Doll Therapy Efficacy for People With Dementia Living in Nursing Homes: a Randomized Single-blind Controlled Trial
NCT03224143 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128
Last updated 2017-07-21
Summary
This study is a randomized single-blind controlled trial with parallel arms.The present study is based on that previously published by Pezzati and collegues (2014) and it is part of a larger project focusing on Doll Therapy dissemination in Canton Ticino through team training and supervision and guidelines definition that led to the establishment of the Ticino Doll Therapy Group with support of the Canton Office for elderly and home care.
The first hypothesis regards the 30 days-effectiveness efficacy of the Doll Therapy intervention in reducing symptoms of behavioral disorders (BPSD) that appear in stressful situations (as in the case of a separation from a professional caregiver) and in reducing stress as perceived by the treating physician. Another issue to be investigated is whether the typical way in which a person manifested attachment behaviors during own life (classified in three types of mental states: secure, insecure and unresolved) is associated, once this person is in an advanced stage of dementia, with caregiving behaviors of the PWD during the doll presentation (i.e. caressing the object, talking to it and smiling).
Conditions
Interventions
- BEHAVIORAL
-
Doll Therapy Intervention
Daily sessions, lasting an hour, will take place in a room known to patients (P). The only people in the room will be a nurse (N) and the researcher with video-tape, never interacting with P. The procedure is: the N will accompany the P in the room and the P will take a seat. The N will put the doll in front of the P and will say "Good morning Mr./Mrs....look", with a quiet voice. If the P will not take it at the first attempt, the N will sit down in front of her holding the doll in the arms and will wait for 2 minutes. The N will invite the PWD again. If the P will not take the doll after the second request, the N will not insist and she will leave. If the doll will be taken, the N will leave the P and say "I have to go, goodbye Mr./Mrs. . . ..". The gaze will always be upon the P.
- BEHAVIORAL
-
active control group (SI)
Daily sessions, lasting an hour, will take place in a room known to patients (P). The only people in the room will be a nurse (N) and the researcher with video-tape, never interacting with P. The procedure is: the N will accompany the P in the room and the P will take a seat. The N will put the cube in front of the P and will say "Good morning Mr./Mrs....look", with a quiet voice. If the P will not take it at the first attempt, the N will sit down in front of her holding the cube in the arms and will wait for 2 minutes. The N will invite the PWD again. If the P will not take the cube after the second request, the N will not insist and she will leave. If the cube will be taken, the N will leave the P and say "I have to go, goodbye Mr./Mrs. . . ..". The gaze will always be upon the P.
Sponsors & Collaborators
-
Fondazione Golgi Cenci
collaborator OTHER -
University of Turin, Italy
collaborator OTHER -
Gruppo Doll Therapy Ticino
collaborator UNKNOWN -
Case per Anziani Canton Ticino
collaborator UNKNOWN -
Centro di Terapia Cognitiva, Como
collaborator UNKNOWN -
University of Applied Sciences and Arts of Southern Switzerland
lead OTHER
Principal Investigators
-
Rita Pezzati · University of Applied Sciences and Arts of Southern Switzerland
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-02-16
- Primary Completion
- 2020-02-16
- Completion
- 2020-02-16
Countries
- Switzerland
Study Locations
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