An observational study in Circadian Rhythm Sleep Disorder, Circadian Rhythm Disorder Caused by Drug and Circadian Rhythm Sleep Disorder, Jet Lag Type, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Completed at 1 site in Netherlands. Open to participants aged 1 Year to 11 Years. Per ClinicalTrials.gov, last updated 2024-07-31.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Observational
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.
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:
The following items will be extracted from the electronic health record:
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
139 studies on the registry are indexed under Sleep Disorders, Circadian Rhythm; 24 are open to participants now.
This study's enrollment of 100 is above the median of 64 across 31 observational studies indexed under Sleep Disorders, Circadian Rhythm.
Browse Sleep Disorders, Circadian Rhythm studies →Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) is the lead sponsor of 532 studies on the registry; 185 are open to participants now.
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Children aged 1-11 years planned for elective surgery or a procedure requiring general anaesthesia
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Children, aged between 1-11 years, who undergo general anesthesia because of surgery.
Children, aged between 1-11 years, who undergo general anesthesia because of an MRI.
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.
Time frame: Baseline (1wk before anesthesia) - First night post-anesthesia
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)
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 3 days pre-anaesthesia - 7 days post-anaesthesia
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Sleep Disorders, Circadian Rhythm →
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