Tokyo, May 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061606) titled 'Study on the Effects of a Manicure Intervention in Older Women with Dementia' on May 18.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Hiroshima University
Condition:
Condition - Dementia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study was to investigate the effects of a manicure intervention on behavioral and psychological symptoms of dementia (BPSD), cognitive function, quality of life (QOL), and caregiver burden in older women with dementia residing in welfare facilities.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Participants in the intervention group received a manicure intervention for approximately 15 minutes once every two weeks for 6 months. The intervention consisted of the application of a base coat, colored manicure selected by the participant, and a top coat. The intervention was conducted individually in a quiet environment while communicating face-to-face with the participants.
Interventions/Control_2 - Participants in the control group received hand and nail cleansing followed by moisturizing care. The duration and frequency of the intervention were the same as those in the intervention group.
Eligibility:
Age-lower limit - 65
years-old
=
Gender - Female
Key inclusion criteria - 1. Older women diagnosed with dementia by a physician
2. Residents of welfare facilities
3. Participants able to maintain a seated position for approximately 20 minutes during the intervention
4. Participants without skin problems or allergies affecting the hands or fingers
5. Participants who provided written informed consent personally or through a legally authorized representative
Key exclusion criteria - 1. Participants who were unable to understand the study procedures or tolerate the approximately 20-minute intervention
2. Participants for whom informed consent could not be obtained from family members or legally authorized representatives
Target Size - 120
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2019 Year 06 Month 20 Day
Date of IRB - 2019 Year 06 Month 20 Day
Anticipated trial start date - 2026 Year 05 Month 20 Day
Last follow-up date - 2026 Year 05 Month 21 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070486
Disclaimer: Curated by HT Syndication.