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Pre-operative sleep promotion as prehabilitation to prevent post-operative delirium in the elderly (Brief: Sleep and Delirium) - Subarea I - Intervention, Subarea II - Patients' perspective and evaluation

Pre-operative sleep promotion as prehabilitation to prevent post-operative delirium in the elderly (Brief: Sleep and Delirium) - Subarea I - Intervention, Subarea II - Patients' perspective and evaluation - Sleep and delirium

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00027143
Enrollment
20
Registered
2021-12-09
Start date
2021-12-28
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F51.0 G47.0

Interventions

Group 1: Pre-inpatient: Four weekly individual sessions according to Buysse et al. (2011) "Brief behavioral treatment for insomnia". Setting is subject-oriented: Psychotherapy outpatient clinic, onlin

Sponsors

Evangelisches Klinikum Bethel Universitätsklinikum OWL Abteilung für Gerontopsychiatrie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: - Age: over 65 years and older - Patients who have an indication for an inpatient operation of any kind, and - who have an expected interval between the indication and the admission for surgery of at least four weeks. - Subjects with a sleep disorder with the following criteria: - Difficulty falling asleep or staying asleep or poor sleep quality occurring at least 3x/week for a period of at least one month. - There is excessive preoccupation with the sleep disorder at night and during the day and excessive worry about its negative consequences. - The unsatisfactory sleep duration or quality either causes significant distress or has a disruptive effect on daily activities. - The sleep disorder is seen as a diagnosis in its own right, even though it may be a symptom of another mental disorder or physical illness (such as pain or discomfort due to an underlying orthopedic condition, for example)

Exclusion criteria

Exclusion criteria: - Severe physical comorbidity where life expectancy is likely to be less than three months. - severe cognitive impairment - Evidence of untreated sleep apnea syndrome. - Evidence of untreated restless legs syndrome, periodic limb movement syndrome, or delayed sleep phase syndrome - bipolar disorder - untreated addictive disorders - driving heavy machinery or regular, long car trips

Design outcomes

Primary

MeasureTime frame
acceptance, tolerability - Qualitative, semi-standardized interview after completion of the intervention - Acceptance and tolerability is noted during the implementation of the intervention - treatment satisfaction (adapted version of ZUF-8) - Drop-out rate during the sleep promotion intervention (with reasons) Sleep quality Before-after change in sleep-related paramaters: - Pittsburgh Sleep Quality Index (PSQI, Buysse et al., 1991) - Insomnia Severity Index (ISI, Morin, C.M. 1993) - Sleep efficiency (SE), sleep quality, total sleep time (TST), latency to fall asleep (SOL), ability to sleep through the night (WASO) determined using a sleep diary (Müller & Paterok, 2010) Delirium incidence Peri-operative delirium incidence up to the 7th post-operative day or previous discharge using established delirium screening instruments such as ICDSC, NuDESC, 4AT

Secondary

MeasureTime frame
pre-post change in the following paramaters: - Number and type of sedatives taken - daytime sleepiness (Eppworth Sleepiness Scale, Johns, 1991) - Pain questionnaire (FESV) - Motor function by means of non-invasive digital 3-D video analysis of the movement or gait sequence

Countries

Germany

Contacts

Public ContactRabea Höke

Universität Bielefeld Fakultät für Psychologie und Sportwissenschaften

rabea.hoeke@uni-bielefeld.de0521/1064507

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026