuous outcomes, the weighted mean difference and 95 per cent confidence interval (c.i.) were planned to calculate. For dichotomous outcomes, the odds ratio (OR) was supposed to be calculated with 95 per cent c.i. To test the heterogeneity of trial results we beforehand planned to perform the Higgins χ2 test, and the I2 statistic was supposed to give an estimate of the degree of heterogeneity. I2 values over 50 per cent would indicate considerable heterogeneity {Higgins:2003hz}. Essay: Hypnotherapy as pretreatment for PSA in Children.
RESULTS
Description of studies
The electronic search provided 532 records resulting in 407 records after removal of duplicates. Based on title and abstract 72 studies were selected. Reading full text of these studies showed none of them complied the inclusion and exclusion criteria.
Results of the search
No eligible studies have been found.
Risk of bias in included studies
Not applicable as no studies have been identified.
DISCUSSION
The search revealed no studies that accomplished the inclusion criteria for the evaluation of hypnotherapy as pretreatment for PSA with nitrous oxide, midazolam, chloral hydrate, propofol or ketamine in children.
The study of Lu et al was the only who investigated the combination of hypnotherapy with PSA (ketamine sedation) in children prior to operative dental work. All children had a history of ketamine sedation with violent and emotional behavior during the induction and recovery period. When hypnotherapy was added almost all patients were calm and relaxed during the entire sedation procedure, suggesting a positive influence of the addition of hypnotherapy in PSA. 26 As this study has several limitations, including the lack of a control group, it had to be excluded from our review.
It is notable that hypnotherapy as pretreatment of general and local anesthesia has been studied for decades. Nagle et al. reported in 1961 that the majority of children evaluated in their study established trance and relaxation due to hypnotherapy prior to induction of general anesthesia.27 Lobe et al. reported reduced hospital stay in patients receiving perioperative hypnotherapy, focused on postoperative pain management, in comparison with patients receiving no hypnotherapy before undergoing general anesthesia.28 In addition, Calipel and colleagues have proven the beneficial effect of hypnotherapy over midazolam on anxiety and perioperative behavioral disorders, both administrated as premedication before surgery.29 According hypnotherapy as pretreatment of local anesthesia, the well-designed RCT of Liossi and colleagues confirmed that patients receiving self-hypnotherapy combined with local anesthesia (EMLA) reported less anxiety, less pain and less behavioral distress during venipuncture compared to a group of patients that only received EMLA and a group that received EMLA combined with attention.30
In the RCT of Fortifier et al. the effect of therapeutic suggestion on postoperative nausea and vomiting in children receiving anesthesia prior to a tonsillectomy and adenoidectomy was evaluated.Essay: Hypnotherapy as pretreatment for PSA in Children. All children were wearing headphones and listening to either a therapeutic suggestion, a story or to standard operating room noise. Despite the fact that therapeutic suggestion did not seem to have any impact on postoperative nausea and vomiting, the use of headphones for blinding were of great inspiration for following studies.31
Taken into account that none of the discussed studies were eligible for the current review, the positive effect of the use of hypnotherapy before PSA or anesthesia in children showed through. Furthermore, previous studies and clinical experience has taught us that administration of for example nitrous oxide solely for PSA may be inadequate to achieve complete sedation. 32 33 As triggering the senses of smell, vision, touch and noise easily disturbs the sedation effect of NO, it is important that the child is in a quiet and relaxed surrounding. For achieving adequate sedation that will lead to alleviation of pain, anxiety and discomfort in children undergoing medical procedures, optimizing the use of hypnotherapy as pretreatment of PSA is necessary. Not at least, since the introduction of the mask has shown a peak of the anxiety level in children pre-anesthesia.34
Implications for practice
The role of hypnotherapy as pretreatment before PSA with nitrous oxide, midazolam, chloral hydrate, propofol or ketamine in children is unknown.
Implications for research
There was a lack of studies evaluating the effects of hypnotherapy as pre-treatment before PSA with nitrous oxide, midazolam, chloral hydrate, propofol or ketamine in children. The conclusion of this study warrants studies to evaluate the effects of hypnotherapy combined with PSA in comparison to only PSA in children. Essay: Hypnotherapy as pretreatment for PSA in Children.
ACKNOWLEDGEMENTS

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Bert Berenschot, librarian
Lea Dijksman, research coordinator
REFERENCES
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TABLES AND FIGURES
Risk of bias summary figure – example.Essay: Hypnotherapy as pretreatment for PSA in Children.