Changes in Circadian Rhythm After Anaesthesia in Children

Study Overview
=================
Brief Summary
-----------------
In this study the investigators will examine the effect of general anesthesia and surgery on sleep duration and sleep quality in children, using questionnaires and a sleep diary.

Detailed Description
-----------------
Objective: The primary objective is to assess the effect of general anaesthesia and surgery on sleep duration (chronotype) and sleep quality in children aged 1-11 years in the first week after surgery. Secondary objectives are to determine the duration of the effect of general anaesthesia on chronotype and sleep quality. Furthermore, the investigators will examine factors which may be of influence on the quality and duration of sleep, like postoperative emergence delirium, admission to the hospital, Face, Legs, Activity, Cry, Consolability scale (FLACC) / Numeric Rating Scale (NRS) scores, preoperative sedative medication and postoperative sedative medication. Study procedures: Possible participants will be identified on the anaesthetic pre-operative assessment clinic and asked if they object to a phone call with information about research. If not, a researcher will contact the parents by telephone to inform them about the study. After oral consent by both parents, an invitation to fill in the questionnaires will be sent to the parents together with a consent form. Informed consent by both parents will be obtained. Questionnaires can be completed online or on paper, depending on the parents' preference. Questionnaires: Sleep quality: Child's Sleep Habits Questionnaire (CSHQ) on day 3 preoperative and on day 7 postoperative. Chronotype: Children's chronotype questionnaire on day 3 preoperative Daily sleep diary starting from 3 days preoperative until 7 days postoperative The following items will be extracted from the electronic health record: Demographic criteria: age, gender, type of procedure Admission dates Preoperative sedative medication Postoperative sedative medication NRS/FLACC scores during hospital stay All items will be entered in an electronic database (CASTOR) Primary endpoint The diurnal phase shift the night after surgery, measured by comparing the midpoint of sleep three nights before surgery (as measured by the sleeping log) with midpoint of sleep the night after surgery. Secondary endpoints Change in sleep quality as measured with the CSHQ questionnaire Incidence of postoperative sleep problems as measured with the CSHQ questionnaire Difference in sleep problems, sleep duration and sleep quality between children who had anaesthesia for magnetic resonance imaging and children who had anaesthesia and surgery Influence of pain and sedative medication on sleep duration and quality

Official Title
-----------------
The Effect of General Anaesthesia and Surgery on Sleep-wake Timing in Children: the CLOCKS Kids Observational Study

Conditions
-----------------
Circadian Rhythm Sleep Disorder, Circadian Rhythm Disorder Caused by Drug, Circadian Rhythm Sleep Disorder, Jet Lag Type, Jet Lag, Anesthesia, Sleep, Sleep Disorders, Circadian Rhythm, Sleep Disturbance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: General anaesthesia for surgery or magnetic resonance imaging (MRI) with a minimal duration of 30 minutes Age 1-11 years Informed consent of both parents Exclusion criteria: Parents are not fluent in Dutch Known severe sleep disturbances Postoperative admission to paediatric intensive care unit Moderate to severe developmental disorder (IQ<85) American Society of Anesthesiologists (ASA) classification > 3

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 11 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children who undergo anesthesia because of surgery<br>Children, aged between 1-11 years, who undergo general anesthesia because of surgery. | |
| Children who undergo anesthesia because of an MRI<br>Children, aged between 1-11 years, who undergo general anesthesia because of an MRI. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diurnal phase shift | The diurnal phase shift the night after surgery, measured by comparing the midpoint of sleep three nights before surgery (as measured by the sleeping log) with midpoint of sleep the night after surgery. | Baseline (1wk before anesthesia) - First night post-anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sleep quality | The change in subjective sleep quality, including incidence of sleep problems (e.g. sleepwalking, nightmares), as measured by the Children's Sleep Habits Questionnaire (CSHQ), between the month prior to 3 nights pre-anesthesia and 1 week post-anesthesia. This is measured on a likert scale 1 meaning no sleep problems and 5 meaning a lot of sleep problems. The answers from questionnaire 1 (3 days preoperative) are compared to answers of questionnaire 2 (7 days postoperative) | 3 days pre-anaesthesia - 7 days post-anaesthesia | 
| Changes in all sleep times | Changes in all sleep parameters (i.e. sleep on- and offset times, sleep duration, sleep latency) when comparing baseline (as measured by the Children's ChronoType Questionnaire (CCTQ) 3 days pre-anesthesia) to all 10 nights of the sleeping log. | 3 days pre-anaesthesia - 7 days post-anaesthesia | 
| Difference in sleep quality between children who had anaesthesia for magnetic resonance imaging and children who had anaesthesia and surgery | Difference in subjective sleep quality (as measured by the CSHQ) between patients receiving anesthesia for magnetic resonance imaging and patients receiving anesthesia for a surgical procedure. Answers are on a likerts scale with 1 meaning no sleep problems and 5 meaning a lot of sleep problems. | 3 days pre-anaesthesia - 7 days post-anaesthesia | 
| Difference in sleep-wake timing | Difference in changes in sleep-wake timing (as measured by the sleeping log, units are minutes) between patients receiving anesthesia for magnetic resonance imaging and patients receiving anesthesia for a surgical procedure | 3 days pre-anaesthesia - 7 days post-anaesthesia |