Dementia, MildNCT05102201
Effect of the Group-based Paro Intervention on Physiological and Psychological Outcomes
A study testing Paro (social robot) intervention in people with Dementia, Mild and Dementia Moderate, run by National Tainan Junior College of Nursing at 1 site in Taiwan.
Trial summary
This project contains three studies. This study will use a pilot randomized controlled trial to examine the effect of Paro (social robot) intervention on oxytocin, dopamine, and HRV variations and mental well-being for specific attachment older adults with dementia. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Mild, Dementia Moderate, Cognitive Impairment
- What is being tested?
- Paro (social robot) intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Mar 2022to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- aged 65 years or over; (2) Mild to moderator dementia (3) an ability to communicate in Mandarin or Taiwanese; and (4) has been living in the LTC facility at least 3 months
Who cannot join
- have severe difficulty in communication; (2) are totally dependent on carers for daily activity; (3) have a diagnosed infectious disease, severe dementia, and severe mental illness such as schizophrenia and delusional disorder
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Cheng Kung University Hospital Dou-Liou Branch
Douliu, 640
About this study
Official title: National Tainan Junior College of Nursing
This project contains three studies. This study will use a pilot randomized controlled trial to examine the effect of Paro (social robot) intervention on oxytocin, dopamine, and HRV variations and mental well-being for specific attachment older adults with dementia. A randomized controlled trial, single-blind, two parallel groups, and repeated measures design were used to examine the effects of Paro intervention on neurobiologically changes and mental well-being for specific attachment older adults with dementia before, during, and after the intervention.
Read the detailed description
This project contains three studies. Study 1 will use a randomized controlled trial to examine the effect of Paro (social robot) intervention on oxytocin, dopamine, and HRV variations for specific attachment older adults with dementia. A randomized controlled trial, single-blind, two parallel groups, and repeated measures design were used to examine the effects of Paro intervention on neurobiologically changes for specific attachment older adults with dementia before, during, and after the intervention. A sample of 120 older adults with dementia who are 65 years or older living in long-term care will be invited. Older adults will be randomly assigned to two groups: experimental group or control group. The outcomes will be assessed based on the change of dopamine and HRV at baseline, 3rd week during the Paro intervention, the end of intervention (6th week), and the 1 month after the Paro intervention. Furthermore, the change of oxytocin will be assessed at two time points: baseline and the end of Paro intervention. Study 2 will focus on the 60 participants of the 2 experimental groups. A mixed-method combined qualitative and quantitative research design will be used to explore the participating experience, group interaction, and its' association with mental health. Based on study 1 design, the outcomes of study 3 will be assessed based on the change of cognitive, executive functions, loneliness, depression, and well-being at the same points of study 1.
In addition, the Revised Adult Attachment Scale Chinese version (RAAS-C) will be used to classify the attachment types of the elderly. A sub-group analysis will be conducted to further understand the changes in the physical and mental health of the elderly with different attachment types after receiving Paro intervention. The results of this study will be used to provide empirical evidence to identify the effectiveness of Paro intervention on neurobiologically changes, cognition, executive functions, and mental well-being for older people with dementia. These results can be promoted as a care model in long-term facilities in the future.
- Conditions
- Dementia, Mild, Dementia Moderate, Cognitive Impairment
- Being tested
- Paro (social robot) intervention
- Keywords
- Dementia, Paro, Neurobiology, Cognitive Function, Mental well-being
- Medical subject headings
- Dementia, Lymphoma, Follicular, Cognitive Dysfunction, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paro (social robot) interventionDevice
Participants in the Paro group will receive a group (6-8 people as a group), facilitated, and 30-minute weekly session Paro intervention for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Paro intervention group | Experimental | Participants in the Paro intervention group will receive a group (6-8 people as a group), facilitated, and 30-minute weekly session Paro intervention for 6 weeks. Receives: Device: Paro (social robot) intervention |
| control group | No intervention | The control group will receive care as usual activities, such as painting, drawing, and craft, which are provided by each facility. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxytocin
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.
Measured: Change from Baseline Oxytocin at 6 weeks
Finger tapping test (FTT)
The FTT consists of tapping with the index finger on a computer mouse as many times as possible within 60 second.
Measured: Change from Baseline FTT at 6 weeks
HRV measurements
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.
Measured: Change from Baseline HRV at 6 weeks
The Chinese version of Mini-Mental State Examination (MMSE)
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.
Measured: Change from Baseline MMSE at 6 weeks
Core components of executive functions- WM and response inhibition
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.
Measured: Change from Baseline WM and response inhibition at 6 weeks
Core components of executive functions- WM(1) -Verbal WM task
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.
Measured: Change from Baseline Verbal WM task at 6 weeks
Core components of executive functions- WM(2)-Visuo-spatial WM task
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.
Measured: Change from Baseline Verbal WM task at 6 weeks
Core components of executive functions- response inhibition (1)-Color word Stroop task
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.
Measured: Change from Baseline Color word Stroop task at 6 weeks
Core components of executive functions- response inhibition (2)-Stop signal task
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.
Measured: Change from Baseline Stop signal task at 6 weeks
Core components of executive functions- response inhibition (3)-Go/no-go task
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.
Measured: Change from Baseline Go/no-go task at 6 weeks
Geriatric Depression Scale - Short Form (GDS-SF)
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.
Measured: Change from Baseline GDS-SF at 6 weeks
The UCLA Loneliness Scale version 3 (UCLA-3)
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.
Measured: Change from Baseline UCLA-3 at 6 weeks
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
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.
Measured: Change from Baseline WEMWBS at 6 weeks
Secondary outcomes (2)
Group atmosphere
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.
Measured: week-1, week-3 and week-10
Group satisfaction
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.
Measured: week-1, week-3 and week-6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start22 Mar 2022
- Primary completion24 May 2022
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia, MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trail, single-blind, two parallel groups, and repeated measures design
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Tainan Junior College of Nursing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shu-Chuan Chen, National Tainan Junior College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05102201
- Sponsor's protocol ID
- Shu-Chuan Chen
- Status last verified
- Sep 2022
- First submitted
- 15 Sep 2021
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD Sharing Access Criteria may be shared
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Tainan Junior College of Nursing
- ClinicalTrials.gov ID
- NCT05102201
- Acronym / sponsor ID
- Shu-Chuan Chen
- Conditions
- Dementia, Mild, Dementia Moderate, Cognitive Impairment
- Keywords
- Dementia, Paro, Neurobiology, Cognitive Function, Mental well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- National Tainan Junior College of NursingUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 1 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project contains three studies. This study will use a pilot randomized controlled trial to examine the effect of Paro (social robot) intervention on oxytocin, dopamine, and HRV variations and mental well-being for specific attachment older adults with dementia. A randomized controlled trial, single-blind, two parallel groups, and repeated measures design were used to examine the effects of Paro intervention on neurobiologically changes and mental well-being for specific attachment older adults with dementia before, during, and after the intervention.
Detailed description
This project contains three studies. Study 1 will use a randomized controlled trial to examine the effect of Paro (social robot) intervention on oxytocin, dopamine, and HRV variations for specific attachment older adults with dementia. A randomized controlled trial, single-blind, two parallel groups, and repeated measures design were used to examine the effects of Paro intervention on neurobiologically changes for specific attachment older adults with dementia before, during, and after the intervention. A sample of 120 older adults with dementia who are 65 years or older living in long-term care will be invited. Older adults will be randomly assigned to two groups: experimental group or control group. The outcomes will be assessed based on the change of dopamine and HRV at baseline, 3rd week during the Paro intervention, the end of intervention (6th week), and the 1 month after the Paro intervention. Furthermore, the change of oxytocin will be assessed at two time points: baseline and the end of Paro intervention. Study 2 will focus on the 60 participants of the 2 experimental groups. A mixed-method combined qualitative and quantitative research design will be used to explore the participating experience, group interaction, and its' association with mental health. Based on study 1 design, the outcomes of study 3 will be assessed based on the change of cognitive, executive functions, loneliness, depression, and well-being at the same points of study 1.
In addition, the Revised Adult Attachment Scale Chinese version (RAAS-C) will be used to classify the attachment types of the elderly. A sub-group analysis will be conducted to further understand the changes in the physical and mental health of the elderly with different attachment types after receiving Paro intervention. The results of this study will be used to provide empirical evidence to identify the effectiveness of Paro intervention on neurobiologically changes, cognition, executive functions, and mental well-being for older people with dementia. These results can be promoted as a care model in long-term facilities in the future.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled trail, single-blind, two parallel groups, and repeated measures design
| Arm | Type | Receives |
|---|---|---|
| Paro intervention group | Experimental | Device: Paro (social robot) interventionParticipants in the Paro intervention group will receive a group (6-8 people as a group), facilitated, and 30-minute weekly session Paro intervention for 6 weeks. |
| control group | No intervention | –The control group will receive care as usual activities, such as painting, drawing, and craft, which are provided by each facility. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- aged 65 years or over; (2) Mild to moderator dementia (3) an ability to communicate in Mandarin or Taiwanese; and (4) has been living in the LTC facility at least 3 months
Key exclusion criteria (1 listed)
- have severe difficulty in communication; (2) are totally dependent on carers for daily activity; (3) have a diagnosed infectious disease, severe dementia, and severe mental illness such as schizophrenia and delusional disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paro (social robot) interventionParticipants in the Paro group will receive a group (6-8 people as a group), facilitated, and 30-minute weekly session Paro intervention for 6 weeks | Device | Paro intervention group |
Primary outcome
Oxytocin
Time frame: 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.
Finger tapping test (FTT)
Time frame: 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.
HRV measurements
Time frame: 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.
The Chinese version of Mini-Mental State Examination (MMSE)
Time frame: 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.
Core components of executive functions- WM and response inhibition
Time frame: 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.
Core components of executive functions- WM(1) -Verbal WM task
Time frame: 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.
Core components of executive functions- WM(2)-Visuo-spatial WM task
Time frame: 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.
Core components of executive functions- response inhibition (1)-Color word Stroop task
Time frame: 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.
Core components of executive functions- response inhibition (2)-Stop signal task
Time frame: 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.
Core components of executive functions- response inhibition (3)-Go/no-go task
Time frame: 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.
Geriatric Depression Scale - Short Form (GDS-SF)
Time frame: 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.
The UCLA Loneliness Scale version 3 (UCLA-3)
Time frame: 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.
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Time frame: 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.
2 secondary outcomes
Group atmosphere
Time frame: week-1, week-3 and week-10
Group satisfaction
Time frame: week-1, week-3 and week-6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: Undecided. IPD Sharing Access Criteria may be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paro (social robot) intervention in people with Dementia, Mild and Dementia Moderate, run by National Tainan Junior College of Nursing at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxytocin (time frame: Change from Baseline Oxytocin at 6 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.