Harris 2012.

Study characteristics
Methods	Study design: RCT Follow‐up: day 3–4
Participants	Country: USA, southeast Setting: 4 long‐term care facilities Inclusion criteria: English speaking aged ≥ 65 years chart diagnosis of dementia from the medical record ability to follow simple commands resident of the facility for > 90 days sleep disturbance, defined as < 7 hours (420 minutes) of night‐time sleep determined by a mean of 48 hours of actigraphy data Exclusion criteria: unstable medical condition integumentary condition such as herpes zoster, sutures, decubitus ulcer or rash that would interfere with the slow‐stroke back massage vertebral fracture or recent fall Number of participants completing the study: 40 (IG 20, CG 20) Baseline characteristics: age (years, mean): IG 84.6 (SD 6.11), CG 87.5 (SD 6.78) gender (female): IG 14 (70%), CG 17 (85%) MMSE total score (mean): IG 8.15 (SD 6.83), CG 12.9 (SD 7.1) Group differences: significantly lower MMSE scores in IG more people with Alzheimer's disease in IG
Interventions	Intervention: a certified geriatric advanced practice nurse was trained in slow‐stroke back massage and performed 3 minutes of massage for 2 nights at bedtime in residents' rooms. Control: usual bedtime care
Outcomes	Night‐time total sleep, hours/minutes (actigraphy) Wake after sleep onset (actigraphy) Daytime total sleep, hours/minutes (actigraphy)
Funding	Sponsorship source: John A. Hartford Scholarship NGNA (National Gerontological Nursing Association) Mary Wolanin Graduate Scholarship Sigma Theta Tau Gamma Xi Research Award
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Sequence generation	Low risk	Participants sleeping < 7 hours (420 minutes) based on actigraphy data were randomly assigned to IG or CG. The Number Crunching Statistical Software was used to generate a table of random numbers and a randomisation schedule for the allocation sequence as participants were enrolled in the study (Hintze 2005).
Allocation concealment	Unclear risk	A randomisation schedule for the allocation sequence as participants were enrolled in the study. After consensus with Ralph Möhler.
Blinding of participants and personnel All outcomes	Unclear risk	Unknown.
Blinding of participants and personnel Subjective sleep quality (carer ratings)	Unclear risk	Unknown.
Blinding of participants and personnel Objective sleep measures	Unclear risk	Unknown.
Blinding of outcome assessors Objective outcome measures	Low risk	Actigraphy.
Blinding of outcome assessors Subjective sleep quality (carer ratings)	Unclear risk	No information available.
Incomplete outcome data All outcomes	Low risk	No attrition.
Selective outcome reporting	Unclear risk	No protocol identified.
Other sources of bias	Low risk	Short duration: 3‐minute slow‐stroke back massage at bedtime for 2 nights.