CLOCKSkids: Changes in Circadian Rhythm After Anaesthesia in Children

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)

Overall Status

Recruiting

CT.gov ID

NCT05618405

Collaborator

(none)

200

Enrollment

Location

23.5

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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

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

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 16, 2022

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Children who undergo anesthesia because of surgery Children, aged between 1-11 years, who undergo general anesthesia because of surgery.
Children who undergo anesthesia because of an MRI Children, aged between 1-11 years, who undergo general anesthesia because of an MRI.

Outcome Measures

Primary Outcome Measures

The diurnal phase shift [Baseline (1wk before anesthesia) - First night post-anesthesia]
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 Outcome Measures

Change in sleep quality [3 days pre-anaesthesia - 7 days post-anaesthesia]
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)
Changes in all sleep times [3 days pre-anaesthesia - 7 days post-anaesthesia]
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.
Difference in sleep quality between children who had anaesthesia for magnetic resonance imaging and children who had anaesthesia and surgery [3 days pre-anaesthesia - 7 days post-anaesthesia]
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.
Difference in sleep-wake timing [3 days pre-anaesthesia - 7 days post-anaesthesia]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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