Acupressure for agitation in nursing home residents with dementia: study protocol for a randomized controlled trial

BACKGROUND Agitation is prevalent among people with dementia (PWD) in nursing homes. It frustrates both the PWD and their caregivers. Acupressure is a non-pharmacological intervention whose effectiveness is supported by preliminary studies. However, there is still a dearth of evidence to explain its effect for clinical use and further research. The present study is being conducted primarily to investigate the effects of acupressure as compared with sham-acupressure and usual care. METHODS/DESIGN This study is a multicenter, assessor/participant/statistician-blinded, parallel group, randomized controlled trial taking place in Hong Kong nursing homes. We have been recruiting PWD over 65 years of age in nursing homes, who are experiencing agitation; 99 participants will be recruited in order to demonstrate a significant effect difference (that is, f =0.27) with a power of 0.8 and a significance level of 0.05 among the three groups. Participants are assigned by permuted block randomization into three groups in a 1:1:1 ratio. In the acupressure group, participants receive acupressure at the Fengchi (GB20), Baihui (GV20), Shenmen (HT7), Niguan (PC6) and Yingtang (EX-HN3) acupoints. In the sham-acupressure group, participants receive pressure on five non-acupoints. In the usual-care group, participants receive no intervention apart from the care provided by the nursing homes. Participants assigned to the sham-acupressure and usual-care groups receive free acupressure, like those in the acupressure group, after completion of the study. The whole study lasts for 30 weeks, and its primary outcome measure is agitation. The general estimated equation model will be used to compare the effects among groups and time points. The trial is currently recruiting participants. DISCUSSION This trial will provide a higher quality of evidence than previous studies on the use of acupressure for agitation in PWD. It will also provide newer evidence on acupressure in the population of PWD with agitation for clinical application and further research, including the effect on moderating stress, the delayed effect, the added effect on the placebo, and the effect on moderating the participant's use of psychotropic drugs. TRIAL REGISTRATION Centre for Clinical Trials Clinical Trials Registry: CUHK_CCT00347 (Registration date: 13 December 2012).