Long-term consequences of pain, anxiety and agitation in older, critically ill patients after a stay on an intensive care unit

Long-term consequences of pain, anxiety and agitation in older, critically ill patients after a stay on an intensive care unit - a prospective, observational study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN52754370

Enrollment

300

Registered

2011-07-06

Start date

2008-12-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

ICU patients Not Applicable

Interventions

1. Background data will be gathered via medical records and questionnaires 2. Medical and nursing staff will gather daily routine data regarding pain, anxiety, and agitation, along with any other info

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Minimum age of 65 years 2. Have had an ICU stay of at least 48 hours (ICU group) or no stay for the last 15 years (comparison group) 3. Be able to speak and read either German or French, and live in Switzerland

Exclusion criteria

Exclusion criteria: 1. Temporary tracheostomies 2. Chronic mechanical ventilation 3. Illness-related cognitive impairment (dementia) 4. Psychotic illnesses including delusions and changes in mental state 5. Potentially terminal illnesses such as lung or heart diseases and cancer

Design outcomes

Primary

Measure	Time frame
1. Pain, anxiety and agitation during an ICU stay 2. During the ICU stay, pain, anxiety and agitation will be measured in the ICU group 3. In patients unable to verbally express themselves, pain intensity will be measured using a behavioural pain scale employing three behavioural parameters: 3.1. Mimic 3.2. Body movement 3.3. Muscle tone 4. The intensity of the behavioural parameters will be assessed on the basis of a four-point Likert scale: each characteristic will be rated as weak or absent, moderately severe, severe, or very severe 5. Anxiety will be assessed using a numeric rating scale (0-10) (0=no anxiety to 10=worst possible anxiety) 6. Agitation during the ICU stay will be measured using the German version of the Richmond Agitation-Sedation Scale (RASS), which has 10 levels, ranging from -5: unarousable (no response) to +4: combative (danger to staff) 6. This scale has proven reliable for the assessment of critically ill patients in the ICU, with strong interrater reliability and criterion, construct, and face validity 7. The Confusion Assessment Method for the ICU (CAM-ICU) will be used to assess delirium in the ICU, as well as general cognitive abilities, focusing on the following factors: 7.1. Acute onset or fluctuating course 7.2. Inattention 7.3. Disorganized thinking 7.4. Altered level of consciousness After discharge: 1. In line with the study aims, the following outcome indicators will be measured in both the ICU group and the comparison group: 1.1. Pain, anxiety and agitation 1.2. HRQOL 1.3. Use of the health care system (readmissions, general practitioner visits, rehabilitation, length of hospital stay), medication use, living situation and survival 2. Pain intensity will be measured with a numeric scale (NRS) (0=no pain to 10=worst possible pain), and pain frequency with a Likert-type scale (never, seldom, occasionally, often, always) 3. Anxiety will be assessed using a numeric rating scale (0-10) and the Hospital Anxiety and Depression Scale	—

Measure

Time frame

1. Pain, anxiety and agitation during an ICU stay 2. During the ICU stay, pain, anxiety and agitation will be measured in the ICU group 3. In patients unable to verbally express themselves, pain intensity will be measured using a behavioural pain scale employing three behavioural parameters: 3.1. Mimic 3.2. Body movement 3.3. Muscle tone 4. The intensity of the behavioural parameters will be assessed on the basis of a four-point Likert scale: each characteristic will be rated as weak or absent, moderately severe, severe, or very severe 5. Anxiety will be assessed using a numeric rating scale (0-10) (0=no anxiety to 10=worst possible anxiety) 6. Agitation during the ICU stay will be measured using the German version of the Richmond Agitation-Sedation Scale (RASS), which has 10 levels, ranging from -5: unarousable (no response) to +4: combative (danger to staff) 6. This scale has proven reliable for the assessment of critically ill patients in the ICU, with strong interrater reliability and criterion, construct, and face validity 7. The Confusion Assessment Method for the ICU (CAM-ICU) will be used to assess delirium in the ICU, as well as general cognitive abilities, focusing on the following factors: 7.1. Acute onset or fluctuating course 7.2. Inattention 7.3. Disorganized thinking 7.4. Altered level of consciousness After discharge: 1. In line with the study aims, the following outcome indicators will be measured in both the ICU group and the comparison group: 1.1. Pain, anxiety and agitation 1.2. HRQOL 1.3. Use of the health care system (readmissions, general practitioner visits, rehabilitation, length of hospital stay), medication use, living situation and survival 2. Pain intensity will be measured with a numeric scale (NRS) (0=no pain to 10=worst possible pain), and pain frequency with a Likert-type scale (never, seldom, occasionally, often, always) 3. Anxiety will be assessed using a numeric rating scale (0-10) and the Hospital Anxiety and Depression Scale

—

Secondary

Measure	Time frame
1. Use of the health care system (readmissions, general practitioner visits, rehabilitation, length of hospital stay) 2. Medication use 3. Living situation and survival	—

Countries

Switzerland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026