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NRI 95-192 – HSR Study

NRI 95-192
Pain Management and Behavioral Outcomes in Patients with Dementia
Marilyn K. Douglas, DNSc RN FAAN
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, CA
Funding Period: October 1997 - March 2001
Dementia illness often co-exists with painful medical conditions associated with aging (e.g., degenerative joint disease, osteoarthritis, skin ulcers, back pain, headaches, cancer, or angina). While the standard practice is pain assessment for all patients, the elderly with dementia have special needs for assessment, management, and evaluation. When they are unable to verbalize pain, objective measurement of their discomfort are possible manifestations of pain. No research relates systemic pain treatment with reduction of negative problematic behaviors in patient dementia.

The objectives of this research are (1) to elucidate the relationships between pain, discomfort, and agitation; and (2) to determine the influence that pain management has on decreasing the outcomes of discomfort, agitation, and confusion in nursing home residents.

This study used a randomized, double-blind, placebo-controlled, cross-over design. Each treatment arm lasted two weeks. The crossover point occurred without washout. One arm was acetaminophen 650 mg qid and placebo qid PRN. The other arm was placebo qid and acetaminophen 650 mg qid PRN. Sites involved in the study included the Jewish Home for the Aged in San Francisco; Golden Gate Healthcare Center in San Francisco; Palo Alto VA Health Care System; Nursing Home Care Unit at Livermore. Patients were included who: are > 55 years; have severe dementia; have a documented painful condition not requiring opiates or a current medication regimen; unable to report pain consistently or reliably; be present and accept treatment for study duration; have > 1 episode of agitation per day. Patients with schizophrenia or severe Parkinson’s are excluded. A research assistant (blind to treatment arm) tested each patient for discomfort, agitation, and confusion at baseline and two times per day on two days of the week for four weeks. Nurses rated patients for agitation each shift. Instruments included the Cohen-Mansfield Agitation Inventory, the Discomfort Scale, and the Confusion Assessment Method. Repeated measures analyses examined effect of treatment on the three behaviors (agitation, confusion, and discomfort).

Findings on 39 participants who completed the study (5 men, 34 women), at baseline, revealed a mean age of 87.5 (SD 7.9) years, a mean Mini-Mental State Exam of 5.3 (SD 5), mean Global Deterioration Scale score of 5.7 (SD 0.4), mean Discomfort Scale score of 10.7 (SD 6.8), and a mean agitation score of 33.2 (SD 4.1). The most frequently reported agitated behaviors included restlessness, repetitive mannerisms, strange noises, attempts to leave, wandering, and screaming. Approximately 84 percent had degenerative joint processes. While screening for pain using the Pain Screening Tool, 70 percent were completely unable to give an answer about pain and 30 percent were inconsistent (unintelligible) in their response about pain. There was a strong and significant positive baseline correlation between discomfort and agitation (r=0.581, p=0.001) and between severity of dementia and agitation (r=0.36, p=0.01). There were no differences between the acetaminophen and placebo arms in summed mean discomfort (t=.249, NS), agitation (t=1.39, p=018, NS) or confusion scores (there were no incidences of delirium). After controlling for severity of dementia, the change in agitation scores between acetaminophen and placebo arms was significantly associated with the change in discomfort scores between acetaminophen and placebo arms (F=4.09; df=2.13; p=0.041). Those patients whose comfort was relieved with acetaminophen also had less agitation.

The strong and significant positive relationship between agitation and discomfort suggests that patients with severe dementia have agitated behaviors that may be attributable to pain and/or other causes. Agitation and discomfort are closely related. When discomfort is relieved, there is a strong likelihood that agitation will decrease. This study is a beginning effort to offer pain management in this population. Investigators are needed that address individualized pain assessment regimens.

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DRA: Mental, Cognitive and Behavioral Disorders, Aging, Older Veterans' Health and Care
DRE: Treatment - Observational
Keywords: Dementia, Nursing, Pain
MeSH Terms: Patient-Centered Care, Nursing, Dementia, Pain

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