MindfulnessNCT05583695
Mindfulness-based Music Therapy in Blind Elderly Women
A study testing mindfulness-based music therapy, mindfulness-based therapy and routine care in people with Mindfulness and Music Therapy, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This trial aims to examine effects of mindfulness-based music therapy on mood regulation in blind elderly women. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Mindfulness, Music Therapy, Blind
- What is being tested?
- mindfulness-based music therapy, mindfulness-based therapy and routine care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2021to 31 May 2023
- 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
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- female
- blind with visual acuity (the best eye) of 20/400 or below
- aged 65 years or above
- cognitive intact, measured using Hong Kong Montreal Cognitive Assessment (6th version) with a score ≥ 12
- able to speak Cantonese
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mindfulness-based Music Therapy on Emotional Regulation in Blind Elderly Women
This trial aims to examine effects of mindfulness-based music therapy on mood regulation in blind elderly women.
- Conditions
- Mindfulness, Music Therapy, Blind, Elderly, Mood
- Being tested
- mindfulness-based music therapy, mindfulness-based therapy, routine care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mindfulness-based music therapyBehavioural
eight weekly sessions with a combination of both mindfulness and music therapy
mindfulness-based therapyBehavioural
eight weekly sessions of mindfulness
routine careBehavioural
eight weekly sessions of routine care
| Study group | Role | What they receive |
|---|---|---|
| mindfulness-based music therapy | Experimental | Not described Receives: Behavioral: mindfulness-based music therapy |
| mindfulness-based therapy | Experimental | Not described Receives: Behavioral: mindfulness-based therapy |
| routine care | Active comparator | Not described Receives: Behavioral: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulties in Emotion Regulation Scale (DERS)
Difficulties in Emotion Regulation Scale is a 36-item measure assessing six emotion regulation dimensions: non-acceptance, goals, impulse, strategies, clarity, and awareness. The total score ranges from 36 to 180. Higher scores represent more difficultly in regulating emotions.
Measured: at baseline
Difficulties in Emotion Regulation Scale (DERS)
Difficulties in Emotion Regulation Scale is a 36-item measure assessing six emotion regulation dimensions: non-acceptance, goals, impulse, strategies, clarity, and awareness. The total score ranges from 36 to 180. Higher scores represent more difficultly in regulating emotions.
Measured: In the 8th week from baseline
Secondary outcomes (4)
Depression Anxiety Stress Scales-21 (DASS-21)
Depression Anxiety Stress Scales-21 is a 21-item scale designed to assess depression, anxiety, and stress symptoms. It is divided into three subscales with each containing 7 items. Each subscale total score ranges from 0 to 21. Higher scores indicate more severe symptoms.
Measured: at baseline
Depression Anxiety Stress Scales-21 (DASS-21)
Depression Anxiety Stress Scales-21 is a 21-item scale designed to assess depression, anxiety, and stress symptoms. It is divided into three subscales with each containing 7 items. Each subscale total score ranges from 0 to 21. Higher scores indicate more severe symptoms.
Measured: In the 8th week from baseline
Geriatric Depression Scale (GDS)
Geriatric Depression Scale is a 30-item questionnaire asking how participants felt over the past week. The total score ranges from 0 to 30. Higher scores indicate more depressive symptoms.
Measured: at baseline
Geriatric Depression Scale (GDS)
Geriatric Depression Scale is a 30-item questionnaire asking how participants felt over the past week. The total score ranges from 0 to 30. Higher scores indicate more depressive symptoms.
Measured: In the 8th week from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start1 Jun 2021
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MindfulnessStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583695
- Sponsor's protocol ID
- RS-KHAB-2020-003
- Status last verified
- Jun 2023
- First submitted
- 12 Oct 2022
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan SHW, Cheung MYC, Chiu ATS, Leung MHT, Kuo MCC, Yip DYC, Hui CCY, Kam SWI, Yeung K, Mui DSP, Wang SM, Yip CCK. Clinical effectiveness of mindfulness-based music therapy on improving emotional regulation in blind older women: A randomized controlled trial. Integr Med Res. 2023 Dec;12(4):100993. doi: 10.1016/j.imr.2023.100993. Epub 2023 Aug 26.
PubMed 37915438
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mindfulness-based Music Therapy on Emotional Regulation in Blind Elderly Women
- ClinicalTrials.gov ID
- NCT05583695
- Acronym / sponsor ID
- RS-KHAB-2020-003
- Conditions
- Mindfulness, Music Therapy, Blind, Elderly, Mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 18 Oct 2022 (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 trial aims to examine effects of mindfulness-based music therapy on mood regulation in blind elderly women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mindfulness-based music therapy | Experimental | Behavioral: mindfulness-based music therapy |
| mindfulness-based therapy | Experimental | Behavioral: mindfulness-based therapy |
| routine care | Active comparator | Behavioral: routine care |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- female
- blind with visual acuity (the best eye) of 20/400 or below
- aged 65 years or above
- cognitive intact, measured using Hong Kong Montreal Cognitive Assessment (6th version) with a score ≥ 12
- able to speak Cantonese
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| mindfulness-based music therapyeight weekly sessions with a combination of both mindfulness and music therapy | Behavioural | mindfulness-based music therapy |
| mindfulness-based therapyeight weekly sessions of mindfulness | Behavioural | mindfulness-based therapy |
| routine careeight weekly sessions of routine care | Behavioural | routine care |
Primary outcome
Difficulties in Emotion Regulation Scale (DERS)
Time frame: at baseline
Difficulties in Emotion Regulation Scale is a 36-item measure assessing six emotion regulation dimensions: non-acceptance, goals, impulse, strategies, clarity, and awareness. The total score ranges from 36 to 180. Higher scores represent more difficultly in regulating emotions.
Difficulties in Emotion Regulation Scale (DERS)
Time frame: In the 8th week from baseline
Difficulties in Emotion Regulation Scale is a 36-item measure assessing six emotion regulation dimensions: non-acceptance, goals, impulse, strategies, clarity, and awareness. The total score ranges from 36 to 180. Higher scores represent more difficultly in regulating emotions.
4 secondary outcomes
Depression Anxiety Stress Scales-21 (DASS-21)
Time frame: at baseline
Depression Anxiety Stress Scales-21 (DASS-21)
Time frame: In the 8th week from baseline
Geriatric Depression Scale (GDS)
Time frame: at baseline
Geriatric Depression Scale (GDS)
Time frame: In the 8th week from baseline
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 26 Jun 2023.
- Derived from this study: PubMed 37915438Chan SHW, Cheung MYC, Chiu ATS, Leung MHT, Kuo MCC, Yip DYC, Hui CCY, Kam SWI, Yeung K, Mui DSP, Wang SM, Yip CCK. Clinical effectiveness of mindfulness-based music therapy on improving emotional regulation in blind older women: A randomized controlled trial. Integr Med Res. 2023 Dec;12(4):100993. doi: 10.1016/j.imr.2023.100993. Epub 2023 Aug 26.
- Individual participant dataSharing planned: No
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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 mindfulness-based music therapy, mindfulness-based therapy and routine care in people with Mindfulness and Music Therapy, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 5 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 26 Jun 2023. 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 Hong Kong. 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?
Difficulties in Emotion Regulation Scale (DERS) (time frame: at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05583695, which also lists 1 linked publication.
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 26 Jun 2023.