Effect of the Group-based Paro Intervention on Physiological and Psychological Outcomes
NCT05102201, Not applicable, Completed, National Tainan Junior College of Nursing
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effect of the Group-based Paro Intervention on Physiological and Psychological Outcomes | ClinicalTrials.gov |
| NCT number | NCT05102201 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 118 participants, actual | ClinicalTrials.gov |
| Lead sponsor | National Tainan Junior College of Nursing | ClinicalTrials.gov |
| Conditions | Dementia, Mild, Dementia Moderate, Cognitive Impairment | ClinicalTrials.gov |
| Interventions | Paro (social robot) intervention | ClinicalTrials.gov |
| First posted | 2021-11-01 | ClinicalTrials.gov |
| Last updated | 2022-09-28 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Oxytocin | Change from Baseline Oxytocin at 6 weeks | Blood samples for the oxytocin assay will collected from the antecubital vein into pre-chilled 5 ml EDTA tubes with 250 KIU of apoprotinin, and refrigerated until processing. | ClinicalTrials.gov |
| Primary | Finger tapping test (FTT) | Change from Baseline FTT at 6 weeks | The FTT consists of tapping with the index finger on a computer mouse as many times as possible within 60 second. | ClinicalTrials.gov |
| Primary | HRV measurements | Change from Baseline HRV at 6 weeks | It collects in this study using the Wireless Physiological Feedback System (Model NeXus 4) manufactured by Mind Media in the Netherlands. This device sets 400 signal acquisitions per minute and regularly corrects the device to maintain good reliability. Signal acquisition is managed, corrected, and heart rate frequency calculated by BioTrace+ software (Mind Media). Autonomic neuro physiological status reflect by the amplitude of high-frequency (HF) and low-frequency (LF) waveforms that were analyzed with the LF/HF ratio. | ClinicalTrials.gov |
| Primary | The Chinese version of Mini-Mental State Examination (MMSE) | Change from Baseline MMSE at 6 weeks | The MMSE is a widely used tool that screens for levels of cognitive impairment, using the concepts of orientation, registration, attention and calculation, recall, and language. The MMSE score ranges from 0 to 30. In general, a cut-off point higher than 24 indicates normal cognition; 20-23 mild cognitive impairment; 10-19 moderate cognitive impairment; and 0-9 severe cognitive impairment. | ClinicalTrials.gov |
| Primary | Core components of executive functions- WM and response inhibition | Change from Baseline WM and response inhibition at 6 weeks | The two core executive functions, WM and inhibition, were assessed using computerized tasks. Working memory was assessed using verbal WM and visuo-spatial WM tasks. Response inhibition was assessed using CWS, SS and GNG tasks. | ClinicalTrials.gov |
| Primary | Core components of executive functions- WM(1) -Verbal WM task | Change from Baseline Verbal WM task at 6 weeks | Verbal WM task: These are powerpoint slides. Each slide has different numbers of red circles with squares as distracters. The task is to count the total number of red circles in each slide, keep the total in memory and recall the numbers in the correct order. The test starts with a length of memory recall (span) of two, that is, the participant had to recall two slides first. Each level of memory recall consists of three trials and the test is concluded when the participant failed two trials out of three at that same length of recall. If the participant is successful in 2 out of three trials, he/ she is allowed to go to the next span. A total score is calculated after adding a mark for each correct recall. | ClinicalTrials.gov |
| Primary | Core components of executive functions- WM(2)-Visuo-spatial WM task | Change from Baseline Verbal WM task at 6 weeks | Visuo-spatial WM task: A 4 × 4 matrix with 16 squares is displayed on the computer screen as a pig house with a pig appearing in each window one at a time. The task is to recall in reverse order the locations where each target (pig) has appeared. The test start with a span length of two, that is, two pigs appear one after another. Each span consist of two trials and the test is concluded when the participant failed both trials at that same span length. Each correct location is given one point with a maximum score of 88. The score is taken as the measure of Visuo-spatial WM. At the end of the test, obtain score is automatically displayed on the computer screen. | ClinicalTrials.gov |
| Primary | Core components of executive functions- response inhibition (1)-Color word Stroop task | Change from Baseline Color word Stroop task at 6 weeks | Color word Stroop task: In this task different colour words will appear on the computer screen one at a time. The task is to name the color the word is printed, disregarding what the color word reads. The colour of the word printed is in the same color as the meaning of the word (congruent trials, eg; "red" is printed in red colour), or it is different from the meaning (incongruent trials, eg; word "green" is printed in blue colour). There are 75 congruent trials and 25 incongruent trials for one test session. Incorrect responses on incongruent trials are taken to assess the level of inhibitory control. The higher the errors the lower the interference control is. | ClinicalTrials.gov |
| Primary | Core components of executive functions- response inhibition (2)-Stop signal task | Change from Baseline Stop signal task at 6 weeks | Stop signal task: It assess the ability to inhibit ongoing responses. This is like a car game where a car appears on the computer screen. Every time the car appear, the participant is supposed to press a designated key as fast as possible to drive the car away. But when a stop-sign board appeared next to the car, participants has to refrain from pressing for the car to stand still. Each session in this task consist of 24 trials with six stop-signs-trials. Number of incorrect presses in stop sign (commission errors) is considered as the measure of inhibition and it is automatically displayed on the screen at the end of the task. | ClinicalTrials.gov |
| Primary | Core components of executive functions- response inhibition (3)-Go/no-go task | Change from Baseline Go/no-go task at 6 weeks | Go/no-go task (two versions: colour and shape): It assess ability to inhibit pre potent responses. The subject is presented with four different stimuli on the screen, one at a time in random order. There are two squares and two circles in blue and red. In the first session, the subject is instructed to respond by pressing a key each time when a blue figure appeared (go-trials) regardless of the shape, and not to respond when a red figure appear. In the second session, the subject is instructed to respond each time when a square appear, regardless of the color, and not to respond when a circle appear. Together the two consecutive sessions include 60 stimuli with 77% go-trials. The number of incorrect responses (commission errors) is used as a measure of inhibition and it is automatically displayed on the screen at the end of the task. | ClinicalTrials.gov |
| Primary | Geriatric Depression Scale - Short Form (GDS-SF) | Change from Baseline GDS-SF at 6 weeks | The GDS-SF consists of 15 items with 10 positive items and 5 negative items and has been found to be a useful tool to detect depressive symptoms in older populations. The scores range from 0-21 and a cut-off point of 6 or more indicates the presence of depression. | ClinicalTrials.gov |
| Primary | The UCLA Loneliness Scale version 3 (UCLA-3) | Change from Baseline UCLA-3 at 6 weeks | The UCLA loneliness is used to measure a person's subjective feelings of loneliness and feelings of isolation. Each item on the scale is rated from 1 (Never) to 4 (Often) with a total score ranging from 20 to 80. The scale does not identify a cut-off score that defines loneliness. The higher the score, the more severe a person's feelings of loneliness. | ClinicalTrials.gov |
| Primary | Warwick-Edinburgh Mental Well-being Scale (WEMWBS) | Change from Baseline WEMWBS at 6 weeks | The WEMWBS scale was developed by researchers at the Universities of Warwick and Edinburgh (2006), including 14 items of mental well-being covering subjective well-being and psychological functioning. The scale is scored by summing responses to each item answered on a 5 points Likert scale and the scores range from 14 - 70. The higher the score, the better the mental well-being. | ClinicalTrials.gov |
| Secondary | Group atmosphere | week-1, week-3 and week-10 | The Chinese version of the group climate questionnaire, 12 items, was developed by Zhong et al. (2013). This questionnaire consists three main dimensions including engagement (5 items), conflict (3 items), and avoidance (4 items). Each item on the scale is rated from 1 (Never) to 4 (Often) with a total score ranging from 12 to 48. The scale does not identify a cut-off score that defines good or bad group climate. The higher the score, the more better group atmosphere participant perceived. | ClinicalTrials.gov |
| Secondary | Group satisfaction | week-1, week-3 and week-6 | The group satisfaction scale was developed Keyton (1991). The Chinese version of group satisfaction scale, which consists 14 items, was translated and modified by Lin. This questionnaire consists five main dimensions including group process feelings, attitudes of leaders, attitudes of group members, group acceptance, group equality. Each item on the scale is rated from 1 (very satisfied) to 5 (very dissatisfied) with a total score ranging from 14 to 70.The higher the score, the more dissatisfied the group is. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Finger Tapping Task | Primary outcome | ConductCognition |
| Go/No-Go Task | Primary outcome | ConductCognition |
| Stop-Signal Task | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)